search
Back to results

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

Primary Purpose

Alopecia Areata

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CTP-543
Sponsored by
Concert Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin and Beauty Dermatology Center
  • Alliance Dermatology & MOHS Center
  • Center for Dermatology and Plastic Surgery/CCT Research
  • Johnson Dermatology
  • Northwest Arkansas Clinical Trials Center, PLLC
  • Kern Research Inc.
  • Hope Clinical Research
  • California Dermatology & Clinical Research Institute
  • University of California, Irvine
  • Dermatology Research Associates
  • Quest Dermatology Research
  • Kaiser Permanente Northern California - Oakland
  • Palmtree Clinical Research, Inc.
  • Stanford University School of Medicine - Medical Dermatology Clinic
  • Kaiser Permanente South Sacramento
  • Kaiser Permanente Clinical Trials Unit
  • Colorado Center for Dermatology, PLLC d/b/a CODerm Research
  • Colorado Medical Research Center
  • Yale University Church Street Research Unit
  • Skin Care Research, LLC
  • Skin Care Research, LLC
  • University of Miami Hospital
  • Floridian Research Institute, LLC
  • Lenus Research & Medical Group, LLC
  • Clinical Research Trials of Florida, Inc.
  • ForCare Clinical Research
  • ASR, LLC
  • Denova Research
  • Dawes Fretzin Clinical Research Group, LLC
  • DS Research
  • The Indiana Clinical Trials Center, PC
  • DS Research
  • Qualmedica Research
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Clarkston Skin Research
  • Minnesota Clinical Study Center
  • University of Minnesota Department of Dermatology
  • Vivida Dermatology
  • Skin Laser and Surgery Specialists of NJ
  • The Dermatology Group, P.C.
  • Icahn School of Medicine at Mount Sinai
  • Sadick Research Group
  • UR Dermatology at College Town
  • Darst Dermatology
  • Dermatology Specialists of Charlotte
  • North Carolina Dermatology Associates, PLLC
  • Wake Forest University Health Sciences, Department of Dermatology
  • Bexley Dermatology Research
  • Remington-Davis, Inc.
  • Vital Prospects Clinical Research Institute, P.C.
  • NW Dermatology Institute
  • Oregon Medical Research Center
  • Hospital of the University of Pennsylvania Dept of Dermatology
  • Dermatology Associates of Plymouth Meeting
  • Peak Research - Pennsylvania
  • Velocity Clinical Research-Providence
  • Rhode Island Hospital
  • Clinical Research Center of the Carolinas
  • Palmetto Clinical Trial Services
  • Dermatology Treatment and Research Center - Dallas
  • North Texas Center for Clinical Research
  • Suzanne Bruce and Associates, PA
  • Austin Institute for Clinical Research, Inc.
  • Progressive Clinical Research
  • Texas Dermatology and Laser Specialists
  • Dermatology Clinical Research Center of San Antonio
  • Jordan Valley Dermatology
  • University of Virginia Health System
  • West End Dermatology Associates
  • Clinical Investigation Specialists, Inc.
  • Dermatology Research Institute
  • Kirk Barber Research
  • Care Clinic
  • Medical Arts Health Research Group
  • Enverus Medical Research
  • Wiseman Dermatology Research Inc.
  • SimcoDerm Medical and Surgical Dermatology Center
  • Kingsway Clinical Research
  • Guelph Dermatology Research
  • DermEffects
  • Lynderm Research Inc.
  • Dr. S. K. Siddha Medicine Professional Corporation
  • The Centre for Clinical Trials
  • JRB research Inc.
  • Centre for Dermatology
  • Research Toronto
  • Alliance Clinical Trials
  • Innovaderm Research Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTP-543

Arm Description

Patients who previously completed a qualifying CTP-543 clinical trial

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
September 28, 2023
Sponsor
Concert Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT03898479
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CTP-543
Arm Type
Experimental
Arm Description
Patients who previously completed a qualifying CTP-543 clinical trial
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
Twice daily dosing
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
276 weeks
Title
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Time Frame
276 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alliance Dermatology & MOHS Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Center for Dermatology and Plastic Surgery/CCT Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center, PLLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Kern Research Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Kaiser Permanente Northern California - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Palmtree Clinical Research, Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Stanford University School of Medicine - Medical Dermatology Clinic
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Clinical Trials Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Colorado Center for Dermatology, PLLC d/b/a CODerm Research
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Yale University Church Street Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Skin Care Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Skin Care Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Floridian Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Lenus Research & Medical Group, LLC
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
ASR, LLC
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Denova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
DS Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Qualmedica Research
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Skin Laser and Surgery Specialists of NJ
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Dermatology Group, P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
UR Dermatology at College Town
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Darst Dermatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Dermatology Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
North Carolina Dermatology Associates, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Wake Forest University Health Sciences, Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
NW Dermatology Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Hospital of the University of Pennsylvania Dept of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Dermatology Associates of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Peak Research - Pennsylvania
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Velocity Clinical Research-Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Palmetto Clinical Trial Services
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Dermatology Treatment and Research Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Jordan Valley Dermatology
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
West End Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 0B4
Country
Canada
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Care Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
Guelph Dermatology Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1L 0B7
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
Dr. S. K. Siddha Medicine Professional Corporation
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
The Centre for Clinical Trials
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
JRB research Inc.
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7X3
Country
Canada
Facility Name
Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
Alliance Clinical Trials
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
City
Québec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs