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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175143
• Other study ID #: GR2002-002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2023
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: Jianzhong Zhang, PHD
• Phone: 010-88325472
• Email: rmzjz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• GR2002 injection
TSLP monoclonal antibody

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Incidence of AEs.	Within 20 weeks
Secondary	Pharmacokinetics parameters	concentration of GR2002	Within 20 weeks
Secondary	IGA Response	Proportion of subjects with an IGA score of 0-1 and a decrease of =2 points from baseline	Within 20 weeks
Secondary	EASI 50/75/90 Response	Proportion of subjects with =50%, =75%, and =90% improvement in EASI score	Within 20 weeks
Secondary	Percentage change in BSA score	Percentage change from baseline in BSA involvement in atopic dermatitis lesions	Within 20 weeks
Secondary	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
Secondary	immunogenicity	Detection of anti-drug antibody(ADA)	Within 20 weeks