Moderate-to-severe Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
Interventions
BIOLOGICALCM326
CM326 injection
OTHERPlacebo
Placebo
Sponsors
Keymed Biosciences 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
* With confirmed Atopic Dermatitis (AD) at the screening. * Age ≥ 18 years and ≤ 75 years, male or female. * Have the ability to understand the nature of the study and voluntarily sign the informed consent. * Be able to communicate well with investigators and follow up protocol requirements.
Exclusion criteria
* Not enough washing-out period for previous therapy. * Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline. * Major surgery is planned during the study period. * Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16 | at week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD |
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16 | at week 16 | IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe) |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed