Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-04-09 @ 11:40 PM
Study NCT ID:
NCT05650333
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Centre', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 35 days after last dose (maximum up to Day 42)', 'description': 'Safety set evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'Ritlecitinib 20 mg QD', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '437.5', 'spread': '30', 'groupId': 'OG000', 'lowerLimit': '30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose]', 'description': 'Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.', 'unitOfMeasure': 'Nanogram*hours per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '208.7', 'spread': '38', 'groupId': 'OG000', 'lowerLimit': '38'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.500', 'spread': '0.450', 'groupId': 'OG000', 'lowerLimit': '0.450', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.70', 'spread': '30', 'groupId': 'OG000', 'lowerLimit': '30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'Liter per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.92', 'spread': '23', 'groupId': 'OG000', 'lowerLimit': '23'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Elimination Half-Life (t1/2) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.191', 'spread': '0.10776', 'groupId': 'OG000', 'lowerLimit': '0.10776'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren\'t included in analysis as they didn\'t have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121.0', 'groupId': 'OG000', 'lowerLimit': '74.7', 'upperLimit': '888.0'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'groupId': 'OG000', 'lowerLimit': '-555.0', 'upperLimit': '104.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 7', 'unitOfMeasure': 'Picogram per milliliter (pg/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in T Lymphocytes on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'title': 'CD3 cells: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.4'}]}]}, {'title': 'CD3 cells: Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '2.0'}]}]}, {'title': 'CD4 T helper lymphocytes: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.6'}]}]}, {'title': 'CD4 T helper lymphocytes: Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.1'}]}]}, {'title': 'CD8 T cytotoxic lymphocytes: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.5'}]}]}, {'title': 'CD8 T cytotoxic lymphocytes: Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 7', 'description': 'T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in B Lymphocytes on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '439.0', 'groupId': 'OG000', 'lowerLimit': '191.0', 'upperLimit': '881.0'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.0', 'groupId': 'OG000', 'lowerLimit': '-116.0', 'upperLimit': '766.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 7', 'description': 'B lymphocytes included CD19 cells.', 'unitOfMeasure': '10^6 cells per liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Natural Killer (NK) Cells on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254.0', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '729.0'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.5', 'groupId': 'OG000', 'lowerLimit': '-318.0', 'upperLimit': '627.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 7', 'unitOfMeasure': '10^6 cells per liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Leading to Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 7', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 7', 'description': 'Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 7', 'description': 'Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'classes': [{'title': 'Day 1: Taste Score', 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Mouthfeel Score', 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Volume Score', 'categories': [{'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Taste Score', 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Mouthfeel Score', 'categories': [{'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7: Volume Score', 'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and 7', 'description': 'The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'periods': [{'title': 'Treatment Period (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Follow-up (35 Days After Last Dose)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All enrolled participants were followed-up.', 'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 15 participants, 6 to less than 12 years of age with greater than or equal to (\\>=) 50% scalp hair loss due to alopecia areata, were enrolled. Study started from 02 March 2023 and completed on 11 August 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ritlecitinib 20 mg', 'description': 'Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who were enrolled in the study and were assigned to study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-03', 'size': 1176248, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-25T12:48', 'hasProtocol': True}, {'date': '2022-11-15', 'size': 398971, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-25T12:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2022-12-06', 'resultsFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2022-12-06', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-25', 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7', 'timeFrame': 'Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose]', 'description': 'Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7'}, {'measure': 'Apparent Oral Clearance (CL/F) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.'}, {'measure': 'Elimination Half-Life (t1/2) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7', 'description': 'Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase.'