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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03811912
Other study ID # CP543.2002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 21, 2019
Est. completion date November 21, 2019

Study information

Verified date November 2022
Source Concert Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
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 57
Est. completion date November 21, 2019
Est. primary completion date November 21, 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CTP-543
CTP-543 administered as 8 mg tablet.
CTP-543 Matching Placebo
Administered as tablets to aid treatment masking.

Locations

Country Name City State
United States Investigative Site Boston Massachusetts
United States Investigative Site Boston Massachusetts
United States Investigative Site Boynton Beach Florida
United States Investigative Site Fridley Minnesota
United States Investigative Site Irvine California
United States Investigative Site New Haven Connecticut
United States Investigative Site Portland Oregon
United States Investigative Site Portsmouth New Hampshire
United States Investigative Site San Francisco California
United States Investigative Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Adverse Events as a Measure of Safety 24 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% Relative 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 in SALT Scores From Baseline 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 in SALT Scores From Baseline 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 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 the Week 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, Week 24
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