Clinical trial NCT03941548: Efficacy and Tolerability Study of Two Dosing 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: 2019-05-08
Enrollment: 66
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:

* Clinical presentation compatible with 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.

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.

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% Reduction in SALT Score From Baseline
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Relative Change From Baseline in SALT Scores 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 From Baseline
timeFrame: Baseline, Weeks 8, 12 and 24
Other outcomes:
measure: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose up to 28 weeks
Locations:
city: Centennial
country: United States
facility: Colorado Center for Dermatology and Skin Surgery
state: Colorado
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
References: