Clinical trial NCT04518995: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia
Hair loss
Hair disease
CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
timeFrame: Weeks 4, 8, 12, 16, and 20
measure: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
timeFrame: Baseline, Weeks 12, and 24
measure: Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
timeFrame: Baseline, Weeks 12, 16, 20, and 24
measure: Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Bakersfield
country: United States
facility: Kern Research, Inc.
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Irvine
country: United States
facility: UC Irvine Dermatology Clinical Research Center
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Centennial
country: United States
facility: Colorado Center for Dermatology and Skin Surgery
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: New Haven
country: United States
facility: Yale University, Church Street Research Unit
state: Connecticut
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials Inc.
state: Florida
city: Chicago
country: United States
facility: Denova Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital, Department of Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: DS Research
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research LLC
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital - Clinic
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NJ
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Department of Dermatology
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Dermatology Institute
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Dermatology Associates Of Plymouth Meeting
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc. - Clinic
state: Quebec
city: Bordeaux
country: France
facility: Hôpital Saint-André - Chu de Bordeaux
state: Nouvelle-aquitaine
city: La Rochelle
country: France
facility: Hôpital Saint-Louis - Gh de La Rochelle
state: Nouvelle-aquitaine
city: Nantes
country: France
facility: Hôpital Hotel Dieu - Chu de Nantes
state: PAYS DE LA Loire
city: Marseille
country: France
facility: Hôpital La Timone-Dermatologie
city: Paris
country: France
facility: Hôpital Saint Louis, Centre de Santé Sabouraud
city: Katowice
country: Poland
facility: Vita Longa Sp.Zo.O
city: Krakow
country: Poland
facility: SGD S.C.
city: Warsaw
country: Poland
facility: My Clinic
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Barcelona
country: Spain
facility: Hospital Clínico Y Provincial de Barcelona
city: Madrid
country: Spain
facility: H. U. Ramón y Cajal
Study officials:
References: