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

Phase 2

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: CTP-543; Drug: CTP-543 Matching Placebo

• Registration Number: NCT03941548
• Lead Sponsor: Concert Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-05-24
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Disposition First Submitted: 2021-03-09
• Results First Submitted: 2023-03-07
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Results First Posted: 2023-04-05
• Disposition First Posted: 2023-04-05
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTP-543 12 mg BID	CTP-543	Participants received 1 x 12 milligrams (mg) CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
CTP-543 12 mg BID	CTP-543 Matching Placebo	Participants received 1 x 12 milligrams (mg) CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
CTP-543 24 mg QD	CTP-543	Participants received 24 mg (2 x 12 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
CTP-543 24 mg QD	CTP-543 Matching Placebo	Participants received 24 mg (2 x 12 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24	Baseline, 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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline	Baseline, 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). 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.
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24	Baseline, 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).
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20	Baseline, 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).
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline	Baseline, Weeks 8, 12 and 24	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.

Trial Locations

Locations (12)

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, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Lynderm Research Inc.; 🇨🇦 Markham, Ontario, Canada

Research Toronto; 🇨🇦 Toronto, Ontario, Canada

Colorado Center for Dermatology and Skin Surgery; 🇺🇸 Centennial, Colorado, United States

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

The Centre for Clinical Trials; 🇨🇦 Oakville, Ontario, Canada

Innovaderm Research Inc.; 🇨🇦 Montreal, Quebec, Canada