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
Not provided
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized 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 75mg arm | Experimental | 75mg for 3 doses, every 2 weeks, SC |
|
| CM310 150mg arm | Experimental | 150mg for 3 doses, every 2 weeks, SC |
|
| CM310 300mg arm | Experimental | 300mg for 3 doses, every 2 weeks, SC |
|
| CM310 600(1st)+300mg(2nd,3rd) arm | Experimental | 600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC |
|
| placebo arm | Placebo Comparator | placebo for 3 doses, every 2 weeks, SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Drug | IL-4Rα monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing) | Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Peak concentration (Cmax) | Peak concentration (Cmax) | Baseline to Week 12 |
| Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Xiangya Hospital of Central South University | Changsha | Hunan | China | |||
| Wuxi Second Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833140 | Derived | Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
| Baseline to Week 12 |
| Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t) | Area under the plasma concentration-time curve from 0 to t (AUC0-t) | Baseline to Week 12 |
| Pharmacokinetics parameter: Clearance rate (CL/F) | Clearance rate (CL/F) | Baseline to Week 12 |
| Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC) | Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS) | Baseline to Week 12 |
| Pharmacodynamics parameters: Blood eosinophil count (EOS) | Blood eosinophil count (EOS) | Baseline to Week 12 |
| Pharmacodynamics parameters: Total IgE level | Total IgE level | Baseline to Week 12 |
| Immunogenicity: Proportion of subjects with anti-drug antibody (ADA) | Proportion of Participants with anti-drug antibody (ADA) | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with IGA 0 or 1 | Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1 | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points | Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points | Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with EASI-50 | Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline) | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with EASI-75 | Proportion of subjects with EASI-75 (≥75 percent improvement from baseline) | Baseline to Week 12 |
| Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline | Proportion of subjects with improvement (reduction) of pruritus Numerical Rating Scale(NRS) from baseline; The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Baseline to Week 12 |
| Wuxi |
| Jiangsu |
| China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Peking University People's Hospital | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| Shanghai Skin Disease Hospital | Shanghai | China |