A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

Phase 3

Recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: Ritlecitinib 100 mg; Drug: Ritlecitinib 50 mg; Drug: Placebo - 50 mg; Drug: Placebo - 100 mg

• Registration Number: NCT06873945
• Lead Sponsor: Pfizer

Brief Summary

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.

Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.

This study is seeking participants who:

* Are 12 years of age or older

* Have a diagnosis of alopecia areata

* Have lost 50% or more of the hair on their scalp

* Do not have any other conditions that causes hair loss

* Are willing to stop all other treatments that they may be taking for alopecia areata

About 550 participants will take part in in this study.

Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.

The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.

People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:

* alopecia areata assessment,

* physical examinations,

* hearing tests,

* blood tests,

* x-ray,

* ECG (electrocardiogram),

* photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-13
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-03-09
• Study Completion: 2027-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Age:

1. 18 years of age or older 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.

   Disease Characteristics:

2. Must meet the following alopecia areata criteria at both Screening and Baseline:

   1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
   2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
   3. Current episode of hair loss ≤10 years.

Exclusion Criteria

Medical Conditions:

1. Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.

2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.

3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.

4. General Infection History:

   • Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
   • Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
   • Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.

5. Specific Viral Infection History:

   • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
   • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.

6. Other Medical Conditions:

   • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
   • Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.
   • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
   • Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
   • Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.

7. Adolescent participants 12 to <18 years of age without one of the following:

   • Documented evidence from a health professional of having received varicella vaccination (2 doses); or
   • Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.

8. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

   Prior/Concomitant Therapy:

9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.

   Prior/Concurrent Clinical Study Experience:

10. Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

    Diagnostic Assessments:

11. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.

12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.

    Other Exclusion Criteria:

13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ritlecitinib 100 mg	Ritlecitinib 100 mg	Randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Ritlecitinib 100 mg	Placebo - 50 mg	Randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Ritlecitinib 50 mg	Ritlecitinib 50 mg	Randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
Ritlecitinib 50 mg	Placebo - 100 mg	Randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20	Week 24	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo

Secondary Outcome Measures

Name	Time	Method
EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"	Week 24	Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Percentage of participants with absolute SALT score less than or equal to 20	Week 24 through Week 48	Percentage of participants with SALT score less than or equal to 20 for ritlecitinib 100 mg QD, ritlecitinib 50 mg responder (R)--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Change from baseline in SALT score	Baseline through Week 24	Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
US Only: Percentage of participants with absolute SALT score less than or equal to 20	Week 36	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo
Percentage of participants with absolute SALT score less than or equal to 10	Week 24 through Week 48	Percentage of participants with SALT score less than or equal to 10 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Percentage of participants with absolute SALT score equal to 0	Baseline through Week 24	Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Baseline through Week 24	Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Baseline through Week 24	Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"	Week 24 through Week 48	Percentage of participants with PGI-C response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Week 24 through Week 48	Percentage of participants with EBA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Week 24 through Week 48	Percentage of participants with ELA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Change from Week 24 in SALT score	Week 24 through Week 48	Mean absolute change from Week 24 in SALT score for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD
Percentage of participants with SALT score equal to 0	Week 24 through Week 48	Percentage of participants with SALT score equal to 0 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

Trial Locations

Locations (20)

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Southern California Clinical Research; 🇺🇸 Santa Ana, California, United States

Brett King MD, LLC; 🇺🇸 Fairfield, Connecticut, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Myrtle Beach, South Carolina, United States

Robert B. Pritt, DO, PA; 🇺🇸 Fort Myers, Florida, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

DJL Clinical Research, PLLC; 🇺🇸 Charlotte, North Carolina, United States

Bexley Dermatology Research; 🇺🇸 Bexley, Ohio, United States

Vital Prospects Clinical Research Institute, PC; 🇺🇸 Tulsa, Oklahoma, United States

Oregon Medical Research Center; 🇺🇸 Portland, Oregon, United States

Dermatology Associates of Plymouth Meeting; 🇺🇸 Plymouth Meeting, Pennsylvania, United States

Wiseman Dermatology Research Inc.; 🇨🇦 Winnipeg, Manitoba, Canada

DermEffects; 🇨🇦 London, Ontario, Canada

Lynderm Research Inc.; 🇨🇦 Markham, Ontario, Canada

JRB Research Inc.; 🇨🇦 Ottawa, Ontario, Canada

SKiN Centre for Dermatology; 🇨🇦 Peterborough, Ontario, Canada

Research Toronto; 🇨🇦 Toronto, Ontario, Canada

Centre de Recherche Saint-Louis; 🇨🇦 Sherbrooke, Quebec, Canada

Centre de Recherche Saint-Louis inc.; 🇨🇦 Quebec, Canada