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A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTP-543
Placebo
Sponsored by
Concert Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring CTP-543

Eligibility Criteria

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

Inclusion Criteria:

  • Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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 SALT score ≥50, at Screening and Baseline.
  • Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • Center for Dermatology and Plastic Surgery/CCT Research
  • Kern Research, Inc.
  • Hope Clinical Research
  • California Dermatology & Clinical Research Institute
  • University of California, Irvine
  • Quest Dermatology Research
  • Kaiser Permanente
  • Palmtree Clinical Research, Inc.
  • Kaiser Permanente
  • Colorado Center for Dermatology and Skin Surgery
  • Colorado Medical Research Center, Inc.
  • Yale University Church Street Research Unit
  • Skin Care Research, LLC
  • Skin Care Research, LLC
  • DeNova Research
  • The Indiana Clinical Trials Center, PC
  • DS Research
  • Michigan Center for Research Company, LLC
  • University of Minnesota Department of Dermatology
  • Minnesota Clinical Study Center
  • Skin Specialists, PC
  • Skin Laser and Surgery Specialists of New Jersey
  • Darst Dermatology
  • Dermatology Specialists of Charlotte
  • North Carolina Dermatology Associates, PLLC
  • Bexley Dermatology Research
  • Remington Davis
  • Vital Prospects Clinical Research Institute, PC
  • Northwest Dermatology
  • Dermatology Associates of Plymouth Meeting
  • PEAK Research, LLC
  • Rhode Island Hospital
  • Clinical Research Center of the Carolinas
  • Dermatology Treatment and Research Center, PA
  • Austin Institute for Clinical Research
  • Austin Institute for Clinical Research, Inc.
  • Springville Dermatology/CCT Research
  • West End Dermatology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Part A, Period 1 - Low dose

Part A, Period 1 - High dose

Part A, Period 2 - Dose reduction from low dose

Part A, Period 2 - Drug discontinuation from low dose

Part A, Period 2 - Dose reduction from high dose

Part A, Period 2 - Drug discontinuation from high dose

Part B - Low dose

Part B - High dose

Arm Description

8 mg BID CTP-543 for 24 weeks

12 mg BID CTP-543 for 24 weeks

Dose reduction for a maximum of 24 weeks for those previously receiving 8 mg BID

Placebo for a maximum of 24 weeks for those previously receiving 8 mg BID

Dose reduction for a maximum of 24 weeks for those previously receiving 12 mg BID

Placebo for a maximum of 24 weeks for those previously receiving 12 mg BID

8 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria

12 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria

Outcomes

Primary Outcome Measures

Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Proportion of patients by dose group achieving restoration of regrowth
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

Secondary Outcome Measures

Percentage of patients achieving loss of maintenance criteria following dose reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of patients achieving loss of maintenance criteria following drug discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
Part A, Period 1: Percentage of patients achieving an absolute SALT score ≤20
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Part A, Period 1: Relative change in SALT scores from Baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
The Clinician Global Impression of Improvement (CGI-I) is a questionnaire that asks the clinician to evaluate the improvement or worsening of the patient's alopecia areata as compared to the start of the study.
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
The Patient Global Impression of Improvement (PGI-I) is a self-administered questionnaire that asks the patient to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study.
Part A, Period 1: Change from Baseline in the CGI-S
The Clinician Global Impression of Severity (CGI-S) is a questionnaire that asks the clinician to evaluate the severity of the patient's alopecia areata at the time of assessment.
Part A, Period 1: Change from Baseline in the PGI-S
The Patient Global Impression of Severity (PGI-S) is a self-administered questionnaire that asks the patient to evaluate the severity of their alopecia areata at the time of assessment.
Part A, Period 1: Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response.
Part A, Period 1: Percentage of patients achieving the restoration of regrowth
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Part A, Period 1: Relative change in SALT scores from Part B Baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Number of Participants with Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

Full Information

First Posted
March 3, 2021
Last Updated
May 31, 2023
Sponsor
Concert Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04784533
Brief Title
A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Official Title
A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a two part, double-blind, randomized, multicenter study to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with 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
Keywords
CTP-543

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A, Period 1 - Low dose
Arm Type
Experimental
Arm Description
8 mg BID CTP-543 for 24 weeks
Arm Title
Part A, Period 1 - High dose
Arm Type
Experimental
Arm Description
12 mg BID CTP-543 for 24 weeks
Arm Title
Part A, Period 2 - Dose reduction from low dose
Arm Type
Experimental
Arm Description
Dose reduction for a maximum of 24 weeks for those previously receiving 8 mg BID
Arm Title
Part A, Period 2 - Drug discontinuation from low dose
Arm Type
Placebo Comparator
Arm Description
Placebo for a maximum of 24 weeks for those previously receiving 8 mg BID
Arm Title
Part A, Period 2 - Dose reduction from high dose
Arm Type
Experimental
Arm Description
Dose reduction for a maximum of 24 weeks for those previously receiving 12 mg BID
Arm Title
Part A, Period 2 - Drug discontinuation from high dose
Arm Type
Placebo Comparator
Arm Description
Placebo for a maximum of 24 weeks for those previously receiving 12 mg BID
Arm Title
Part B - Low dose
Arm Type
Experimental
Arm Description
8 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria
Arm Title
Part B - High dose
Arm Type
Experimental
Arm Description
12 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
Oral dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral dosing
Primary Outcome Measure Information:
Title
Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
24 weeks
Title
Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
24 weeks
Title
Proportion of patients by dose group achieving restoration of regrowth
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients achieving loss of maintenance criteria following dose reduction
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 4, 8, 12, 16, and 20
Title
Percentage of patients achieving loss of maintenance criteria following drug discontinuation
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 4, 8, 12, 16, and 20
Title
Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale
Description
SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Percentage of patients achieving an absolute SALT score ≤20
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 8, 12, 16, 20, and 24
Title
Part A, Period 1: Relative change in SALT scores from Baseline
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
Description
The Clinician Global Impression of Improvement (CGI-I) is a questionnaire that asks the clinician to evaluate the improvement or worsening of the patient's alopecia areata as compared to the start of the study.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
Description
The Patient Global Impression of Improvement (PGI-I) is a self-administered questionnaire that asks the patient to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Change from Baseline in the CGI-S
Description
The Clinician Global Impression of Severity (CGI-S) is a questionnaire that asks the clinician to evaluate the severity of the patient's alopecia areata at the time of assessment.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Change from Baseline in the PGI-S
Description
The Patient Global Impression of Severity (PGI-S) is a self-administered questionnaire that asks the patient to evaluate the severity of their alopecia areata at the time of assessment.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale
Description
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response.
Time Frame
Weeks 12, 16, 20, and 24
Title
Part A, Period 1: Percentage of patients achieving the restoration of regrowth
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 4, 8, 12, 16, and 20 of re-treatment
Title
Part A, Period 1: Relative change in SALT scores from Part B Baseline
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Title
Number of Participants with Adverse Events (AEs)
Description
An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Time Frame
72 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: Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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 SALT score ≥50, at Screening and Baseline. Willing to comply with the study visits and requirements of the study protocol. Exclusion Criteria: 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.
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
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
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
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Kaiser Permanente
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
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Colorado Center for Dermatology and Skin Surgery
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Colorado Medical Research Center, Inc.
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
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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
Michigan Center for Research Company, LLC
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Skin Laser and Surgery Specialists of New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
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
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Remington Davis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Northwest Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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, LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
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
Dermatology Treatment and Research Center, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Austin Institute for Clinical Research
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
Springville Dermatology/CCT Research
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
West End Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

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