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

Alopecia Areata Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137381
• Other study ID #: CP543.2001
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2017
• Est. completion date: July 8, 2019

Study information

• Verified date: June 2022
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• CTP-543
Administered as tablets.
• CTP-543 matching placebo
Administered as tablets.

Locations

Country	Name	City	State
United States	Siperstein Dermatology Group	Boynton Beach	Florida
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Suzanne Bruce & Associates, PA	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Yale School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Northwest Dermatology	Portland	Oregon
United States	Contour Dermatology & Cosmetic Surgery Center	Rancho Mirage	California
United States	Stanford University School of Medicine	Redwood City	California
United States	Kaiser Permanente Northern California	San Francisco	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cassella J, Hamilton C, von Hehn J, Braman V. CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata. In: Proceedings from the 28th EADV Congress; 09-13 October 2019, Madrid, Spain. D3T01.1: Late breaking news.

Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 11th World Congress Hair Research; 24-27 April 2019; Sitges, Barcelona.

Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 2019 American Academy of Dermatology Meeting; 01-05 March 2019; Washington, DC. Abstract 11291.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 24
Primary	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.	From first dose of study drug up to safety follow up at Week 28