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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: GR2002 injection

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jianzhong Zhang, PHD; Phone Number: 010-88325472; Email: rmzjz@126.com
• Study Contact Backup: Name: Xuewenjun Zhang, MD; Phone Number: 021-50805989-8324; Email: zhangxuewenjun@genrixbio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking university People's Hospital
      • Contact: Jianzhong Zhang, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jianzhong Zhang, PHD, Peking university People's Hospital; Principal Investigator: Cheng Zhou, PHD, Peking university People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: TSLP
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: GR2002-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No