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Trial record 13 of 15 for:    alopecia areata | Canada

Efficacy and Tolerability Study of Two Dosing 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03941548
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : July 2, 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : May 16, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

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
24 mg once-daily (QD)

Experimental: CTP-543 BID Dose Regimen
Oral tablet for 24 Weeks
Drug: CTP-543 BID Dose Regimen
12 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

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

Inclusion Criteria:

  • Clinical presentation compatible with alopecia areata with a history of recurrence and spontaneous remission. Individuals must have 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.

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 within 3 months of screening or during the study, or biologics within 6 months of screening or during the study.
  • Clinical lab results outside the normal range.

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): NCT03941548


Contacts
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Contact: Colleen E. Hamilton, MS 781-860-0045 AAclinicaltrial_inquiries@concertpharma.com

Locations
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United States, Colorado
Colorado Center for Dermatology and Skin Surgery Recruiting
Centennial, Colorado, United States, 80111
United States, Florida
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
United States, Indiana
The Indiana Clinical Trials Center, PC Recruiting
Plainfield, Indiana, United States, 46168
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Texas
Austin Institute for Clinical Research, Inc. Recruiting
Pflugerville, Texas, United States, 78660
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
Guelph Dermatology Research Recruiting
Guelph, Ontario, Canada, N1L 0B7
Dr Wei Jing Loo Medicine Professional Corporation Recruiting
London, Ontario, Canada, N6H 5L5
Lynderm Research Inc. Recruiting
Markham, Ontario, Canada, L3P 1X2
The Centre for Clinical Trials Recruiting
Oakville, Ontario, Canada, L6J 7W5
Research Toronto Recruiting
Toronto, Ontario, Canada, M4W 2N2
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Concert Pharmaceuticals

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03941548     History of Changes
Other Study ID Numbers: CP543.2003
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical