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

Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 site in 1 country40 target enrollmentDecember 2023

ConditionsAtopic Dermatitis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Adverse events (AEs)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2023

End Date

October 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

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；

Outcomes

Primary Outcomes

Adverse events (AEs)

Time Frame: Within 20 weeks

Incidence of AEs.

Secondary Outcomes

IGA Response(Within 20 weeks)
EASI 50/75/90 Response(Within 20 weeks)
immunogenicity(Within 20 weeks)
Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3(Within 20 weeks)
Pharmacokinetics parameters(Within 20 weeks)
Percentage change in BSA score(Within 20 weeks)