}, {'measure': 'Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7', 'timeFrame': 'Baseline and Day 7'}, {'measure': 'Change From Baseline in T Lymphocytes on Day 7', 'timeFrame': 'Baseline and Day 7', 'description': 'T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes.'}, {'measure': 'Change From Baseline in B Lymphocytes on Day 7', 'timeFrame': 'Baseline and Day 7', 'description': 'B lymphocytes included CD19 cells.'}, {'measure': 'Change From Baseline in Natural Killer (NK) Cells on Day 7', 'timeFrame': 'Baseline and Day 7'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Treatment Related AEs', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator.'}, {'measure': 'Number of Participants With Serious AEs (SAEs)', 'timeFrame': 'Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With AEs Leading to Treatment Discontinuation', 'timeFrame': 'Day 1 up to Day 7', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'timeFrame': 'Day 1 up to Day 7', 'description': 'Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values', 'timeFrame': 'Day 1 up to Day 7', 'description': 'Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator.'}, {'measure': 'Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire', 'timeFrame': 'Day 1 and 7', 'description': 'The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'referencesModule': {'references': [{'pmid': '39924925', 'type': 'DERIVED', 'citation': 'Gonzalez ME, Browning J, Smith S, Plotka A, Zhu JD, Parvatini S, Huh Y, Wolk R. A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata. Pediatr Dermatol. 2025 Jul-Aug;42(4):742-746. doi: 10.1111/pde.15895. Epub 2025 Feb 9.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7981031', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the pharmacokinetics (how the medicine is changed and eliminated from your body after you take it) and pharmacodynamics (effects of the medicine in the body) of the study medicine (called Ritlecitinib) in children of 6 to \\<12 years of age with Alopecia Areata, a condition of scalp hair loss. 12 children with alopecia areata will be participating in this study. All participants will receive study medicine with a dose of 20 milligram (mg) orally once daily for 7 days. 5 blood samples will be collected on day 7 for pharmacokinetic evaluation and 2 blood samples each at screening and on Day 7 will be collected for pharmacodynamic evaluation. Participants will take part in the study for about 10 weeks.', 'detailedDescription': 'This is an interventional, Pharmacokinetic (PK), Pharmacodynamic (PD), phase 1, open label study in children 6 to less than 12 years of age with ≥50% scalp hair loss due to severe alopecia areata. The purpose of the study is to collect data to support dose selection for subsequent studies in the same population.\n\nParticipants will be screened and, if all eligibility criteria are met, will receive the first dose of Investigational product within 28 days after the screening visit.\n\nParticipants will receive 20 mg ritlecitinib in one dose, daily, for 7 consecutive days. Blood samples for pharmacodynamic evaluation will be collected on screening and Day 7. Blood samples for pharmacokinetic evaluation will be collected on Day 7 at: 0 hr (pre-dose), 0.5 hr, 1 hr, 3 hrs, and 8 hrs after dosing.\n\nAt least 12 evaluable participants with respect to the primary endpoint will be enrolled in the study.\n\nParticipants and their parents/legal guardians will be required to visit the study site 3 times during the study (Screening, Day 1 and Day 7) A safety follow-up visit will be conducted by phone, 28 to 35 days after the last dose of ritlecitinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion criteria:\n\n1. Participants who are 6 to less than12 years old at the baseline visit.\n2. A diagnosis of severe AA, including AT and AU, with ≥50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits, without evidence of terminal hair regrowth within the previous 12 months.\n\nKey Exclusion Criteria:\n\n1. A known congenital cause of AA, other systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc) or other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc).\n2. Any present malignancies or history of malignancies, history of any lymphoproliferative disorder\n3. History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.\n4. Other medical or psychiatric condition (including recent \\[within the past year\\] or active suicidal ideation/behavior) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n5. Not up to date with all age appropriate vaccines (including 2-dose vaccination for varicella) or vaccination with attenuated live vaccine within 6 weeks of first dose of study medicine."}, 'identificationModule': {'nctId': 'NCT05650333', 'briefTitle': 'A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN INTERVENTIONAL PK, PD, PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE PK AND PD OF MULTIPLE-DOSE RITLECITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA', 'orgStudyIdInfo': {'id': 'B7981031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ritlecitinib 20 mg', 'description': 'Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).', 'interventionNames': ['Drug: Ritlecitinib 20 mg']}], 'interventions': [{'name': 'Ritlecitinib 20 mg', 'type': 'DRUG', 'description': 'orally administered, Ritlecitinib 20 mg once daily (QD)', 'armGroupLabels': ['Ritlecitinib 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology & Clinical Research Institute', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatric Skin Research,LLC', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'UNMH', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Vital Prospects Clinical Research Institute, PC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Dermatology Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Dermatology and Laser Specialists', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}