A Study to Evaluate the Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784533
• Other study ID #: CP543.2004
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2024
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two part, double-blind, randomized, multicenter study to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• 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 of scalp hair loss 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.

• Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

• Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.

• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.

• Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.

• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.

• Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• CTP-543
Oral dosing
• Placebo
Oral dosing

Locations

Country	Name	City	State
United States	Kern Research, Inc.	Bakersfield	California
United States	Bexley Dermatology Research	Bexley	Ohio
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Skin Care Research, LLC	Boca Raton	Florida
United States	Hope Clinical Research	Canoga Park	California
United States	Colorado Center for Dermatology and Skin Surgery	Centennial	Colorado
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Darst Dermatology	Charlotte	North Carolina
United States	Dermatology Specialists of Charlotte	Charlotte	North Carolina
United States	DeNova Research	Chicago	Illinois
United States	Michigan Center for Research Company, LLC	Clarkston	Michigan
United States	Remington Davis	Columbus	Ohio
United States	Dermatology Treatment and Research Center, PA	Dallas	Texas
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Skin Laser and Surgery Specialists of New Jersey	Hackensack	New Jersey
United States	Skin Care Research, LLC	Hollywood	Florida
United States	Austin Institute for Clinical Research	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	DS Research	Louisville	Kentucky
United States	University of Minnesota Department of Dermatology	Minneapolis	Minnesota
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Yale University Church Street Research Unit	New Haven	Connecticut
United States	Quest Dermatology Research	Northridge	California
United States	Kaiser Permanente	Oakland	California
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Palmtree Clinical Research, Inc.	Palm Springs	California
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Dermatology Associates of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Northwest Dermatology	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	North Carolina Dermatology Associates, PLLC	Raleigh	North Carolina
United States	West End Dermatology Associates	Richmond	Virginia
United States	Kaiser Permanente	San Francisco	California
United States	Center for Dermatology and Plastic Surgery/CCT Research	Scottsdale	Arizona
United States	Springville Dermatology/CCT Research	Springville	Utah
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma
United States	PEAK Research, LLC	Upper Saint Clair	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	24 weeks
Primary	Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	24 weeks
Primary	Proportion of patients by dose group achieving restoration of regrowth	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	24 weeks
Secondary	Percentage of patients achieving loss of maintenance criteria following dose reduction	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, and 20
Secondary	Percentage of patients achieving loss of maintenance criteria following drug discontinuation	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, and 20
Secondary	Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale	SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Percentage of patients achieving an absolute SALT score =20	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 8, 12, 16, 20, and 24
Secondary	Part A, Period 1: Relative change in SALT scores from Baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, 20, and 24
Secondary	Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I	The Clinician Global Impression of Improvement (CGI-I) is a questionnaire that asks the clinician to evaluate the improvement or worsening of the patient's alopecia areata as compared to the start of the study.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I	The Patient Global Impression of Improvement (PGI-I) is a self-administered questionnaire that asks the patient to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Change from Baseline in the CGI-S	The Clinician Global Impression of Severity (CGI-S) is a questionnaire that asks the clinician to evaluate the severity of the patient's alopecia areata at the time of assessment.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Change from Baseline in the PGI-S	The Patient Global Impression of Severity (PGI-S) is a self-administered questionnaire that asks the patient to evaluate the severity of their alopecia areata at the time of assessment.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale	The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response.	Weeks 12, 16, 20, and 24
Secondary	Part A, Period 1: Percentage of patients achieving the restoration of regrowth	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, and 20 of re-treatment
Secondary	Part A, Period 1: Relative change in SALT scores from Part B Baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Secondary	Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention	72 weeks