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Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With 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: NCT03811912
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE March 21, 2019
Actual Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
Relative change in Severity of Alopecia Tool (SALT) score for each dose regimen [ Time Frame: 24 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
Relative change in SALT score for each dose regimen [ Time Frame: 24 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 18, 2019)
Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 Weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Official Title  ICMJE 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
Brief Summary A randomized, multi-center study to 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: CTP-543 QD Dose Regimen
    16 mg once-daily (QD)
  • Drug: CTP-543 BID Dose Regimen
    8 mg twice-daily (BID)
Study Arms  ICMJE
  • Experimental: CTP-543 QD Dose Regimen
    Oral tablet for 24 Weeks
    Intervention: Drug: CTP-543 QD Dose Regimen
  • Experimental: CTP-543 BID Dose Regimen
    Oral tablet for 24 Weeks
    Intervention: Drug: CTP-543 BID Dose Regimen
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019)
57
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
60
Actual Study Completion Date  ICMJE November 21, 2019
Actual Primary Completion Date November 21, 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 NCT03811912
Other Study ID Numbers  ICMJE CP543.2002
Has Data Monitoring Committee No
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: Undecided
Responsible Party Concert Pharmaceuticals
Study Sponsor  ICMJE Concert Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Colleen E Hamilton, MS Concert Pharmaceuticals, Inc.
PRS Account Concert Pharmaceuticals
Verification Date November 2020

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