This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.
This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Participants will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
149
Administered as tablets.
Administered as tablets.
University of California, Irvine
Irvine, California, United States
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, United States
Stanford University School of Medicine
Redwood City, California, United States
Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.
Time frame: Week 24
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.
Time frame: From first dose of study drug up to safety follow up at Week 28
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Kaiser Permanente Northern California
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Siperstein Dermatology Group
Boynton Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
...and 3 more locations