TerminatedPhase 2

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

Stopped: For business reasons

United States71 participantsStarted 2020-09-15

Plain-language 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).

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Trial details

NCT IDNCT04517864

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-04

Results submitted2022-10-17

View on ClinicalTrials.gov More Alopecia Areata trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9

Timeframe: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)