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NCT03898479 Clinical Trial

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

Alopecia Areata Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03898479
Other study ID # CP543.5001
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date April 4, 2019
Est. completion date February 2025

Study information
Verified date May 2024
Source Concert Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date February 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CTP-543
Twice daily dosing

Locations
Country Name City State
Canada SimcoDerm Medical and Surgical Dermatology Center Barrie Ontario
Canada Dermatology Research Institute Calgary Alberta
Canada Kirk Barber Research Calgary Alberta
Canada Kingsway Clinical Research Etobicoke Ontario
Canada Guelph Dermatology Research Guelph Ontario
Canada Medical Arts Health Research Group Kelowna British Columbia
Canada DermEffects London Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada Innovaderm Research Inc. Montreal Quebec
Canada Dr. S. K. Siddha Medicine Professional Corporation Newmarket Ontario
Canada The Centre for Clinical Trials Oakville Ontario
Canada JRB research Inc. Ottawa Ontario
Canada Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) Québec
Canada Care Clinic Red Deer Alberta
Canada Centre for Dermatology Richmond Hill Ontario
Canada Enverus Medical Research Surrey British Columbia
Canada Research Toronto Toronto Ontario
Canada Alliance Clinical Trials Waterloo Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
United States Kern Research Inc. Bakersfield California
United States Bexley Dermatology Research Bexley Ohio
United States Total Skin and Beauty Dermatology Center Birmingham Alabama
United States Skin Care Research, LLC Boca Raton Florida
United States ASR, LLC Boise Idaho
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Hope Clinical Research Canoga Park California
United States Colorado Center for Dermatology, PLLC d/b/a CODerm Research Centennial Colorado
United States Clinical Research Center of the Carolinas Charleston South Carolina
United States Darst Dermatology Charlotte North Carolina
United States Dermatology Specialists of Charlotte Charlotte North Carolina
United States University of Virginia Health System Charlottesville Virginia
United States Denova Research Chicago Illinois
United States Clarkston Skin Research Clarkston Michigan
United States Remington-Davis, Inc. Columbus Ohio
United States Dermatology Treatment and Research Center - Dallas Dallas Texas
United States Colorado Medical Research Center Denver Colorado
United States Velocity Clinical Research-Providence East Greenwich Rhode Island
United States California Dermatology & Clinical Research Institute Encinitas California
United States Johnson Dermatology Fort Smith Arkansas
United States Palmetto Clinical Trial Services Fountain Inn South Carolina
United States Minnesota Clinical Study Center Fridley Minnesota
United States North Texas Center for Clinical Research Frisco Texas
United States Skin Laser and Surgery Specialists of NJ Hackensack New Jersey
United States Skin Care Research, LLC Hollywood Florida
United States Suzanne Bruce and Associates, PA Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States University of California, Irvine Irvine California
United States Clinical Investigation Specialists, Inc. Kenosha Wisconsin
United States Vivida Dermatology Las Vegas Nevada
United States Dermatology Research Associates Los Angeles California
United States DS Research Louisville Kentucky
United States Floridian Research Institute, LLC Miami Florida
United States University of Miami Hospital Miami Florida
United States University of Minnesota Department of Dermatology Minneapolis Minnesota
United States DS Research New Albany Indiana
United States Yale University Church Street Research Unit New Haven Connecticut
United States Icahn School of Medicine at Mount Sinai New York New York
United States Sadick Research Group New York New York
United States Quest Dermatology Research Northridge California
United States Kaiser Permanente Northern California - Oakland Oakland California
United States Qualmedica Research Owensboro Kentucky
United States Palmtree Clinical Research, Inc. Palm Springs California
United States Austin Institute for Clinical Research, Inc. Pflugerville Texas
United States Hospital of the University of Pennsylvania Dept of Dermatology Philadelphia Pennsylvania
United States Alliance Dermatology & MOHS Center Phoenix Arizona
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania
United States NW Dermatology Institute Portland Oregon
United States Oregon Medical Research Center Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States North Carolina Dermatology Associates, PLLC Raleigh North Carolina
United States Stanford University School of Medicine - Medical Dermatology Clinic Redwood City California
United States West End Dermatology Associates Richmond Virginia
United States UR Dermatology at College Town Rochester New York
United States Northwest Arkansas Clinical Trials Center, PLLC Rogers Arkansas
United States Kaiser Permanente South Sacramento Sacramento California
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Progressive Clinical Research San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Kaiser Permanente Clinical Trials Unit San Francisco California
United States Center for Dermatology and Plastic Surgery/CCT Research Scottsdale Arizona
United States Lenus Research & Medical Group, LLC Sweetwater Florida
United States Clinical Research Trials of Florida, Inc. Tampa Florida
United States ForCare Clinical Research Tampa Florida
United States Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma
United States Peak Research - Pennsylvania Upper Saint Clair Pennsylvania
United States Schweiger Dermatology, P.C. Verona New Jersey
United States Jordan Valley Dermatology West Jordan Utah
United States Wake Forest University Health Sciences, Department of Dermatology Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Concert Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety 276 weeks
Primary Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) 276 weeks
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Terminated NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A