Actively Recruiting
A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2026-03-10
44
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of GR1803 injection in adults with systemic lupus erythematosus, an autoimmune disease. This clinical trial is a Phase Ib/IIa study focusing on patients with a confirmed diagnosis and a SLEDAI-2K score of 6 or higher. The study aims to better understand the treatment's impact on this condition. Participants will receive GR1803 injection using a step-up dosing schedule with doses and frequency determined by the study protocol. There are four different dosing groups in this trial, all receiving the experimental medication. The study is non-randomized and unblinded, allowing participants and researchers to know the treatment details. During the 52-week study period, participants will be closely monitored for adverse events and treatment effects. Researchers will assess safety by tracking any side effects and evaluate efficacy by measuring disease activity over time. Participants will need to comply with the treatment and undergo regular assessments to support the study's goals.
CONDITIONS
Brief Title
A Study of GR1803 in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of systemic lupus erythematosus
- SLEDAI-2K score of 6 or higher
- Written informed consent and ability to comply with protocol requirements
- Received adequate dose of glucocorticoids, antimalarials, or immunosuppressants for at least 3 months
You will not qualify if you...
- Unstable acute or chronic diseases
- Active infection
- History of malignant tumor within the past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive step-up dosing of GR1803 injection with dose and frequency according to the protocol.
Visits scheduled according to dosing protocol
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
N
Nian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here