Clinical trial NCT03811912: Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will 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.


Eligibility 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 Severity of Alopecia Tool (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

Primary outcomes:
measure: Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
timeFrame: Baseline, Weeks 4, 8, 12, 16 and 20
measure: Percentage of Participants With Change in Satisfaction of Hair Coverage
timeFrame: Baseline, Week 24
Other outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: 24 Weeks
Locations:
city: Irvine
country: United States
facility: Investigative Site
state: California
city: San Francisco
country: United States
facility: Investigative Site
state: California
city: New Haven
country: United States
facility: Investigative Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Investigative Site
state: Florida
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Fridley
country: United States
facility: Investigative Site
state: Minnesota
city: Portsmouth
country: United States
facility: Investigative Site
state: New Hampshire
city: Winston-Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Portland
country: United States
facility: Investigative Site
state: Oregon
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Colleen E Hamilton, MS
role: STUDY_DIRECTOR
References: