Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.
Detailed description
The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.
Interventions
DRUGCM310
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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
Exclusion criteria
* Not enough washing-out period for previous therapy. * Concurrent disease/status which may potentially affect the efficacy/safety judgement. * Organ dysfunction. * pregnancy. * Other.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving EASI-75 at week 16 | 16 weeks | Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 16. 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). |
| Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16 | 16 weeks | 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 16. 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 |
|---|---|---|
| Percent change of NRS score from baseline | 52 weeks | The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) |
| Body surface area (BSA) of involvement of atopic dermatitis | 52 weeks | Change from baseline in percent of BSA |
| Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | 64 weeks | Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
| Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | 64 weeks | anti-drug antibody (ADA) and neutralizing antibody (Nab) |
| Changes from baseline in Dermatology Life Quality Index (DLQI) | 52 weeks | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life. |
| Percent change of EASI score from baseline | 52 weeks | 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). |
Countries
China
Outcome results
None listed