Overview

A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

Status:
Completed
Trial end date:
2020-08-31
Target enrollment:
0
Participant gender:
All
Summary
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Reistone Biopharma Company Limited
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)