NCT06717815

Phase IIa Study for IPG11406 in Patients With Lupus Nephritis

A Multi-center, Multi-dose Phase Ib/IIa Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Impact on Biomarkers of IPG11406 in Patients With Lupus Nephritis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Nanjing Immunophage Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, multi-dose phase Ib/IIa clinical study evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis

Detailed description

This is a multi-center, multi-dose phase Ib/IIa study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis. Part A Three dose groups will be administered with drugs, namely 20 mg bid (cohort 1), 40 mg bid (cohort 2), and 80 mg bid (cohort 3). In cohorts 1 to 3, there will be 9-12 subjects in each cohort. All subjects will undergo screening for 28 days before administration, and those who pass the screening will undergo 28 days of drug administration and observation. This part plans to recruit about 36 patients with Lupus Nephritis. After each cohort completes 28 days of dosing and evaluation, the Safety Monitoring Committee (SMC) will assess the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available pharmacokinetic (PK) data under blinded conditions. Based on the results of the safety and tolerability assessment, the SMC will decide whether to proceed with dosing in the next dose cohort. Part A will determine the recommended phase II dose (RP2D) and maximum tolerated dose (MTD) of IPG11406. Part B The design of Part B will be finalized based on the results of Part A.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	IPG11406	Investigational Medical Products: IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 10 mg and 40 mg Storage：15 \~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 tablets are orally administered twice a Day with an interval of 12±1 hours. Tablets should not be chewed or crushed.

Timeline

• Start date: 2025-02-25
• Primary completion: 2026-04-22
• Completion: 2026-04-22
• First posted: 2024-12-05
• Last updated: 2026-01-13

Locations

17 sites across 1 country: China

Regulatory

• FDA-regulated drug study