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
This Study is
No Longer Enrolling
Study B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents 12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015).
MoreChild to Adult
Prior participants from studies B7931005 and B7981015, as well as de novo participants will be eligible to participate in this study.
Have a clinical diagnosis of AA with no other etiology of hair loss 25% scalp hair loss due to AA (including AT and AU) No evidence of terminal hair regrowth within 6 months of the screening visit Current episode of hair loss 10 years (for de novo participants only) Age - 12 years and older Sex - Male or Female
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Treatment
University of Colorado Hospital
Protocol Number: 19-2839
More information available at ClinicalTrials.gov: NCT04006457
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