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

Official title

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

Overview

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

• Drug Ritlecitinib 100 mg
  100 mg capsule taken orally once daily
• Drug Ritlecitinib 50 mg
  50 mg capsule taken orally once daily
• Other Placebo
  Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily

Primary outcome measures

• 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]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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).

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Dawes Fretzin Clinical Research Group, LLC — Indianapolis
• University of Iowa Hospitals & Clinics — Iowa City
• Center for Clinical Studies - Houston - Binz Street — Houston
• Center for Clinical Studies, LTD. LLP — Houston

Identifiers

NCT: NCT07733765 · B7981110

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