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A Phase II Study in Patients ...

A Phase II Study in Patients With Alopecia Areata

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2021-06-29

Brief Summary

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This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

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Detailed Description

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The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR0302 Dose#1

Group Type ACTIVE_COMPARATOR

SHR0302

Intervention Type DRUG

Oral tablets taken once daily (QD)

SHR0302 Dose#2

Group Type ACTIVE_COMPARATOR

SHR0302

Intervention Type DRUG

Oral tablets taken once daily (QD)

SHR0302 Dose#3

Group Type ACTIVE_COMPARATOR

SHR0302

Intervention Type DRUG

Oral tablets taken once daily (QD)

Placebo

Group Type PLACEBO_COMPARATOR

SHR0302

Intervention Type DRUG

Oral tablets taken once daily (QD)

Interventions

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SHR0302

Oral tablets taken once daily (QD)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent;
* Must have moderate to severe alopecia areata.

Exclusion Criteria

* Other types of alopecia or other diseases that can cause hair loss
* Other scalp diseases that could interfere with assessment of hair loss/regrowth
* Any previous use of any Janus kinase (JAK) inhibitor

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quest Dermatology Research

Northridge, California, United States

Site Status

Moore Clinical Research

Brandon, Florida, United States

Site Status

Dawes Fretzin Clinical Research

Indianapolis, Indiana, United States

Site Status

Skin Search of Rochester, Inc

Rochester, New York, United States

Site Status

Dermatologists of Southwest Ohio

Mason, Ohio, United States

Site Status

The Skin Wellness Center

Knoxville, Tennessee, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, Australia

Site Status

Novatrials

Kogarah, New South Wales, Australia

Site Status

Veracity Clinical Research

Woolloongabba, Queensland, Australia

Site Status

Skin Health Institute

Carlton, Victoria, Australia

Site Status

Sinclair Dermatology

East Melbourne, Victoria, Australia

Site Status