A Study to Evaluate the Safety and Efficacy of GR2002 Injection in Patients With Atopic Dermatitis.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GR2002 Injection in Patients With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: GR2002 injection


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Patients need to meet Williams diagnostic criteria, have had AD for at least 1 year, and:EASI ≥16, IGA score ≥3, and AD involvement of ≥10% of BSA; Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD; Voluntary informed consent. Main Exclusion Criteria: Current malignancy or history of malignancy; History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation; Subjects may have active Mycobacterium tuberculosis infection; Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit; History of known or suspected immunosuppression; Presence of skin comorbidities that may interfere with evaluation; Suspected or confirmed allergy to the test drug (including excipients, similar drugs); History of alcohol or drug abuse within 3 months prior to screening； Pregnant or lactating women who need to breastfeed； Major surgery planned during the trial； The elution cycle of the drug of interest is not met at the baseline； Subjects of childbearing potential and partners refusing to use highly effective contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GR2002 injection 1<br>GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency | Biological: GR2002 injection<br>* TSLP monoclonal antibody<br>|
| Experimental: GR2002 injection 2<br>GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency | Biological: GR2002 injection<br>* TSLP monoclonal antibody<br>|
| Experimental: GR2002 injection 3<br>GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency | Biological: GR2002 injection<br>* TSLP monoclonal antibody<br>|
| Experimental: GR2002 injection 4<br>GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency | Biological: GR2002 injection<br>* TSLP monoclonal antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence of AEs. | Within 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TSLP