Recruiting
Phase 3

Ritlecitinib

Sponsor:

Pfizer

Code:

NCT07733765

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Ritlecitinib 100 mg

Ritlecitinib 50 mg

Placebo

Study Details

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

Study ID

NCT07733765

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Apr 26, 2028

Anticipated

Primary completion date

Apr 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

336 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ritlecitinib 50 milligrams (mg)

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.

placebo comparator: Placebo

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.

Interventions

Ritlecitinib 100 mg

100 mg capsule taken orally once daily

Ritlecitinib 50 mg

50 mg capsule taken orally once daily

Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Revival Research Institute, LLC

Recruiting

Troy, Michigan, United States, 48084

Dermatology Associates of Plymouth Meeting

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

More Information

Sponsor

Pfizer

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-24.