RecruitingRecruiting
A Study of GR1803 in Systemic Lupus Erythematosus
NCT07348055 · Genrix (Shanghai) Biopharmaceutical Co., Ltd.
In plain English
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Official title
A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
About this study
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
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
Study design
Enrollment target: 44 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-02-02
Estimated completion: 2027-12-01
Last updated: 2026-03-10
Interventions
Biological: GR1803 injection
Primary outcomes
- • incidence of adverse event (52 week)
Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd. · industry
Contacts & investigators
ContactNian · contact · nianhanli@genrixbio.com · 021-50805989-08324
All locations (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China