Status:
COMPLETED
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03811912
Start Date
March 21 2019
End Date
November 21 2019
Last Update
December 9 2022
Active Locations (10)
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1
Investigative Site
Irvine, California, United States, 92697
2
Investigative Site
San Francisco, California, United States, 94118
3
Investigative Site
New Haven, Connecticut, United States, 06519
4
Investigative Site
Boynton Beach, Florida, United States, 33472