Clinical trial

A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis

Name

RSJ10303

Description

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis. The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

Trial arms

Trial start

2019-11-06

Estimated PCD

2020-08-21

Trial end

2020-08-31

Status

Completed

Phase

Early phase I

Treatment

Drug: SHR0302

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Arms:

Active Comparator: SHR0302 dose A, Active Comparator: SHR0302 dose B, Placebo Comparator: Placebo

Size

105

Primary endpoint

The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.

At week 12

Eligibility criteria

Inclusion Criteria: * Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent * Moderate to severe atopic dermatitis * Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study Exclusion Criteria: * Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study * Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis * Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

Updated at

2023-05-09

1 organization

1 product

1 indication

Organization

Reistone Biopharma

Product

SHR0302

Indication

Atopic Dermatitis