This study is in progress, not accepting new patients

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

a study on Alopecia

Summary

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

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
    Irvine California 92697 United States
  • Marvel Clinical Research 002, LLC
    Huntington Beach California 92647 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04517864
Phase
Phase 2 Alopecia Research Study
Study Type
Interventional
Participants
About 71 people participating
Last Updated