Alopecia Areata
Conditions
Brief summary
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.
Interventions
100 mg capsule taken orally once daily
50 mg capsule taken orally once daily
OTHERPlacebo
Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * 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). Key
Exclusion criteria
1\. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus | Week 24 | — |
| Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus | Week 24 | — |
| Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus | Week 24 | — |
| Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus | 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 | 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 | Week 24 | — |
| Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo | Weeks 8, 12, 18 | — |
| Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo | Weeks 8, 12, 18 | — |
| Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo | Weeks 8, 12, 18 | — |
| Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo | Weeks 8, 12, 18 | — |
| Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo | Weeks 8, 12, 18 | — |
| Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Screening to Follow up period (up to week 57) | — |
| Proportion of responders for SALT 0 at appliable timepoints after Week 24 | Weeks 28, 36, and 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 Week 24 | Weeks 28, 36, and 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 ≤5 at appliable timepoints after Week 24 | Weeks 28, 36, and 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 75 at appliable timepoints after Week 24 | Weeks 28, 36, and 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 90 at appliable timepoints after Week 24 | Weeks 28, 36, and 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) |
| 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 | 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 | 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 | 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 | 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 | Weeks 28, 36, and 48 | — |
| Mean CFB in SALT score at applicable timepoints after Week 24 | Weeks 28, 36, and 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) |
| 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 | Weeks 28, 36, and 48 | — |
| Proportion of responders for EBA at appliable timepoints after Week 24 | Weeks 28, 36, and 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 ELA at appliable timepoints after Week 24 | Weeks 28, 36, and 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) |
| 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 | 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 | Weeks 28, 36, and 48 | — |
| Proportion of PGI-C responders at applicable timepoints after Week 24 | Weeks 28, 36, and 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 P-Sat responders at applicable timepoints after Week 24 | Weeks 28, 36, and 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 Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24 | Weeks 28, 36, and 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 Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24 | Weeks 28, 36, and 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 Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24 | Weeks 28, 36, and 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) |
| 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 | 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 | 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 | 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 | 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 | 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 | Screening to Follow up period (up to 57 weeks) | — |
Countries
Canada, Japan, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed