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

Phase 1

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: GR2002 injection

• Registration Number: NCT06175143
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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;
2. Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD;
3. Voluntary informed consent.

Main

Exclusion Criteria

1. Current malignancy or history of malignancy;
2. History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
3. Subjects may have active Mycobacterium tuberculosis infection;
4. Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit;
5. History of known or suspected immunosuppression;
6. Presence of skin comorbidities that may interfere with evaluation;
7. Suspected or confirmed allergy to the test drug (including excipients, similar drugs);
8. History of alcohol or drug abuse within 3 months prior to screening；
9. Pregnant or lactating women who need to breastfeed；
10. Major surgery planned during the trial；
11. The elution cycle of the drug of interest is not met at the baseline；
12. Subjects of childbearing potential and partners refusing to use highly effective contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GR2002 injection 1	GR2002 injection	GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency
GR2002 injection 2	GR2002 injection	GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency
GR2002 injection 4	GR2002 injection	GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency
GR2002 injection 3	GR2002 injection	GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Within 20 weeks	Incidence of AEs.

Secondary Outcome Measures

Name	Time	Method
IGA Response	Within 20 weeks	Proportion of subjects with an IGA score of 0-1 and a decrease of ≥2 points from baseline
EASI 50/75/90 Response	Within 20 weeks	Proportion of subjects with ≥50%, ≥75%, and ≥90% improvement in EASI score
immunogenicity	Within 20 weeks	Detection of anti-drug antibody(ADA)
Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3	Within 20 weeks	Proportion of subjects with ≥4/3-point decrease in PP-NRS from baseline
Pharmacokinetics parameters	Within 20 weeks	concentration of GR2002
Percentage change in BSA score	Within 20 weeks	Percentage change from baseline in BSA involvement in atopic dermatitis lesions

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China