Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.
Interventions
BIOLOGICALCM310
Interleukin-4 receptor(IL-4Rα) monoclonal antibody
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). * Subjects who must complete the evaluation of Week 18 of the main study. * With Atopic Dermatitis.
Exclusion criteria
* Any major surgery planned during the research period. * Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period. * With any circumstance that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to week 52 | Incidence of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points | up to week 62 | Proportion of subjects with IGA 0 or 1 (on a 5-point scale, range from 0-4 point, higher scores mean a worse disease severity) and reduction ≥2 points from baseline. |
| Improvement of Numerical Rating Scale (NRS) | up to week 62 | Proportion of subjects with improvement (reduction) of pruritus NRS from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch). |
| Body surface area (BSA) of involvement of atopic dermatitis | up to week 62 | Change from baseline in percent of BSA |
| Children Dermatology Life Quality Index (CDLQI) | up to week 62 | Changes from baseline in CDLQI |
| Change from baseline in Eczema Area and Severity Index (EASI) | up to week 62 | Changes from baseline in Eczema Area and Severity Index (EASI) |
| EuroQol Five Dimensions Questionnaire (EQ-5D) | up to week 62 | Changes from baseline in EQ-5D |
| Pharmacokinetics parameters | up to week 62 | Trough concentration and exposure of CM310 |
| Immunogenicity | up to week 62 | Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab) |
| Patient-Oriented Eczema Measure (POEM) | up to week 62 | Changes from baseline in POEM |
Countries
China
Outcome results
None listed