Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.
Interventions
BIOLOGICALCM310
Interleukin-4 receptor(IL-4Rα) monoclonal antibody
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
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). * With Atopic Dermatitis.
Exclusion criteria
* Not enough washing-out period for previous therapies. * Any major surgery planned during the research period. * With intestinal parasitic infection within the 6 months before screening. * With any circumstance that is not suitable to participate in this study. * Major surgeries are planned during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving EASI-75 at week 18 | Up to week 18 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of 0 (none) through 3 (severe). |
| Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline | up to week 18 | Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body surface area (BSA) of involvement of atopic dermatitis | up to week 18 | Change from baseline in percent of BSA |
| Children Dermatology Life Quality Index (CDLQI) | up to week 18 | Changes from baseline in CDLQI |
| Patient-Oriented Eczema Measure (POEM) | up to week 18 | Changes from baseline in POEM |
| EuroQol Five Dimensions Questionnaire (EQ-5D) | up to week 18 | Changes from baseline in EQ-5D |
| Percent change of Eczema Area and Severity Index (EASI) score from baseline | up to week 18 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of 0 (absent) through 3 (severe). |
| Pharmacokinetics parameters | up to week 26 | Trough concentration and exposure of CM310 |
| Pharmacodynamics | up to week 26 | Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH) |
| Immunogenicity | up to week 26 | Detection of anti-drug antibody (ADA) |
| Safety parameters | up to week 26 | Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
| Percent change of NRS score from baseline | up to week 18 | The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) |
Countries
China
Outcome results
None listed