Phase 2
N=105
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04162899 ↗Enrolled (actual)
105
Serious AEs
2.9%
Results posted
May 2023
Primary outcome: Primary: The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. — 9; 19; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Drug: SHR0302 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reistone Biopharma Company Limited
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. |
9; 19; 2 | — |
| SECONDARY Percentage of Czema Area and Severity Index (EASI) Change. |
— | — |
| SECONDARY Percentage of Subjects Achieving Investigator's Global Score (IGA) Response |
— | — |
| SECONDARY Percent of Pruritus Numerical Rating Scale (NRS) Change |
— | — |
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)
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)
Data sourced from ClinicalTrials.gov (NCT04162899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.