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

NCT07733765 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: B7981110
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 4

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (47)

• 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

Study Arms (2)

Ritlecitinib 50 milligrams (mg)

EXPERIMENTAL

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.

Drug: Ritlecitinib 100 mg; Drug: Ritlecitinib 50 mg

Placebo

PLACEBO COMPARATOR

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.

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

Interventions

Ritlecitinib 100 mg DRUG

100 mg capsule taken orally once daily

Placebo; Ritlecitinib 50 milligrams (mg)

Ritlecitinib 50 mg DRUG

50 mg capsule taken orally once daily

Placebo; Ritlecitinib 50 milligrams (mg)

Placebo OTHER

Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Center for Clinical Studies - Houston - Binz Street

Houston, Texas, 77004, United States

Location

Center for Clinical Studies, LTD. LLP

Houston, Texas, 77004, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): April 27, 2028
• Study Completion (Estimated): April 27, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (4)