Trial intelligence / Profile preview

Long-Term Extension Study of Ritlecitinib in Severe Alopecia Areata

NCT07029828Phase 3

Key facts

Status
Recruiting
Start
Sep 2025
Primary completion
Jun 2030
Countries
9
Sponsor
Pfizer
Modality
Small Molecules
Conditions
alopecia areata
01

Overview

Phase 3, randomised, double-blind trial of ritlecitinib tosilate in alopecia areata (2 arms), sponsored by Pfizer. Primary endpoints: Incidence of treatment-emergent adverse events up to 3 years and Incidence of Serious Adverse Events and AEs leading to permanent discontinuation up to 3 years. Started Sep 2025; status: recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Ritlecitinib higher dose

    Participants receive 1 ritlecitinib higher dose capsule QD and 1 placebo lower dose capsule QD orally for up to 3 years.

  • Ritlecitinib lower dose

    Participants receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for up to 3 years.

03

Who it enrols

Participants with severe alopecia areata who completed previous ritlecitinib studies B7981027 or B7981031.

04

Endpoints

Primary

  • Incidence of treatment-emergent adverse events

  • Incidence of Serious Adverse Events and AEs leading to permanent discontinuation

Secondary

  • Proportion of participants achieving absolute Severity of Alopecia Tool score ≤10

  • Proportion of participants achieving absolute Severity of Alopecia Tool score ≤20

  • Change from baseline in Severity of Alopecia Tool score

  • Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment

  • Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment

  • Proportion of participants achieving Patient Global Impression of Change response

  • Change from baseline in PROMIS Parent Proxy Anxiety Symptoms T-score

  • Change from baseline in Behavior Rating Inventory of Executive Function T-scores

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