Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-06 @ 11:11 AM
Study NCT ID:
NCT03899259
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-595-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up to 36 Weeks', 'description': 'All randomized participants who received at least one dose of study drug, and did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit.\n\nGender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 28, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 39, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 63, 'seriousNumAtRisk': 233, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Strangulated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sars-cov-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.4'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '24.0'}, {'value': '32.5', 'groupId': 'OG002', 'lowerLimit': '26.8', 'upperLimit': '38.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.86', 'ciLowerLimit': '2.79', 'ciUpperLimit': '22.17', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.72', 'ciLowerLimit': '7.30', 'ciUpperLimit': '53.30', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in SALT Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.96', 'spread': '2.723', 'groupId': 'OG000'}, {'value': '-28.21', 'spread': '2.770', 'groupId': 'OG001'}, {'value': '-47.45', 'spread': '2.229', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.25', 'ciLowerLimit': '-32.78', 'ciUpperLimit': '-17.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.834', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.49', 'ciLowerLimit': '-51.33', 'ciUpperLimit': '-37.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.482', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'SALT uses a visual aid showing the division of the scalp hair into4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\\< 4 years versus ≥4 years), treatment group, and baseline value in the model.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with nonmissing baseline and at least one postbaseline measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.4'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '16.8'}, {'value': '23.5', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '29.3'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.63', 'ciLowerLimit': '1.58', 'ciUpperLimit': '13.60', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.94', 'ciLowerLimit': '4.72', 'ciUpperLimit': '35.44', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '8.4'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '22.8'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '28.4', 'upperLimit': '41.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.36', 'ciLowerLimit': '1.77', 'ciUpperLimit': '10.74', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.37', 'ciLowerLimit': '5.75', 'ciUpperLimit': '31.10', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': "PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline PRO for scalp hair assessment score of ≥ 3.'}, {'type': 'SECONDARY', 'title': 'Time for Participants to Achieve SALT ≤ 20', 'timeFrame': 'Week 52', 'description': 'Time for participants to achieve SALT ≤ 20', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '10.0'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '19.1'}, {'value': '34.8', 'groupId': 'OG002', 'lowerLimit': '27.9', 'upperLimit': '42.4'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '0.91', 'ciUpperLimit': '7.24', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.30', 'ciLowerLimit': '4.12', 'ciUpperLimit': '25.77', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': "ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '12.4'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '18.1'}, {'value': '34.3', 'groupId': 'OG002', 'lowerLimit': '26.9', 'upperLimit': '42.5'}]}]}], 'analyses': [{'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.63', 'ciUpperLimit': '5.62', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.10', 'ciLowerLimit': '3.18', 'ciUpperLimit': '20.66', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline ClinRO measure for EL hair loss ≥ 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '10.5'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '22.7'}, {'value': '35.8', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '43.3'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '1.25', 'ciUpperLimit': '9.40', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.85', 'ciLowerLimit': '4.32', 'ciUpperLimit': '27.25', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': "PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline PRO measures for EB hair loss ≥2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.1'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '28.2'}, {'value': '34.6', 'groupId': 'OG002', 'lowerLimit': '27.0', 'upperLimit': '43.0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.63', 'ciLowerLimit': '2.73', 'ciUpperLimit': '78.42', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.37', 'ciLowerLimit': '5.93', 'ciUpperLimit': '99.99', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': "PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline PRO Measure EL hair loss ≥2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '1.415', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '1.425', 'groupId': 'OG001'}, {'value': '-3.04', 'spread': '1.138', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.02', 'ciLowerLimit': '-6.91', 'ciUpperLimit': '0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.981', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.21', 'ciLowerLimit': '-7.75', 'ciUpperLimit': '-0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.799', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline Skindex-16 AA Symptoms Domain Score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, QD one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.98', 'spread': '2.154', 'groupId': 'OG000'}, {'value': '-18.73', 'spread': '2.171', 'groupId': 'OG001'}, {'value': '-25.40', 'spread': '1.732', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.75', 'ciLowerLimit': '-12.68', 'ciUpperLimit': '-0.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.017', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.42', 'ciLowerLimit': '-18.80', 'ciUpperLimit': '-8.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.737', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline Skindex-16 AA emotions domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.67', 'spread': '1.913', 'groupId': 'OG000'}, {'value': '-14.05', 'spread': '1.925', 'groupId': 'OG001'}, {'value': '-18.00', 'spread': '1.535', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.38', 'ciLowerLimit': '-9.65', 'ciUpperLimit': '0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.680', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.33', 'ciLowerLimit': '-13.10', 'ciUpperLimit': '-3.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.429', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.227', 'groupId': 'OG001'}, {'value': '-1.19', 'spread': '0.181', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.518', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.315', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.286', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.\n\nLS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline HADS anxiety score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in HADS Depression Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally QD, one placebo tablet administered orally QD to maintain blind.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.208', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.167', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.291', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.264', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline,Week 36', 'description': 'The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.\n\nLS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one postbaseline HADS depression score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'FG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.'