Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
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
1 other identifier
interventional
66
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2019
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedResults Posted
Study results publicly available
April 5, 2023
CompletedApril 5, 2023
April 1, 2023
11 months
May 6, 2019
March 7, 2023
April 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
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
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Baseline, Weeks 4, 8, 12, 16 and 20
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Baseline, Weeks 8, 12 and 24
Other Outcomes (1)
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
From first dose up to 28 weeks
Study Arms (2)
CTP-543 12 mg BID
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Administered as tablets to aid treatment masking.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Colorado Center for Dermatology and Skin Surgery
Centennial, Colorado, 80111, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
Research Toronto
Toronto, Ontario, M4W 2N4, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colleen E. Hamilton
- Organization
- Concert Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 8, 2019
Study Start
May 24, 2019
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
April 5, 2023
Results First Posted
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share