Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    330
  • sponsor
    Reistone Biopharma Company Limited
Updated on 15 May 2021

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

Description

This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.

Details
Condition Eczema, Eczema (Atopic Dermatitis - Pediatric), ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Dermatitis, Hand Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment Core Treatment Active Experimental: SHR0302 Dose#1, Core Treatment Active Experimental: SHR0302 Dose#2, Core Treatment Placebo Comparator: Placebo, Extension Treatment Active Experimental: SHR0302 Dose#1, Extension Treatment Active Experimental: SHR0302 Dose#2
Clinical Study IdentifierNCT04875169
SponsorReistone Biopharma Company Limited
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects must be at least at 12 and 75 years of age and body weight 40 kg
Subject has a diagnosis of atopic dermatitis for at least 1 year
Meets all of the following disease activity criteria: BSA 10% of AD involvement. EASI
IGA 3. WI-NRS 4
Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period)

Exclusion Criteria

Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Have received certain treatments that are contraindicated
Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment
Other active non-AD inflammatory skin diseases or conditions affecting skin
Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma)
Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Subject has a previously received systemic JAK inhibitors
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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