Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM310 | Experimental | CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W) |
|
| Placebo | Placebo Comparator | Double blind treatment period : Placebo Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Drug | IL-4Rα monoclonal antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving EASI-75 at week 16 | 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). | 16 weeks |
| Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16 | 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). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | 64 weeks |
| Percent change of EASI score from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| jianzhong zhang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41257453 | Derived | Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Zhao W, Chu W, Chen B, Zhang J. Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial. Clin Transl Allergy. 2025 Nov;15(11):e70121. doi: 10.1002/clt2.70121. | |
| 40650707 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Placebo |
|
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). |
| 52 weeks |
| Percent change of NRS score from baseline | The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) | 52 weeks |
| Body surface area (BSA) of involvement of atopic dermatitis | Change from baseline in percent of BSA | 52 weeks |
| Changes from baseline in Dermatology Life Quality Index (DLQI) | 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. | 52 weeks |
| Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) | anti-drug antibody (ADA) and neutralizing antibody (Nab) | 64 weeks |
| Derived |
| Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Liang C, Qiu Y, Chen B, Zhang J. Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial. Adv Ther. 2025 Sep;42(9):4527-4539. doi: 10.1007/s12325-025-03284-7. Epub 2025 Jul 12. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |