Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA

Keywords

Alopecia Areata alopecia totalis alopecia universalis hair loss alopecia JAK ritlecitinib PF-06651600 double-blind placebo-controlled phase 2a

Eligibility

You can join if…

Open to people ages 18-50

  • 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 CAN'T join 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

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Marvel Clinical Research 002, LLC accepting new patients
    Huntington Beach California 92647 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04517864
Phase
Phase 2
Study Type
Interventional
Last Updated