NCT07393451
Not yet recruiting
Phase 2
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
Simcere Pharmaceutical Co., Ltd1 site in 1 country60 target enrollmentStarted: March 31, 2026Last updated:
InterventionsSIM0278 injection
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Test group
Experimental
Cohort 1- Test group
Intervention: SIM0278 injection (Drug)
Control group
Experimental
Cohort 2- Control group
Intervention: SIM0278 injection (Drug)
Outcomes
Primary Outcomes
Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52
Time Frame: At Week 52
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With AtherosclerosisNCT07303777Atom Therapeutics Co., Ltd200
Recruiting
Not Applicable
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal SurgeryNCT07311369Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.40
Not yet recruiting
Not Applicable
Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic CancerNCT07277452The First Affiliated Hospital with Nanjing Medical University156
Recruiting
Phase 2
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)NCT07280156Protalix150
Recruiting
Phase 2
A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic ArthritisNCT07315061InventisBio Co., Ltd222