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This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR2002 injection 1 | Experimental | GR2002 injection dose 1/Placebo,multiple-dose,Subcutaneous,high frequency |
|
| GR2002 injection 2 | Experimental | GR2002 injection dose 2/Placebo,multiple-dose,Subcutaneous,high frequency |
|
| GR2002 injection 3 | Experimental | GR2002 injection dose 3/Placebo,multiple-dose,Subcutaneous,high frequency |
|
| GR2002 injection 4 | Experimental | GR2002 injection dose 3/Placebo,multiple-dose,Subcutaneous,low frequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2002 injection | Biological | TSLP monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence of AEs. | Within 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters | concentration of GR2002 | Within 20 weeks |
| IGA Response | Proportion of subjects with an IGA score of 0-1 and a decrease of ≥2 points from baseline |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianzhong Zhang, PHD | Contact | 010-88325472 | rmzjz@126.com | |
| Xuewenjun Zhang, MD | Contact | 021-50805989-8324 | zhangxuewenjun@genrixbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang, PHD | Peking University People's Hospital | Principal Investigator |
| Cheng Zhou, PHD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | 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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| Within 20 weeks |
| EASI 50/75/90 Response | Proportion of subjects with ≥50%, ≥75%, and ≥90% improvement in EASI score | Within 20 weeks |
| Percentage change in BSA score | Percentage change from baseline in BSA involvement in atopic dermatitis lesions | Within 20 weeks |
| Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3 | Proportion of subjects with ≥4/3-point decrease in PP-NRS from baseline | Within 20 weeks |
| immunogenicity | Detection of anti-drug antibody(ADA) | Within 20 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |