A Study of GR1803 in Systemic Lupus Erythematosus

Phase 2RecruitingNCT07348055

Genrix (Shanghai) Biopharmaceutical Co., Ltd.44 enrolled

Overview

to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erthematosus Auto Immune Disease

Interventions

GR1803 injectionBIOLOGICAL

step-up dosing, Dose and frequency according to the protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * comfirmed diagnosis of systemic lupus erythematosus * SLEDAI-2K≥6分 * written informed consent and ability to comply with protocol requirements * have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months Exclusion Criteria: * with unstable acute and chronic diseases * active infection * history of malignant tumor within 5 years

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

incidence of adverse event

Time frame: 52 week

Secondary Outcomes

efficacy of GR1803

clinical response of SLE

Time frame: 52 week

Central Contacts

Nian

CONTACT

021-50805989-08324 nianhanli@genrixbio.com

Data from ClinicalTrials.gov

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