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Long-Term PF-06651600 for the Treatment of Alopecia Areata
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Pfizer
 
Acronym KP IRB No.
ALLEGRO-LT 1444507
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adults and Adolescents with Clinical diagnosis of Alopecia Areata.
 
Purpose
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.
 
Detailed Description
Number of subjects reporting treatment-emergent adverse events. Time Frame: Baseline through 2 years (24 months). Number of subjects reporting serious adverse events and adverse events. Time Frame: Baseline through 2 years (24 months). Number of subjects with clinically significant abnormalities in vital signs. Time Frame: Baseline through 2 years (24 months). Number of subjects with clinically significant abnormalities in clinical laboratory values. Time Frame: Baseline through 2 years (24 months).
 
Gender Age Limit
Male & Female
 
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
  • >/=25% hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
  • No evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss
 
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: Other types of diseases that can cause hair loss or that could interfere with assessment of hair loss/regrowth
  • Participants with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
  • 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

 
Keywords and/or Specific Medical Conditions
  • Alopecia
  • Hypotrichosis
  • Alopecia Areata
  • Patchy hair loss
  • Alopecia totalis
  • Pathological Conditions, Anatomical
  • Alopecia universalis
  • Skin Diseases
  • Hair Diseases
  • Dermatology
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Dermatology


Principal Investigator:
Paradi Mirmirani, MD
Contact Information:
- Comprehensive Clinical Research Unit KPNC
-415-833-3485
-Catherine.Vowles@kp.org
-San Francisco Medical Center


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