The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA). This study is seeking participants who are * 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss. Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks. About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone. We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
336
100 mg capsule taken orally once daily
50 mg capsule taken orally once daily
Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily
California Dermatology & Clinical Research Institute
Encinitas, California, United States
NOT_YET_RECRUITINGSkin Research of South Florida
Miami, Florida, United States
RECRUITINGEndeavor Health
Skokie, Illinois, United States
NOT_YET_RECRUITINGDawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGCutaneous Translational Research Program (CTReP)
Baltimore, Maryland, United States
NOT_YET_RECRUITINGJohns Hopkins Hospital Investigational Drug Services (IDS) Pharmacy
Baltimore, Maryland, United States
NOT_YET_RECRUITINGRevival Research Institute, LLC
Troy, Michigan, United States
RECRUITINGClinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITINGUNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITING...and 10 more locations
Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Week 24
Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18 and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Week 24
Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period
Time frame: Screening to Follow up period (up to week 57)
Proportion of responders for SALT 0 at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT ≤10 at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT ≤5 at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT 75 at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT 90 at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Mean CFB in SALT score at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Proportion of responders for EBA at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for ELA at appliable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Proportion of PGI-C responders at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of P-Sat responders at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24
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)
Time frame: Weeks 28, 36, and 48
Difference in the proportion of PGI-C responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of P-SAT responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected during the safety follow-up period
Time frame: Screening to Follow up period (up to 57 weeks)
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