Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

NCT04518995 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CP543.30012020-002704-40
• Study Type: interventional
• Target: 706
• Locations: 5 countries
• Sites: 72

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 of ≤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 Patient 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

EXPERIMENTAL

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

PLACEBO COMPARATOR

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 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 (72)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Kern Research, Inc.

Bakersfield, California, 93301, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Quest Dermatology Research

Northridge, California, 91324, United States

Location

Kaiser Permanente

Oakland, California, 94611, United States

Location

Kaiser Permanente South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente

San Francisco, California, 94118, United States

Location

Colorado Center for Dermatology and Skin Surgery

Centennial, Colorado, 80111, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Yale University, Church Street Research Unit

New Haven, Connecticut, 06519, United States

Location

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Forward Clinical Trials Inc.

Tampa, Florida, 33624, United States

Location

Denova Research

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Qualmedica Research LLC

Owensboro, Kentucky, 42301, United States

Location

Massachusetts General Hospital - Clinic

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, 55455, United States

Location

Skin Laser and Surgery Specialists of NJ

Hackensack, New Jersey, 07601, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Darst Dermatology

Charlotte, North Carolina, 28277, United States

Location

Dermatology Specialists of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Wake Forest University Health Sciences, Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Dermatology Associates Of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

PEAK Research

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Palmetto Clinical Trial Services

Fountain Inn, South Carolina, 29644, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Austin Institute for Clinical Research, Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

West End Dermatology Associates

Richmond, Virginia, 23233, United States

Location

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin, 53144, United States

Location

Dermatology Research Institute

Calgary, Alberta, T1Y 0B4, Canada

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

Location

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

Location

JRB Research Inc.

Ottawa, Ontario, K1H 7X3, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc. - Clinic

Montreal, Quebec, H2X 2V1, Canada

Location

Hôpital Saint-André - Chu de Bordeaux

Bordeaux, Nouvelle-Aquitaine, 33075, France

Location

Hôpital Saint-Louis - Gh de La Rochelle

La Rochelle, Nouvelle-Aquitaine, 17000, France

Location

Hôpital Hotel Dieu - Chu de Nantes

Nantes, Pays de la Loire Region, 44093, France

Location

Hôpital La Timone-Dermatologie

Marseille, 13385, France

Location

Hôpital Saint Louis, Centre de Santé Sabouraud

Paris, 75010, France

Location

Vita Longa Sp.Zo.O

Katowice, 40-748, Poland

Location

SGD S.C.

Krakow, 31-147, Poland

Location

My Clinic

Warsaw, 00-144, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

Hospital Clínico Y Provincial de Barcelona

Barcelona, 8036, Spain

Location

H. U. Ramón y Cajal

Madrid, 28034, 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: August 16, 2020
• First Posted: August 19, 2020
• Study Start: November 23, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); FR (5); US (47); CA (14); PL (4)