A Phase II Study in Patients With Alopecia Areata

A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: SHR0302

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology and Skin Cancer Centre
    • Kogarah, New South Wales, Australia, 2289
      • Novatrials
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Tongren Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400011
      • Chongqing Traditional Chinese Medicine Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • The Dermatology Hospital of Nanfang Medical University
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • The Dermatology Hospital of Nanfang Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Jiangsu
    • Nanjin, Jiangsu, China, 210029
      • Jiangsu Province People's Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai skin disease hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300120
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
• United States
  • California
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
  • Florida
    • Brandon, Florida, United States, 33511
      • MOORE Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc
  • Ohio
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwest Ohio
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
  • Texas
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: SHR0302; Oral tablets taken once daily (QD)
Active Comparator: SHR0302 Dose#1	Drug: SHR0302; Oral tablets taken once daily (QD)
Active Comparator: SHR0302 Dose#2	Drug: SHR0302; Oral tablets taken once daily (QD)
Active Comparator: SHR0302 Dose#3	Drug: SHR0302; Oral tablets taken once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in Severity of Alopecia Tool (SALT) score	Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss	week 24

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: RSJ10521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No