PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA (Allegro2a)

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: PF-06651600

Study type: Interventional

Funder types: Industry

Identifiers

NCT04517864

B7981037

2020-001509-21 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 71 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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71 participants in 2 patient groups

Treatment Arm: PF-06651600

Experimental group

Description:

ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Treatment:

Drug: PF-06651600

Control Arm (Placebo) followed by active therapy extension

Other group

Description:

matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Treatment:

Drug: Placebo