PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA

• Status: Active, not recruiting
• Trial end date: 2023-05-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to Alopecia Areata (AA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.

• At least 25% hair loss due to alopecia areata

• Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)

• Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy

• Signed informed consent

• Stable regimen for other medications before and during the study

Exclusion Criteria:

• Other significant medical conditions

• Occupational or recreational noise exposure

• History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy

• HbA1c > or = 7.5% at Screening

• Recurrent or disseminated Herpes Zoster

• Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months

• Active or latent (insufficiently treated) Hepatitis

• Active or latent (insufficiently treated) TB

• Concomitant medications associated with peripheral neurologic or hearing loss

• Protocol specific laboratory abnormalities