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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Alopecia Areata

Treatments: Other: Placebo; Drug: Ritlecitinib 50 mg; Drug: Ritlecitinib 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07733765

B7981110

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 2 patient groups, including a placebo group

Ritlecitinib 50 milligrams (mg)

Experimental group

Description:

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.

Treatment:

Drug: Ritlecitinib 100 mg

Drug: Ritlecitinib 50 mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ritlecitinib 100 mg

Drug: Ritlecitinib 50 mg

Other: Placebo