Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : January 21, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543 QD Dose Regimen Drug: CTP-543 BID Dose Regimen Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CTP-543 QD Dose Regimen
Oral tablet for 24 Weeks
Drug: CTP-543 QD Dose Regimen
16 mg once-daily (QD)

Experimental: CTP-543 BID Dose Regimen
Oral tablet for 24 Weeks
Drug: CTP-543 BID Dose Regimen
8 mg twice-daily (BID)




Primary Outcome Measures :
  1. Relative change in Severity of Alopecia Tool (SALT) score for each dose regimen [ Time Frame: 24 Weeks ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811912


Locations
Layout table for location information
United States, California
Investigative Site
Irvine, California, United States, 92697
Investigative Site
San Francisco, California, United States, 94118
United States, Connecticut
Investigative Site
New Haven, Connecticut, United States, 06519
United States, Florida
Investigative Site
Boynton Beach, Florida, United States, 33472
United States, Massachusetts
Investigative Site
Boston, Massachusetts, United States, 02114
Investigative Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
Investigative Site
Fridley, Minnesota, United States, 55432
United States, New Hampshire
Investigative Site
Portsmouth, New Hampshire, United States, 03801
United States, North Carolina
Investigative Site
Winston-Salem, North Carolina, United States, 27104
United States, Oregon
Investigative Site
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Colleen E Hamilton, MS Concert Pharmaceuticals, Inc.

Layout table for additonal information
Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03811912     History of Changes
Other Study ID Numbers: CP543.2002
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical