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This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM310 | Experimental | adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs | Up to 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI) | Incidence and rate (events per patient-year) of SAEs and AESIs | Up to 2 Years |
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit |
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Inclusion Criteria:
Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
Provide signed informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39080181 | Derived | Zhao Y, Li JY, Yang B, Ding YF, Wu LM, Zhang LT, Wang JY, Lu QJ, Zhang CL, Zhang FR, Zhu XH, Li YM, Tao XH, Diao QC, Li LF, Lu JY, Man XY, Li FQ, Xia XJ, Song JR, Jia YM, Zhang LB, Chen B, Zhang JZ. Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial. BioDrugs. 2024 Sep;38(5):681-689. doi: 10.1007/s40259-024-00668-z. Epub 2024 Jul 31. |
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| 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 |
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The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD |
| Up to 2 Years |
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit | Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)] | Up to 2 Years |
| Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD | Up to 2 Years |
| Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD | Up to 2 Years |
| Change from baseline in EASI score at each visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD | Up to 2 Years |
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to 2 Years |
| Proportion of patients with IGA reduction from baseline of ≥2 points at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to 2 Years |
| Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline | Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years |
| Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years |
| Percent change from baseline in NRS | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years |
| Body Surface Area (BSA) | Change from baseline in percent of BSA | Up to 2 Years |
| Time to first remission (achieving IGA = 0 or 1) | Up to 2 Years |
| Time to first relapse (eg, IGA >2) after remission or to not achieving remission | Up to 2 Years |
| Time to first EASI-50/75/90 | Up to 2 Years |
| Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment | Up to 2 Years |
| Number of days on topical medication (per patient-year) | Up to 2 Years |
| Changes from baseline to prespecified time points through the end of the study: 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 (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL | Up to 2 Years |
| immunogenicity | Detection of anti-drug antibody (ADA) | Up to 2 Years |
| Pharmacokinetics parameters | trough concentration of CM310 | Up to 2 Years |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |