Efficacy and Tolerability Study of Two Dose 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: NCT03811912
• Other study ID #: CP543.2002
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

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