- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518995
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (THRIVE-AA1)
April 7, 2023 updated by: Concert Pharmaceuticals
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
706
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2G 1B1
- Kirk Barber Research
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Calgary, Alberta, Canada, T1Y 0B4
- Dermatology Research Institute
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Center
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Guelph, Ontario, Canada, N1L 0B7
- Guelph Dermatology Research
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London, Ontario, Canada, N6H 5L5
- Dr Wei Jing Loo Medicine Professional Corporation
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Markham, Ontario, Canada, L3P 1X3
- Lynderm Research Inc.
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Newmarket, Ontario, Canada, L3Y 5G8
- Dr. S. K. Siddha Medicine Professional Corporation
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Oakville, Ontario, Canada, L6J 7W5
- The Centre for Clinical Trials
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Ottawa, Ontario, Canada, K1H 7X3
- JRB research Inc.
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Toronto, Ontario, Canada, M4W 2N4
- Research Toronto
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Waterloo, Ontario, Canada, N2J 1C4
- K. Papp Clinical Research Inc.
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc. - Clinic
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Marseille, France, 13385
- Hôpital La Timone-Dermatologie
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Paris, France, 75010
- Hôpital Saint Louis, Centre de Santé Sabouraud
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Nouvelle-aquitaine
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Bordeaux, Nouvelle-aquitaine, France, 33075
- Hôpital Saint-André - Chu de Bordeaux
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La Rochelle, Nouvelle-aquitaine, France, 17000
- Hôpital Saint-Louis - Gh de La Rochelle
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PAYS DE LA Loire
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Nantes, PAYS DE LA Loire, France, 44093
- Hôpital Hotel Dieu - Chu de Nantes
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Katowice, Poland, 40-748
- Vita Longa Sp.Zo.O
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Krakow, Poland, 31-147
- SGD S.C.
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Warsaw, Poland, 02-962
- Royalderm Agnieszka Nawrocka
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Warsaw, Poland, 00-144
- My clinic
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Barcelona, Spain, 8036
- Hospital Clínico y Provincial de Barcelona
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Madrid, Spain, 28034
- H. U. Ramón y Cajal
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Alabama
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Birmingham, Alabama, United States, 35205
- Total Skin and Beauty Dermatology Center
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California
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Bakersfield, California, United States, 93301
- Kern Research, Inc.
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Encinitas, California, United States, 92024
- California Dermatology & Clinical Research Institute
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Irvine, California, United States, 92697
- UC Irvine Dermatology Clinical Research Center
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Northridge, California, United States, 91324
- Quest Dermatology Research
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Oakland, California, United States, 94611
- Kaiser Permanente
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Sacramento, California, United States, 95823
- Kaiser Permanente South Sacramento
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San Francisco, California, United States, 94118
- Kaiser Permanente
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Colorado
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Centennial, Colorado, United States, 80111
- Colorado Center for Dermatology and Skin Surgery
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Denver, Colorado, United States, 80210
- Colorado Medical Research Center
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University, Church Street Research Unit
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Florida
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Sweetwater, Florida, United States, 33172
- Lenus Research & Medical Group, LLC
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Tampa, Florida, United States, 33607
- Clinical Research Trials of Florida, Inc.
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Tampa, Florida, United States, 33624
- Forward Clinical Trials Inc.
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Illinois
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Chicago, Illinois, United States, 60611
- DeNova Research
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital, Department of Dermatology
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Indiana
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Indianapolis, Indiana, United States, 46250
- Dawes Fretzin Clinical Research Group, LLC
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New Albany, Indiana, United States, 47150
- Ds Research
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Plainfield, Indiana, United States, 46168
- The Indiana Clinical Trials Center, PC
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Kentucky
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Louisville, Kentucky, United States, 40241
- Ds Research
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Owensboro, Kentucky, United States, 42301
- Qualmedica Research LLC
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital - Clinic
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Michigan
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Clarkston, Michigan, United States, 48346
- Clarkston Skin Research
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Department of Dermatology
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Skin Laser and Surgery Specialists of NJ
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New York
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New York, New York, United States, 10075
- Sadick Research Group
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Darst Dermatology
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Charlotte, North Carolina, United States, 28277
- Dermatology Specialists of Charlotte
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences, Department of Dermatology
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Ohio
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Bexley, Ohio, United States, 43209
- Bexley Dermatology Research
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Vital Prospects Clinical Research Institute, P.C.
