A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ritlecitinib in Pediatric Participants 6 to Less Than 12 Years of Age With Severe Alopecia Areata - B7981027

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250283

Enrollment

225

Registered

2025-08-05

Start date

2025-09-17

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alopecia Areata

Interventions

*Drug: Ritlecitinib higher dose -Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles. -Other Names: #Active Treatment *Drug: Ritle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: *A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of >=50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months. *For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics) *Documented evidence 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 Immunoglobulin G (IgG) antibody (Ab) result) at screening.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: *Other (non-AA) types of alopecia, including any known congenital cause of AA. *Pre-existing hearing loss. *Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. *Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score >=70). *Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). *Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.

Design outcomes

Primary

Measure	Time frame
For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score <=20. [Time Frame: Week 24] -The difference in proportions of participants with the SALT <=20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score <=10. [Time Frame: Week 24] -The difference in proportions of participants with the SALT <=10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.	—

Measure

Time frame

*For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score <=20. [Time Frame: Week 24] -The difference in proportions of participants with the SALT <=20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score <=10. [Time Frame: Week 24] -The difference in proportions of participants with the SALT <=10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

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Secondary

Measure	Time frame
For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". [Time Frame: Week 24] -The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. For all countries: Change from baseline (CFB) in SALT score. [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.] -The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. For all countries: Response based on achieving absolute SALT score <=20 at all visits (except for that included as the primary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18] -The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. For all countries: Response based on achieving absolute SALT score <=10 at all visits (except for that included as the primary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18.] -The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18.] -The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib	—

Measure

Time frame

*For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". [Time Frame: Week 24] -The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For all countries: Change from baseline (CFB) in SALT score. [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.] -The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For all countries: Response based on achieving absolute SALT score <=20 at all visits (except for that included as the primary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18] -The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For all countries: Response based on achieving absolute SALT score <=10 at all visits (except for that included as the primary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18.] -The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. *For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint). [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 18.] -The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib

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Countries

Canada, China, Czechia, France, Italy, Japan, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jun 11, 2026