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

NCT ID: NCT03811912

Last Updated: 2022-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2019-11-21

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.

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 8 mg BID

Participants received 1 x 8 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

CTP-543 administered as 8 mg tablet.

CTP-543 Matching Placebo

Intervention Type DRUG

Administered as tablets to aid treatment masking.

CTP-543 16 mg QD

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.

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

CTP-543 administered as 8 mg tablet.

CTP-543 Matching Placebo

Intervention Type DRUG

Administered as tablets to aid treatment masking.

Interventions

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CTP-543

CTP-543 administered as 8 mg tablet.

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Concert Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colleen E Hamilton, MS

Role: STUDY_DIRECTOR

Concert Pharmaceuticals, Inc.

Locations

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Investigative Site

Irvine, California, United States

Site Status

Investigative Site

San Francisco, California, United States

Site Status

Investigative Site

New Haven, Connecticut, United States

Site Status

Investigative Site

Boynton Beach, Florida, United States

Site Status

Investigative Site

Boston, Massachusetts, United States

Site Status

Investigative Site

Boston, Massachusetts, United States

Site Status

Investigative Site

Fridley, Minnesota, United States

Site Status

Investigative Site

Portsmouth, New Hampshire, United States

Site Status

Investigative Site

Winston-Salem, North Carolina, United States

Site Status

Investigative Site

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CP543.2002

Identifier Type: -

Identifier Source: org_study_id