Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata

Phase 2

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: CTP-543; Drug: CTP-543 matching placebo

• Registration Number: NCT03137381
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.

Detailed Description

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 Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-02
• Study Start: 2017-08-09
• Primary Completion: 2019-07-08
• Study Completion: 2019-07-08
• Disposition First Submitted: 2020-07-02
• Disposition First Submitted QC: 2020-07-02
• Disposition First Posted: 2020-07-07
• Status Verified: 2022-06
• Results First Submitted: 2022-06-27
• Results First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Results First Posted: 2022-07-19
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
• Clinical lab results within the normal range

Exclusion Criteria

• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
• Treatment with systemic immunosuppressive medications or biologics.
• Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: CTP-543 4 mg BID	CTP-543	Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.
Cohort 2: CTP-543 8 mg BID	CTP-543	Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.
Cohort 3: CTP-543 12 mg BID	CTP-543	Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.
Combined Placebo	CTP-543 matching placebo	Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24	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.
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)	From first dose of study drug up to safety follow up at Week 28	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.

Trial Locations

Locations (13)

University of California, Irvine; 🇺🇸 Irvine, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Suzanne Bruce & Associates, PA; 🇺🇸 Houston, Texas, United States

Contour Dermatology & Cosmetic Surgery Center; 🇺🇸 Rancho Mirage, California, United States

Siperstein Dermatology Group; 🇺🇸 Boynton Beach, Florida, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Icahn School of Medicine at Mt. Sinai; 🇺🇸 New York, New York, United States

Stanford University School of Medicine; 🇺🇸 Redwood City, California, United States

Kaiser Permanente Northern California; 🇺🇸 San Francisco, California, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Northwest Dermatology; 🇺🇸 Portland, Oregon, United States