Clinical trial NCT04784533: A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Official title: A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 317
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 is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.


Eligibility criteria: Inclusion Criteria:

* Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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: Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
timeFrame: From Week 24 to Week 48
measure: Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
timeFrame: From Week 24 to Week 48
measure: Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
timeFrame: Week 24 of re-treatment
Secondary outcomes:
measure: Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
timeFrame: Weeks 28, 32, 36, 40, 44, and 48
measure: Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
timeFrame: Weeks 28, 32, 36, 40, 44, and 48
measure: Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Part A, Period 1: 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: Part A, Period 1: 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: Part A, Period 1: 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: Part A, Period 1: 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: Part A, Period 1: 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: Part A, Period 1: 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: Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
measure: Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
measure: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to last follow up visit (Week 76)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT Research
state: Arizona
city: Bakersfield
country: United States
facility: Kern Research, Inc.
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
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, Inc.
state: Colorado
city: New Haven
country: United States
facility: Yale University Church Street Research Unit
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
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: Clarkston
country: United States
facility: Michigan Center for Research Company, LLC
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of New Jersey
state: New Jersey
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: Raleigh
country: United States
facility: North Carolina Dermatology Associates, PLLC
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Columbus
country: United States
facility: Remington Davis
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Portland
country: United States
facility: Northwest Dermatology
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research, LLC
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: Dallas
country: United States
facility: Dermatology Treatment and Research Center, PA
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Springville
country: United States
facility: Springville Dermatology/CCT Research
state: Utah
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
Study officials:
References: