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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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).

Key facts

Study ID

NCT04517864

Run by

Pfizer

People needed

71

Starts

2020-09-15

Expected to finish

2024-05-07

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marvel Clinical Research 002, LLC — Huntington Beach, California, United States
• University of California, Irvine — Irvine, California, United States
• Skin Care Research, LLC — Boca Raton, Florida, United States
• Skin Care Research, LLC — Hollywood, Florida, United States
• Kendall Adkisson, MD - Intracoastal Dermatology — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Y&L Advance Health Care Inc., d/b/a Elite Clinical Research — Miami, Florida, United States
• BRCR Medical Center Inc — Miramar, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Orlando, Florida, United States
• Orlando Dermatology & Skin Cancer Surgery Center — Oviedo, Florida, United States
• USF Health Morsani Center For Advanced Healthcare — Tampa, Florida, United States
• NorthShore University HealthSystem Dermatology Clinical Trials Unit — Skokie, Illinois, United States
• NorthShore University HealthSystem Dermatology Clinic — Skokie, Illinois, United States
• Washington University School of Medicine-Dermatology — St Louis, Missouri, United States
• University of New Mexico Department of Dermatology — Albuquerque, New Mexico, United States
• University of New Mexico Clinical & Translational Sciences Center — Albuquerque, New Mexico, United States
• Stony Brook Dermatology — Stony Brook, New York, United States
• M3 Wake Research, Inc. — Raleigh, North Carolina, United States
• Tekton Research, Inc. — Austin, Texas, United States
• Center for Clinical Studies, LTD. LLP — Houston, Texas, United States
• Summit Clinical Research, LLC — Franklin, Virginia, United States
• The Education & Research Foundation, Inc. — Lynchburg, Virginia, United States
• Virginia Dermatology and Skin Cancer Center — Norfolk, Virginia, United States
• Premier Specialists Pty Ltd — Kogarah, New South Wales, Australia
• Eastern Health - Box Hill Hospital — Box Hill, Victoria, Australia

Full record on ClinicalTrials.gov

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