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Recruiting NCT07348055

A Study of GR1803 in Systemic Lupus Erythematosus

Phase I / Phase II Interventional Systemic Lupus Erthematosus Auto Immune Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GR1803 injection.
Who it may be relevant to
Registry conditions: Systemic Lupus Erthematosus, Auto Immune Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus

Overview

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

Interventions

  • Biological GR1803 injection
    step-up dosing, Dose and frequency according to the protocol

Primary outcome measures

  • incidence of adverse event [Time frame: 52 week]
Secondary outcome measures (1)
  • efficacy of GR1803 [Time frame: 52 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07348055 · GR1803-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