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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-24

Study Completion Date

2020-04-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CTP-543 12 mg BID

Participants received 1 x 12 milligrams (mg) CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

Administered as 12 mg tablets.

CTP-543 Matching Placebo

Intervention Type DRUG

Administered as tablets to aid treatment masking.

CTP-543 24 mg QD

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

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

Administered as 12 mg tablets.

CTP-543 Matching Placebo

Intervention Type DRUG

Administered as tablets to aid treatment masking.

Interventions

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CTP-543

Administered as 12 mg tablets.

Intervention Type DRUG

CTP-543 Matching Placebo

Administered as tablets to aid treatment masking.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No