Back to Results

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

Study category: Skin

Is this Study for You?

Let's Get Started!

Description

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).

Details
Age

Child to Adult

Eligibility

Prior participants from studies B7931005 and B7981015, as well as de novo participants will be eligible to participate in this study.

Detailed Eligibility: 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

Phase

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.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Cory Dunnick

Cory Dunnick

Study ID

Protocol Number: 19-2839

ClinicalTrials.gov: NCT04006457

Categories

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers