ong-Term PF-06651600 for the Treatment of Alopecia Areata

Phase 4

Completed

• Conditions: alopecia areata (AA)

• Registration Number: JPRN-jRCT2080224919
• Lead Sponsor: Pfizer R&D Japan G.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.

De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

No evidence of terminal scalp hair regrowth within 6 months (de novo only)
Current episode of terminal scalp hair loss <=10 years (de novo only)

Exclusion Criteria

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Number of subjects reporting treatment-emergent adverse events,<br>Number of subjects reporting serious adverse events,<br>Number of subjects reporting adverse events leading to discontinuation,<br>Number of subjects with clinically significant abnormalities in vital signs,<br>Number of subjects with clinically significant abnormalities in clinical laboratory values <br>[Time Frame: Baseline through Month 36]<br><br>Vaccine sub-study: Percentage of subjects with a tetanus booster response<br> [Time Frame: Vaccine sub-study Month 1]