A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis
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: SIM0278 injection.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 18 years — 75 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 →
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Official title
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
Overview
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.
Interventions
- Drug SIM0278 injection
Placebo
Primary outcome measures
- Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52 [Time frame: At Week 52]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
- 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.
- Previous induction therapy for MMF/MPS was considered by the investigator to have failed.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07393451 · SIM0278-202