Clinical trial NCT03898479: Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Official title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Alopecia Areata
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.


Eligibility criteria: Inclusion Criteria:

* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
* Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 332 weeks
measure: Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
timeFrame: 332 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT Research
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
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: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Northern California - Oakland
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Redwood City
country: United States
facility: Stanford University School of Medicine - Medical Dermatology Clinic
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Clinical Trials Unit
state: California
city: Centennial
country: United States
facility: Colorado Center for Dermatology, PLLC d/b/a CODerm Research
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: 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: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute, LLC
state: Florida
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: ForCare Clinical Research
state: Florida
city: Boise
country: United States
facility: ASR, LLC
state: Idaho
city: Chicago
country: United States
facility: Denova Research
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
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
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: Clinton Township
country: United States
facility: Clinical Research Institute of Michigan
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: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NJ
state: New Jersey
city: Verona
country: United States
facility: Schweiger Dermatology, P.C.
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Rochester
country: United States
facility: UR Dermatology at College Town
state: New York
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Dermatology Associates, PLLC
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: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: NW Dermatology Institute
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania Dept of Dermatology
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 - Pennsylvania
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
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: Dallas
country: United States
facility: Dermatology Treatment and Research Center - Dallas
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
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: Red Deer
country: Canada
facility: Care Clinic
state: Alberta
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
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: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: DermEffects
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: Richmond Hill
country: Canada
facility: Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Study officials:
References: