Dermatitis, Atopic, Eczema, Atopic
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Interventions
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female adults ages 18 to 75 years old when signing the informed consent. * AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit. * Moderate to Severe Atopic Dermatitis. * Recent history of inadequate response to treatment with topical medications.
Exclusion criteria
* Participation in a prior 611 clinical study. * Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months. * Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study. * Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study. * Evidence of active acute or chronic hepatitis. * History of malignancy within 5 years before the screening visit or currently. * Pregnant or breastfeeding women, or women planning to become pregnant. * Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score) | Baseline to Week 16 |
| Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16. | Baseline to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 | Baseline to Week 16 |
Countries
China
Outcome results
None listed