A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA
A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
Kawai Norisuke
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Clinical Trials Information Desk
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Pending
Oct. 02, 2026
336
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
*18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled.
*Have a clinical diagnosis of AA with no other etiology of hair loss.
*Have >20% to <50% hair loss of the scalp, as measured by SALT.
*Current AA episode of hair loss >=6 months and <=10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).
Diseases or conditions affecting hair loss, including:
*Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
*Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).
*Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
12age old over
No limit
Both
Alopecia Areata
*Ritlecitinib 50 mg
Participants will receive 1 ritlecitinib 50 mg capsule QD orally from Day 1 to Week 24.
At Week 24:
- Responders will be allocated to the below:
Arm 1A (Ritlecitinib 50 mg R Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
- Non-Responders will be re-randomized to either of the below:
Arm 1B (Ritlecitinib 50 mg NR-->50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
Arm 1C (Ritlecitinib 50 mg NR-->100 mg Group): 1 ritlecitinib 100 mg capsule QD and 1 placebo 50 mg capsule QD orally through Week 48.
*Placebo
Participants will receive 1 placebo 50 mg capsule QD orally from Day 1 to Week 24
At Week 24:
- Responders will be allocated to the below:
Arm 2A (Placebo R Group): 1 placebo 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
- Non-Responders will be allocated to the below:
Arm 2B (Placebo NR-->Ritlecitinib 50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
*Difference in the proportion of SALT <=5 responders at Week(W) 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT <=10 responders at W24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT 75 responders at W24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT 90 responders at W24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the mean change from baseline (CFB) in SALT score at W8, 12, 18, 24 for ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at W24
*Difference in the proportion of SALT 0 responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT <=10 responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT <=5 responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT 75 responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of SALT 90 responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Eyebrow Assessment (EBA) responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Eyelash Assessment (ELA) responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of PGI-C responders at W8, 12, 18 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Patient's Satisfaction with Hair Growth (P-Sat) responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at W8, 12, 18, 24 between ritlecitinib 50 mg QD versus Placebo
*Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected from Screening to Follow up period (up to 57 weeks)
*Proportion of responders for SALT 0 at appliable timepoints after W24 (W28, 36, 48) for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR-->50 mg Group, Ritlecitinib 50 mg NR-->100 mg Group, Placebo NR-->Ritlecitinib 50 mg Group, Placebo R Group)
*Proportion of responders for SALT <=10 at appliable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for SALT <=5 at appliable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for SALT 75 at appliable timepoints after W24 (W 28, 36, 48) for each of the 5 groups
*Proportion of responders for SALT 90 at appliable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Difference in the proportion of SALT 0 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of SALT<=10 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of SALT<=5 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of SALT75 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of SALT90 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Mean CFB in SALT score at applicable timepoints after Week 24 (W28, 36, 48) for each of the 5 groups
*Difference in the mean CFB in SALT score at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Proportion of responders for EBA at appliable timepoints after Week 24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for ELA at appliable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Difference in the proportion of EBA responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of ELA responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Proportion of PGI-C responders at applicable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Proportion of P-Sat responders at applicable timepoints after Week 24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after W24 (W28, 36, 48) for each of the 5 groups
*Difference in the proportion of PGI-C responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of P-Sat responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after W24 (W28, 36, 48) between Ritlecitinib 50 mg NR-->50 mg Group and Ritlecitinib 50 mg NR-->100 mg Group
*Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected from Screening to Follow up period (up to 57 weeks)
Pfizer Japan Inc.
Niigata University Medical & Dental Hospital Institutional Review Board
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.
