Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
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
1 other identifier
interventional
149
1 country
13
Brief Summary
This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedStudy Start
First participant enrolled
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedResults Posted
Study results publicly available
July 19, 2022
CompletedJuly 19, 2022
June 1, 2022
1.9 years
April 28, 2017
June 27, 2022
June 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.
Week 24
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.
From first dose of study drug up to safety follow up at Week 28
Study Arms (4)
Cohort 1: CTP-543 4 mg BID
EXPERIMENTALParticipants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.
Cohort 2: CTP-543 8 mg BID
EXPERIMENTALParticipants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.
Cohort 3: CTP-543 12 mg BID
EXPERIMENTALParticipants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.
Combined Placebo
PLACEBO COMPARATORParticipants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
Interventions
Administered as tablets.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of California, Irvine
Irvine, California, 92697, United States
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, 92270, United States
Stanford University School of Medicine
Redwood City, California, 94064, United States
Kaiser Permanente Northern California
San Francisco, California, 94118, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Siperstein Dermatology Group
Boynton Beach, Florida, 33472, United States
Northwestern University
Chicago, Illinois, 60611, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Northwest Dermatology
Portland, Oregon, 97210, United States
Suzanne Bruce & Associates, PA
Houston, Texas, 77056, United States
Related Publications (3)
Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 2019 American Academy of Dermatology Meeting; 01-05 March 2019; Washington, DC. Abstract 11291.
BACKGROUNDCassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 11th World Congress Hair Research; 24-27 April 2019; Sitges, Barcelona.
BACKGROUNDCassella J, Hamilton C, von Hehn J, Braman V. CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata. In: Proceedings from the 28th EADV Congress; 09-13 October 2019, Madrid, Spain. D3T01.1: Late breaking news.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colleen E. Hamilton
- Organization
- Concert Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Colleen E. Hamilton
Concert Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 2, 2017
Study Start
August 9, 2017
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
July 19, 2022
Results First Posted
July 19, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share