B7981094 - 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519370-40-00

Acronym

B7981094

Enrollment

Registered

2025-06-06

Start date

2025-07-16

Completion date

Unknown

Last updated

2025-11-06

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

Conditions

Alopecia areata

Brief summary

SALT ≤20 response at Week 24

Detailed description

SALT ≤20 response at Week 24, PGI-C response, defined as a score of “moderately improved” or “greatly improved” at Week 24, CFB in SALT score at Week 24

Interventions

DRUG50 MG

DRUG100 MG

DRUGRitlecitinib tosilate

DRUGRitlecitinib Tosilate

DRUGPLACEBO FOR PF-06651600-15 CAPSULE

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
SALT ≤20 response at Week 24	—

Secondary

Measure	Time frame
SALT ≤20 response at Week 24, PGI-C response, defined as a score of “moderately improved” or “greatly improved” at Week 24, CFB in SALT score at Week 24	—

Countries

Czechia, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026