Clinical Trials List
2020-01-09 - 2026-02-28
Phase III
Recruiting6
ICD-10L63.2
Ophiasis
ICD-10L63.8
Other alopecia areata
ICD-10L63.9
Alopecia areata, unspecified
ICD-9704.01
Alopecia areata
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
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Sponsor
Pfizer
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Donald Liu Division of Dermatology
- YIH-AN KING Division of Dermatology
- Pin-Zhir Chao Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ng Chau Yee 無
- Hua-En Lee Division of Dermatology
- 紀景琪 Division of Dermatology
- 吳明穎 Division of Dermatology
- Yu-Huei Huang 無
- Chung-Yao Hsu Division of Dermatology
- Chun-Bing Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳盈君 Division of Dermatology
- Ling-Feng Wang Division of Dermatology
- 池珮綾 Division of Dermatology
- Sheng Yiao Lin Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
To evaluate the long-term safety and tolerability of PF-06651600 in adult and adolescent participants with AA in the treatment period over time.
Secondary
To evaluate the long-term efficacy of PF-06651600 in adult and adolescent participants with AA
To evaluate the effect of PF-06651600 on patient-centered outcomes and payer relevant measures to assess treatment benefit from the patient perspective and to demonstrate value.
Inclution 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
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
Exclusion criteria for all participants:
- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit
The Estimated Number of Participants
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Taiwan
36 participants
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Global
860 participants
