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

NCT ID: NCT06175143

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-10-31

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.

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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TSLP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GR2002 injection 1

GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency

Group Type EXPERIMENTAL

GR2002 injection

Intervention Type BIOLOGICAL

TSLP monoclonal antibody

GR2002 injection 2

GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency

Group Type EXPERIMENTAL

GR2002 injection

Intervention Type BIOLOGICAL

TSLP monoclonal antibody

GR2002 injection 3

GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency

Group Type EXPERIMENTAL

GR2002 injection

Intervention Type BIOLOGICAL

TSLP monoclonal antibody

GR2002 injection 4

GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency

Group Type EXPERIMENTAL

GR2002 injection

Intervention Type BIOLOGICAL

TSLP monoclonal antibody

Interventions

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GR2002 injection

TSLP monoclonal antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianzhong Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Cheng Zhou, PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Jianzhong Zhang, PHD

Role: CONTACT

Phone: 010-88325472

Email: [email protected]

Xuewenjun Zhang, MD

Role: CONTACT

Phone: 021-50805989-8324

Email: [email protected]

Facility Contacts

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Jianzhong Zhang, PHD

Role: primary

Other Identifiers

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GR2002-002

Identifier Type: -

Identifier Source: org_study_id