NCT07393451Not yet recruitingPhase 2
A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 31 Mar 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Diseases
- Lupus (SLE)
- NCT number
- NCT07393451
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 31 Mar 2026 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.