Tests SIM0278 in people with active lupus nephritis
Tests SIM0278 against placebo in adults with active lupus kidney inflammation.
Plain-language title generated from the registry record
Registry title: A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07393451, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Simcere Pharmaceutical Co., Ltd
- Trial code
- NCT07393451
- Record updated
- 6 February 2026
- Original description
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy.Read full original descriptionShow less
A Randomized, Double-blind, Placebo, Parallel-Controlled, Multicenter Phase 2a Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SIM0278 in Subjects With Active Lupus Nephritis
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy.
Approximately 60 subjects with active LN are planned to be enrolled and randomized 1: 1 to SIM0278 or placebo.
The study consists of 3 phases: screening, double-blind treatment, and safety follow-up.
Inclusion: Weight ≥ 40.0 kg; SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria; Subjects must be receiving or willing to initiate induction therapy for LN. Induction therapy, defined as including high-dose glucocorticoids and MMF, should be initiated within 60 days or on the same day prior to baseline.
Exclusion: Previous or current nephropathy (except LN) that, in the opinion of the investigator, may interfere with the LN assessment and interfere with the assessment of disease activity (e.g., diabetic nephropathy). The subject was unable or unwilling to provide written informed consent and/or to comply with study procedures; Previous induction therapy for MMF/MPS was considered by the investigator to have failed; Severe renal impairment: a) oliguria (defined as recorded urine volume < 400 mL/24 h), or b) end-stage renal disease (ESRD) requiring dialysis or transplantation.