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Completed

NCT Number: NCT04346316

A Phase II Study in 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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novatrials, Kogarah, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR0302

Drug

Oral tablets taken once daily (QD)

Primary outcomes

  1. Percentage change from baseline in Severity of Alopecia Tool (SALT) score

    Time frame: week 24

    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss

Sponsors and collaborators

Lead sponsor

Reistone Biopharma Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2020
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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