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Clinical Trials in Japan / NCT07733765
Recruiting Phase 3

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 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-07-30
Last updated
2026-09-10

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

Ritlecitinib 100 mg →Ritlecitinib 50 mg →Placebo

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

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo — Week 24

Trial sites (20)

FacilityCityRegionStatus
California Dermatology & Clinical Research Institute Encinitas California Not Yet Recruiting
Skin Research of South Florida Miami Florida Recruiting
Endeavor Health Skokie Illinois Not Yet Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Not Yet Recruiting
Cutaneous Translational Research Program (CTReP) Baltimore Maryland Not Yet Recruiting
Johns Hopkins Hospital Investigational Drug Services (IDS) Pharmacy Baltimore Maryland Not Yet Recruiting
Revival Research Institute, LLC Troy Michigan Recruiting
Clinical and Translational Research Center (CTRC) Chapel Hill North Carolina Not Yet Recruiting
UNC Dermatology and Skin Cancer Center Chapel Hill North Carolina Not Yet Recruiting
Bexley Dermatology Research Bexley Ohio Not Yet Recruiting
NW Dermatology Institute Portland Oregon Not Yet Recruiting
Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania Recruiting
Center for Clinical Studies, LTD. LLP Houston Texas Not Yet Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Recruiting
Dermatology Specialists of Spokane Spokane Washington Not Yet Recruiting
Principle Research Solutions Spokane Washington Not Yet Recruiting
Centre de Recherche Saint-Louis (Québec) Québec Quebec Not Yet Recruiting
Hospital of the University of Occupational and Environmental Health, Japan Kitakyushu-shi Fukuoka Not Yet Recruiting
Niigata University Medical & Dental Hospital Niigata Japan Recruiting

More Pfizer trials in Japan

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer Active, not recruiting
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies Recruiting
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. Recruiting
Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Recruiting
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib Active, not recruiting

Other trials for the same condition

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata Active, not recruiting
A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa Recruiting
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib Active, not recruiting
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata Recruiting
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07733765 on ClinicalTrials.gov ↗ ← All trials in Japan