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Oregon
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Portland, Oregon, United States, 97210
- Northwest Dermatology Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Plymouth Meeting, Pennsylvania, United States, 19462
- Dermatology Associates of Plymouth Meeting
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Upper Saint Clair, Pennsylvania, United States, 15241
- PEAK Research
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29407
- Clinical Research Center of the Carolinas
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Fountain Inn, South Carolina, United States, 29644
- Palmetto Clinical Trial Services
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Texas
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Bellaire, Texas, United States, 77401
- Bellaire Dermatology Associates
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Dallas, Texas, United States, 75230
- Dermatology Treatment and Research Center
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Houston, Texas, United States, 77056
- Austin Institute for Clinical Research, Inc.
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Pflugerville, Texas, United States, 78660
- Austin Institute for Clinical Research, Inc.
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San Antonio, Texas, United States, 78229
- Dermatology Clinical Research Center of San Antonio
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Virginia
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Richmond, Virginia, United States, 23233
- West End Dermatology Associates
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Wisconsin
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Kenosha, Wisconsin, United States, 53144
- Clinical Investigation Specialists, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
- Willing to comply with the study visits and requirements of the study protocol.
Exclusion Criteria:
- Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
- 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.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Placebo
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
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Administered as tablets.
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Experimental: CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
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Administered as tablets.
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Placebo Comparator: CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
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Administered as tablets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24
Time Frame: Week 24
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SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
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Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Time Frame: Weeks 12, 16, 20, and 24
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SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment.
The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.
Responders were defined as participants with responses of "satisfied" or "very satisfied".
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Weeks 12, 16, 20, and 24
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Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Time Frame: Weeks 4, 8, 12, 16, and 20
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SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
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Weeks 4, 8, 12, 16, and 20
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Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Time Frame: Weeks 12, 16, 20, and 24
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The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale.
Responses range from 1 (very much worse) to 7 (very much improved).
Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
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Weeks 12, 16, 20, and 24
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Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Time Frame: Weeks 12, 16, 20, and 24
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The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale.
Responses range from 1 (very much worse) to 7 (very much improved).
Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
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Weeks 12, 16, 20, and 24
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Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Time Frame: Baseline, Weeks 12, 16, 20, and 24
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The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment.
The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss.
Higher scores indicate more hair loss.
A negative change from baseline indicates less hair loss.
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Baseline, Weeks 12, 16, 20, and 24
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Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Time Frame: Baseline, Weeks 12, 16, 20, and 24
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The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment.
Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss.
Higher scores indicate more hair loss.
A negative change from baseline indicates less hair loss.
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Baseline, Weeks 12, 16, 20, and 24
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Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
Time Frame: Baseline, Weeks 12, and 24
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SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
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Baseline, Weeks 12, and 24
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Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Time Frame: Baseline, Weeks 12, and 24
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BETA is a clinician-rated scale that assesses the total eyebrow hair present.
The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0 = no eyebrow, 1 = minimal eyebrow, 2 = moderate eyebrow, 3 = normal eyebrow.
The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows.
A positive change from baseline indicates less hair loss of eyebrows.
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Baseline, Weeks 12, and 24
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Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Time Frame: Baseline, Weeks 12, and 24
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BELA is a clinician-rated scale that assesses the total eyelash hair present.
The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes).
The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes.
A positive change from baseline indicates less hair loss of eyelashes.
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Baseline, Weeks 12, and 24
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Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Time Frame: Baseline, Weeks 12, 16, 20, and 24
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SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment.
The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.
Higher scores indicate the greater hair dissatisfaction.
A negative change from baseline indicate the greater hair satisfaction.
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Baseline, Weeks 12, 16, 20, and 24
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Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Time Frame: Weeks 12, 16, 20, and 24
|
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment.
The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.
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Weeks 12, 16, 20, and 24
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Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Time Frame: Baseline, Weeks 12, 16, 20, and 24
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The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response.
The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied.
Higher scores indicate the greater dissatisfaction on hair quality.
A negative change from baseline indicate the greater satisfaction on hair quality.
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Baseline, Weeks 12, 16, 20, and 24
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Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Time Frame: Baseline and Week 24
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HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants.
The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression.
Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression.
A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression.
Higher scores indicate greater severity.
A negative change from baseline indicates less severity.
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Baseline and Week 24
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Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
Time Frame: Week 24
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SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
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Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2020
Primary Completion (Actual)
April 19, 2022
Study Completion (Actual)
April 19, 2022
Study Registration Dates
First Submitted
August 16, 2020
First Submitted That Met QC Criteria
August 16, 2020
First Posted (Actual)
August 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP543.3001
- 2020-002704-40 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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