Status:
TERMINATED
PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
Lead Sponsor:
Pfizer
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04517864
Start Date
September 15 2020
End Date
May 7 2024
Last Update
July 11 2025
Active Locations (38)
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1
Marvel Clinical Research 002, LLC
Huntington Beach, California, United States, 92647
2
University of California, Irvine
Irvine, California, United States, 92697
3
Skin Care Research, LLC
Boca Raton, Florida, United States, 33486
4
Skin Care Research, LLC
Hollywood, Florida, United States, 33021