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| Name | Class |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY |
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This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002.
The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort.
Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 4ml SC | Placebo Comparator | Participants with AD will receive Placebo 4ml SC |
|
| IBI3002 300mg SC | Experimental | Participants with AD will receive IBI3002 300mg SC |
|
| IBI3002 600mg SC | Experimental | Participants with AD will receive IBI3002 600mg SC |
|
| Placebo 2ml SC | Placebo Comparator | Participants with AD will receive Placebo 2ml SC |
|
| Placebo 1ml SC | Placebo Comparator | Participants with AD will receive Placebo 1ml SC |
|
| IBI3002 150mg SC | Experimental | Participants with AD will receive IBI3002 150mg SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3002 | Drug | Participants with AD will receive IBI3002 at the corresponding dose and dosing interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of multiple doses of IBI3002 in Atopic Dermatitis patients. | The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with AD after multiple doses of IBI3002; | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PK parameters of IBI3002 in participants with AD; | PK parameters include, the maximum concentration (Cmax), after multiple doses. | Baseline to Week 20 |
| To evaluate the PK parameters of IBI3002 in participants with AD; |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wensheng Zang | Contact | 15210342569 | wensheng.zang@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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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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| Placebo | Drug | Participants with AD will receive placebo at the corresponding volume and dosing interval. |
|
PK parameters include, the maximum concentration (Tmax), after multiple doses.
| Baseline to Week 20 |
| To evaluate the PK parameters of IBI3002 in participants with AD; | PK parameters include, the maximum concentration (AUC), after multiple doses. | Baseline to Week 20 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |