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

NCT04517864

TerminatedPhase 2

Sponsor: Pfizer

Conditions: Alopecia Areata

Interventions: PF-06651600, Placebo

Countries: United States, Australia, Canada, Poland

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (38)
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • Boca Raton, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miramar, Florida, United States
  • Orlando, Florida, United States
  • Oviedo, Florida, United States
  • Tampa, Florida, United States
  • Skokie, Illinois, United States
  • Skokie, Illinois, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • Albuquerque, New Mexico, United States
  • Stony Brook, New York, United States
  • Raleigh, North Carolina, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • Franklin, Virginia, United States
  • Lynchburg, Virginia, United States
  • Norfolk, Virginia, United States
  • Kogarah, New South Wales, Australia
  • Box Hill, Victoria, Australia
  • East Melbourne, Victoria, Australia
  • Markham, Ontario, Canada
  • Peterborough, Ontario, Canada
  • Verdun, Quebec, Canada
  • Québec, Canada
  • + 8 more on CT.gov