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RECRUITING

NCT06873945

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2025-04-01

Completion Date

2027-03-09

Last Updated

2025-10-01

Healthy Volunteers

Conditions

Alopecia Areata

Interventions

DRUG

Ritlecitinib 100 mg

100 mg Capsule

DRUG

Ritlecitinib 50 mg

50 mg Capsule

DRUG

Placebo - 100 mg

Capsule (to match Ritlecitinib 100 mg)

DRUG

Placebo - 50 mg

Capsule (to match Ritlecitinib 50 mg)

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.

Locations (114)

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Doc1 Healthcare Systems

Brea, California, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Southern California Clinical Research

Santa Ana, California, United States

Brett King MD, LLC

Fairfield, Connecticut, United States

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, United States

Robert B. Pritt, DO, PA

Fort Myers, Florida, United States

Solutions Through Advanced Research

Jacksonville, Florida, United States

Pediatric Skin Research

Miami, Florida, United States

Skin Research of South Florida

Miami, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Olympian Clinical Research - Tampa - Memorial Highway

Tampa, Florida, United States

Endeavor Health

Skokie, Illinois, United States

Indiana University Health University Hospital Adult Outpatient Center

Indianapolis, Indiana, United States

Indiana University School of Medicine - Indiana CTSI Clinical Research Center

Indianapolis, Indiana, United States

Sidney & Lois Eskenazi Health Center

Indianapolis, Indiana, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Callender Center for Clinical Research

Glenn Dale, Maryland, United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Apex Clinical Research Center - Canton

Canton, Ohio, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Oregon Medical Research Center

Portland, Oregon, United States

Northwest Dermatology Institute

Portland, Oregon, United States

NW Dermatology Institute

Portland, Oregon, United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Alliance for Multispecialty Research, LLC

Myrtle Beach, South Carolina, United States

Arlington Research Center

Arlington, Texas, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Center for Clinical Studies - Clear Lake

Webster, Texas, United States

AMR Clinical

Layton, Utah, United States

University of Utah

Murray, Utah, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Principle Research Solutions

Spokane, Washington, United States

CaRe Clinic

Red Deer, Alberta, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Guelph Dermatology Research

Guelph, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

Ryan Clinical Research Inc.

Newmarket, Ontario, Canada

The Centre for Clinical Trials

Oakville, 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

Montreal, Quebec, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Centre de Recherche Saint-Louis

Sherbrooke, Quebec, Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Canada

Centre de Recherche Saint-Louis inc.

Québec, Canada

China-Japan Friendship Hospital