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Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTP-543
CTP-543 Matching Placebo
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:

  • Definitive diagnosis of 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 SALT score ≥50, at Screening and Baseline.
  • Clinical lab results within the normal range

Exclusion Criteria:

  • Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
  • Treatment with systemic immunosuppressive medications or biologics.
  • Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CTP-543 8 mg BID

CTP-543 16 mg QD

Arm Description

Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.

Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.

Outcomes

Primary Outcome Measures

Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).

Secondary Outcome Measures

Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).
Percentage of Participants With Change in Satisfaction of Hair Coverage
Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to the Week 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.

Full Information

First Posted
January 18, 2019
Last Updated
November 15, 2022
Sponsor
Concert Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03811912
Brief Title
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Official Title
A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
November 21, 2019 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, 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
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTP-543 8 mg BID
Arm Type
Experimental
Arm Description
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
Arm Title
CTP-543 16 mg QD
Arm Type
Experimental
Arm Description
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
CTP-543 administered as 8 mg tablet.
Intervention Type
Drug
Intervention Name(s)
CTP-543 Matching Placebo
Intervention Description
Administered as tablets to aid treatment masking.
Primary Outcome Measure Information:
Title
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Description
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
Description
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Description
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Description
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score).
Time Frame
Baseline, Weeks 4, 8, 12, 16 and 20
Title
Percentage of Participants With Change in Satisfaction of Hair Coverage
Description
Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to the Week 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.
Time Frame
Baseline, Week 24
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events as a Measure of Safety
Time Frame
24 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 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. Clinical lab results within the normal range Exclusion Criteria: Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp. Treatment with systemic immunosuppressive medications or biologics. Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen E Hamilton, MS
Organizational Affiliation
Concert Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Investigative Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Investigative Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigative Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Investigative Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

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