Alopecia Areata Clinical Study (12 yrs+)

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 Alopeica Areata

Study Description

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.

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.

Condition or Disease

Alopecia Areata

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	550
Primary Outcome Measures	1. Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Actual Study Start Date:	April 2025
Estimated Primary Completion Date:	March 2027

Eligibility Criteria

Ages Eligible for Study:	12 Years Old & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Alopecia Areata

Inclusion Criteria

Must meet the following alopecia areata criteria at both Screening and Baseline: ave a clinical diagnosis of alopecia areata with no other etiology of hair loss, ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months, Current episode of hair loss ≤10 years

Exclusion Criteria

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
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
Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria
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
History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.

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Alopecia Areata Study (12 Years+)