Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

NCT04797650 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CP543.30022021-000387-30
• Study Type: interventional
• Target: 517
• Locations: 7 countries
• Sites: 63

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.

Conditions

Alopecia Areata

Keywords

Alopecia; Hair loss; Hair disease; CTP-543

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24

  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).

  Week 24

Secondary Outcomes (15)

• Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24

  Weeks 12, 16, 20, and 24

• Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20

  Weeks 4, 8, 12, 16, and 20

• Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24

  Baseline, Weeks 4, 8, 12, 16, 20, and 24

• Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24

  Weeks 12, 16, 20, and 24

• Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24

  Weeks 12, 16, 20, and 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Drug: CTP-543 matching placebo

CTP-543 8 mg BID

EXPERIMENTAL

Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.

Drug: CTP-543

CTP-543 12 mg BID

EXPERIMENTAL

Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.

Drug: CTP-543

Interventions

CTP-543 matching placebo DRUG

Administered as tablets.

Placebo

CTP-543 DRUG

Administered as tablets.

CTP-543 12 mg BID; CTP-543 8 mg BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (63)

Alliance Dermatology & Mohs Center

Phoenix, Arizona, 85032, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

University of Miami Hospital

Miami, Florida, 33124, United States

Location

Floridian Research Institute LLC

Miami, Florida, 33145, United States

Location

MetroBoston Clinical Partners, LLC

Brighton, Massachusetts, 02135, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48087, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Galen Research

Chesterfield, Missouri, 63005, United States

Location

Vivida Dermatology

Las Vegas, Nevada, 89148, United States

Location

The Dermatology Group P.C.

Verona, New Jersey, 07044, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center - Department of Dermatology

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States

Location

Oregon Medical Research

Portland, Oregon, 97223, United States

Location

Velocity Clinical Research - Providence

Warwick, Rhode Island, 02886, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37922, United States

Location

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States

Location

Elixir Research Group

Houston, Texas, 77077, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Velocity Clinical Research/Gateway

Salt Lake City, Utah, 84101, United States

Location

Velocity Clinical Research/Swinyer-Woseth Dermatology

Salt Lake City, Utah, 84117, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Care Clinic Ltd.

Red Deer, Alberta, T4N6V7, Canada

Location

Medical Arts Health Research Group

Kelowna, British Columbia, V1Y 4N7, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X1Y9, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B1A5, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W4R4, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitan

Québec, L4B1A5, Canada

Location

Centre Hospitalier Universitaire de Nice - Hôpital Archet 2

Nice, Alpes-maritimes, 06202 CEDEX 3, France

Location

Chru de Brest - Hôpital Morvan

Brest, Finestère, 29609 CEDEX, France

Location

Universitaetsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum Rechts Der Isar, Technische Universität München

Munich, Bavaria, 80802, Germany

Location

Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim - Dermatologische Studienambulanz

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Dermatologische Studienambulanz

Bochum, North Rhine-Westphalia, 44791, Germany

Location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Erlangen Hautklinik

Erlangen, 91054, Germany

Location

Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika

Pécs, Baranya, 7632, Hungary

Location

Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika

Szeged, Csongrád-csanád, 6720, Hungary

Location

Bugát Pál Kórház

Gyöngyös, Heves County, 3200, Hungary

Location

Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika

Budapest, Pest County, 1085, Hungary

Location

Wromedica I. Bielicka, A. Strzalkowska S.C.

Wroclaw, Lower Silesian Voivodeship, 50-685, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sól

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Etg Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

Warsaw, Masovian Voivodeship, 00-716, Poland

Location

Rcmed Oddzial Warszawa

Warsaw, Masovian Voivodeship, 00-892, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, Masovian Voivodeship, 02-664, Poland

Location

Etg Warszawa

Warsaw, Masovian Voivodeship, 02-793, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Etg Skierniewice

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Hospital Del Mar

Barcelona, Catalonia, 08001, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas

Madrid, 28034, Spain

Location

Hospital Doce de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28081, Spain

Location

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Hair Diseases

Condition Hierarchy (Ancestors)

Hypotrichosis; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Colleen E. Hamilton
• Organization: Concert Pharmaceuticals, Inc.

AAclinicaltrial_inquiries@concertpharma.com

781-860-0045

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: June 10, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 29, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); DE (8); PL (9); ES (8); HU (4); FR (2); CA (7)