Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 10:28 AM
Study NCT ID:
NCT05044234
Status:
TERMINATED
Last Update Posted:
2023-11-29
First Post:
2021-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively.', 'description': 'TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 8, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 4, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 9, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 16, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ELECTROCARDIOGRAM QT PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CERVICAL VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '52.2'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '22.2'}, {'value': '41.7', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '69.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '42.9'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '22.2'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '60.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'description': 'The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \\>0, \\<1.5; Mild (2) = mean ≥1.5, \\<2.5; Moderate (3) = mean ≥2.5, \\<3.5; and Severe (4) = mean ≥3.5.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.0'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '31.2', 'upperLimit': '83.1'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '64.9'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '40.0', 'upperLimit': '93.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '32.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '60.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '24.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '37.8'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'OG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '84.6'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '68.8'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '29.6', 'upperLimit': '90.4'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '40.0', 'upperLimit': '93.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 16', 'description': 'The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'FG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'FG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'FG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Delayed data entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'ITT population: all randomized participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '156', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'BG001', 'title': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'BG002', 'title': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'BG003', 'title': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '12.14', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '10.13', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '13.46', 'groupId': 'BG002'}, {'value': '47.5', 'spread': '12.11', 'groupId': 'BG003'}, {'value': '46.6', 'spread': '12.07', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Psoriasis Area and Severity Index (PASI) Score at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '20.11', 'spread': '10.031', 'groupId': 'BG000'}, {'value': '19.78', 'spread': '8.698', 'groupId': 'BG001'}, {'value': '20.58', 'spread': '8.489', 'groupId': 'BG002'}, {'value': '18.24', 'spread': '8.048', 'groupId': 'BG003'}, {'value': '19.68', 'spread': '8.806', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Static Physicians Global Assessment (sPGA)--No. of participants with score of 3 or 4 at Baseline', 'classes': [{'categories': [{'title': 'Baseline score of 3', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Baseline score of 4', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population: all randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-13', 'size': 1783386, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-06T18:52', 'hasProtocol': True}, {'date': '2022-12-15', 'size': 460488, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-06T18:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'whyStopped': 'Company Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2021-09-07', 'resultsFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-06', 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16', 'timeFrame': 'At Week 16', 'description': 'The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \\>0, \\<1.5; Mild (2) = mean ≥1.5, \\<2.5; Moderate (3) = mean ≥2.5, \\<3.5; and Severe (4) = mean ≥3.5.'}, {'measure': 'Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.'}, {'measure': 'Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.'}, {'measure': 'Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \\* 100.'}, {'measure': 'Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline', 'timeFrame': 'Baseline, Week 16', 'description': 'The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.'}, {'measure': 'Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline', 'timeFrame': 'Baseline, Week 16', 'description': 'The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Plaque Psoriasis', 'Cedirogant', 'ABBV-157'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.\n\nCedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.\n\nParticipants received oral daily doses of cedirogant or placebo capsules for 16 weeks.\n\nThere may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.\n\nExclusion Criteria:\n\n* Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.\n* Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.'}, 'identificationModule': {'nctId': 'NCT05044234', 'briefTitle': 'A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': 'M18-816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '75 mg Cedirogant', 'description': 'Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.', 'interventionNames': ['Drug: Cedirogant']}, {'type': 'EXPERIMENTAL', 'label': '150 mg Cedirogant', 'description': 'Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.', 'interventionNames': ['Drug: Cedirogant']}, {'type': 'PLACEBO_COMPARATOR', 'label': '375 mg Cedirogant', 'description': 'Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.', 'interventionNames': ['Drug: Cedirogant']}], 'interventions': [{'name': 'Cedirogant', 'type': 'DRUG', 'otherNames': ['ABBV-157'], 'description': 'Capsule, Oral', 'armGroupLabels': ['150 mg Cedirogant', '375 mg Cedirogant', '75 mg Cedirogant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Dermatology /ID# 238563', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006-2722', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Dermatology Specialist /ID# 238518', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Research Trials, LLC /ID# 238687', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Encino Research Center /ID# 245950', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '91606', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Inc. /ID# 239536', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medderm Associates /ID# 238834', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakes Research, 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'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30534-6369', 'city': 'Dawsonville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cleaver Medical Group Dermatology - Dawsonville /ID# 246327', 'geoPoint': {'lat': 34.42121, 'lon': -84.11908}}, {'zip': '30060-1047', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marietta Dermatology Clinical Research /ID# 238679', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arlington Dermatology /ID# 238701', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin, LLC /ID# 238704', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55424-1200', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Zel Skin & Laser Specialists - Edina /ID# 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'Canada', 'facility': 'K. Papp Clinical Research /ID# 239695', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital /ID# 239286', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '080-0013', 'city': 'Obihiro-shi', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Takagi Dermatology Clinic /ID# 239274'}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'JR Sapporo Hospital /ID# 239277', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie University Hospital /ID# 239275', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Okayama University Hospital /ID# 239285', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '573-1191', 'city': 'Hirakata-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kansai Medical University Hospital /ID# 239278'}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu University Hospital /ID# 239346', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '105-8471', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Jikei University Hospital /ID# 239319'}, {'zip': '141-8625', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'NTT Medical Center Tokyo /ID# 239287'}, {'zip': '160-0023', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical University Hospital /ID# 239320'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}