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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 105
- Locations
- 23
- Primary Endpoint
- The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Active Comparator: SHR0302 dose A
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.
Intervention: Drug: SHR0302 (Drug)
Active Comparator: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.
Intervention: Drug: SHR0302 (Drug)
Placebo Comparator: Placebo
Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.
Intervention: Drug: SHR0302 (Drug)
Outcomes
Primary Outcomes
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
Time Frame: At week 12
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.
Secondary Outcomes
- Percent of Pruritus Numerical Rating Scale (NRS) Change(Up to week 12)
- Percentage of Subjects Achieving Investigator's Global Score (IGA) Response(Up to week 8)
- Percentage of Czema Area and Severity Index (EASI) Change.(Up to week 12)