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IPG11406 in Patients With Lupus Nephritis
NCT06717815Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2025
- Primary completion
- Jun 2026
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- IPG11406
- Conditions
- lupus nephritis (LN)
01
Overview
Phase 2, open-label trial of IPG11406 in lupus nephritis (LN) (3 cohorts), sponsored by Nanjing Immunophage Biotech Co., Ltd. Primary endpoints: Adverse Events up to 58 days, Vital Signs up to 58 days and 6 more. Started Feb 2025; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Cohort 1 (20 mg, Bid)
IPG11406 20 mg twice a day
Cohort 2 (40 mg, Bid)
IPG11406 40 mg twice a day
Cohort 3 (80 mg, Bid)
IPG11406 80 mg twice a day
03
Who it enrols
Adults with systemic lupus erythematosus and active lupus nephritis (SLEDAI-2K >= 6, UPCR > 0.5 g/g, eGFR >= 60), excluding those with severe neuropsychiatric SLE, active infections, or significant cardiac impairment.
04
Endpoints
Primary
Adverse Events
Vital Signs
Laboratory Examination
Electrocardiogram
Biomarkers
Secondary
Maximum Plasma Concentration
Area Under the Curve
Clearance
Half-life
Systemic Lupus Erythematosus Disease Activity Index 2000
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