}, {'id': 'FG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '234'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ongoing Study Participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '210'}]}]}], 'preAssignmentDetails': 'Results for maximum extended enrollment (MEE) participants will be posted after the study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets administered orally QD to maintain the blind.'}, {'id': 'BG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind..'}, {'id': 'BG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '545', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37.10', 'spread': '12.35', 'groupId': 'BG000'}, {'value': '39.00', 'spread': '12.99', 'groupId': 'BG001'}, {'value': '38.00', 'spread': '12.65', 'groupId': 'BG002'}, {'value': '38.00', 'spread': '12.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant was randomized inadvertently but not dosed and age was not obtained.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Disease Severity of Alopecia Tool (SALT) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '546', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '85', 'spread': '17.79', 'groupId': 'BG000'}, {'value': '85.6', 'spread': '18.08', 'groupId': 'BG001'}, {'value': '84.8', 'spread': '18.08', 'groupId': 'BG002'}, {'value': '85.1', 'spread': '17.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'SALT uses a visual aid showing the division of the scalp hair into 4 areas - top of the head constituting 40% of total surface, the posterior/back of head 24%, right and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account for scoring. The score will range from 0% to 100%, with lower score indicating better health outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-02', 'size': 970639, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-21T09:21', 'hasProtocol': True}, {'date': '2021-02-22', 'size': 4353193, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-21T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 546}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2022-01-24', 'completionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2019-04-01', 'resultsFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2019-04-01', 'dispFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20', 'timeFrame': 'Week 36', 'description': 'The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in SALT Score at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'SALT uses a visual aid showing the division of the scalp hair into4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\\< 4 years versus ≥4 years), treatment group, and baseline value in the model.'}, {'measure': 'Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)', 'timeFrame': 'Week 12', 'description': 'SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.'}, {'measure': 'Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline', 'timeFrame': 'Week 36', 'description': "PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair)."}, {'measure': 'Time for Participants to Achieve SALT ≤ 20', 'timeFrame': 'Week 52', 'description': 'Time for participants to achieve SALT ≤ 20'}, {'measure': 'Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline)', 'timeFrame': 'Week 36', 'description': "ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB."}, {'measure': 'Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline)', 'timeFrame': 'Week 36', 'description': 'ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.'}, {'measure': 'Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)', 'timeFrame': 'Week 36', 'description': "PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs."}, {'measure': 'Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline)', 'timeFrame': 'Week 36', 'description': "PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair."}, {'measure': 'Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.'}, {'measure': 'Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.'}, {'measure': 'Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.\n\nLS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.'}, {'measure': 'Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.\n\nLS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.'}, {'measure': 'Mean Change From Baseline in HADS Depression Score at Week 36', 'timeFrame': 'Baseline,Week 36', 'description': 'The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.\n\nLS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '40214720', 'type': 'DERIVED', 'citation': 'King B, Mostaghimi A, Shimomura Y, Piraccini BM, Blume-Peytavi U, Sontag A, Dutronc Y, Denning K, Kolodsick J, Lu X, Srivastava A, Sinclair R. Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment. Am J Clin Dermatol. 2025 Jul;26(4):611-622. doi: 10.1007/s40257-025-00932-0. Epub 2025 Apr 11.'}, {'pmid': '38904749', 'type': 'DERIVED', 'citation': 'Craiglow B, Lee YW, Vano-Galvan S, Egeberg A, Dutronc Y, Durand F, Pierce E, Yu G, Chen YF, Mostaghimi A. Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib. Dermatol Ther (Heidelb). 2024 Jul;14(7):1959-1968. doi: 10.1007/s13555-024-01208-x. Epub 2024 Jun 21.'}, {'pmid': '37991697', 'type': 'DERIVED', 'citation': 'Senna MM, Kwon O, Piraccini BM, Sinclair R, Ball S, Ding Y, Chen YF, Dutronc Y, King B. Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata. Dermatol Ther (Heidelb). 2023 Dec;13(12):3209-3220. doi: 10.1007/s13555-023-01063-2. Epub 2023 Nov 22.'}, {'pmid': '37556146', 'type': 'DERIVED', 'citation': 'Ko JM, Mayo TT, Bergfeld WF, Dutronc Y, Yu G, Ball SG, Somani N, Craiglow BG. Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. JAMA Dermatol. 2023 Sep 1;159(9):970-976. doi: 10.1001/jamadermatol.2023.2581.'}, {'pmid': '37381691', 'type': 'DERIVED', 'citation': 'Piraccini BM, Ohyama M, Craiglow B, Bewley A, Ding Y, Chen YF, Dutronc Y, Pierce E, Durand F, Mostaghimi A. Scalp hair regrowth is associated with improvements in health-related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials. J Dermatolog Treat. 2023 Dec;34(1):2227299. doi: 10.1080/09546634.2023.2227299.'}, {'pmid': '36855020', 'type': 'DERIVED', 'citation': 'Kwon O, Senna MM, Sinclair R, Ito T, Dutronc Y, Lin CY, Yu G, Chiasserini C, McCollam J, Wu WS, King B. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 May;24(3):443-451. doi: 10.1007/s40257-023-00764-w. Epub 2023 Mar 1.'}, {'pmid': '36763878', 'type': 'DERIVED', 'citation': 'King B, Mostaghimi A, Shimomura Y, Zlotogorski A, Choi GS, Blume-Peytavi U, Passeron T, Holzwarth K, Dutronc Y, McCollam J, Yang FE, Stanley S, Wu WS, Sinclair R. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Br J Dermatol. 2023 Feb 10;188(2):218-227. doi: 10.1093/bjd/ljac059.'}, {'pmid': '35334197', 'type': 'DERIVED', 'citation': 'King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/10fuouLYVPNjWekNxnfJoE', 'label': 'A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata'}]}, 'descriptionModule': {'briefSummary': 'The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.\n* Have severe or very severe AA, as determined by all of the following:\n\n * Current AA episode of more than 6 months\' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.\n * No spontaneous improvement over the past 6 months.\n * Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.\n* Male or nonpregnant, nonbreastfeeding female participants.\n\nExclusion Criteria:\n\n* Primarily "diffuse" type of AA.\n* Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.\n* Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).'}, 'identificationModule': {'nctId': 'NCT03899259', 'acronym': 'BRAVE-AA2', 'briefTitle': 'A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata', 'orgStudyIdInfo': {'id': '16978'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JAIR', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 Milligram (mg) Baricitinib', 'description': 'Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2 mg Baricitinib', 'description': 'Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received two 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