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Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03137381
Recruitment Status : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 28, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE August 9, 2017
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [ Time Frame: 24 weeks ]
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2017)
  • Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [ Time Frame: 24 weeks ]
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 52 weeks ]
Change History Complete list of historical versions of study NCT03137381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Brief Summary This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic, moderate to severe alopecia areata.
Detailed Description This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Subjects will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: CTP-543
    tablets
  • Drug: Placebo
    tablets
Study Arms  ICMJE
  • Experimental: CTP-543, 4 mg
    Oral tablet, dosed twice-daily
    Intervention: Drug: CTP-543
  • Experimental: CTP-543, 8 mg
    Oral tablet, dosed twice-daily
    Intervention: Drug: CTP-543
  • Experimental: CTP-543, 12 mg
    Oral tablet, dosed twice-daily
    Intervention: Drug: CTP-543
  • Placebo Comparator: Placebo
    Oral tablet, dosed twice daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2019)
149
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2017)
100
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03137381
Other Study ID Numbers  ICMJE CP543.2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Concert Pharmaceuticals
Study Sponsor  ICMJE Concert Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ginny Braman Concert Pharmaceuticals, Inc.
PRS Account Concert Pharmaceuticals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP