Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941548
• Other study ID #: CP543.2003
• Status: Completed
• Phase: Phase 2
• Start date: May 24, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: April 2023
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical presentation compatible with 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.

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 within 3 months of screening or during the study, or biologics within 6 months of screening or during the study.

• Clinical lab results outside the normal range.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• CTP-543
Administered as 12 mg tablets.
• CTP-543 Matching Placebo
Administered as tablets to aid treatment masking.

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Guelph Dermatology Research	Guelph	Ontario
Canada	Dr Wei Jing Loo Medicine Professional Corporation	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	The Centre for Clinical Trials	Oakville	Ontario
Canada	Research Toronto	Toronto	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Colorado Center for Dermatology and Skin Surgery	Centennial	Colorado
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	From first dose up to 28 weeks
Primary	Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score 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). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).	Baseline, Week 24
Secondary	Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline	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). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary	Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 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). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary	Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20	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). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).	Baseline, Weeks 4, 8, 12, 16 and 20
Secondary	Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline	Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to Weeks 8, 12 and 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.	Baseline, Weeks 8, 12 and 24