Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

Concert Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: CTP-543 Matching Placebo; Drug: CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811912

CP543.2002

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups

CTP-543 8 mg BID

Experimental group

Description:

Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.

Treatment:

Drug: CTP-543 Matching Placebo

Drug: CTP-543

CTP-543 16 mg QD

Experimental group

Description:

Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.

Treatment:

Drug: CTP-543 Matching Placebo

Drug: CTP-543