NCT05696613

A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy

A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel Compared to Rituximab and FDA Approved Biosimilars in Adults With Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Cerium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24.

Detailed description

This head-to-head, open-label, 2-phase superiority trial compares SNP-ACTH (1-39) Gel to rituximab in the treatment of PMN that commences with an adaptive trial design for dose finding. The trial will be divided into 2 parts: Phase 3a and Phase 3b. Dose finding Phase 3a part of the study will enroll a total of 16 patients randomized to 2 different dose levels of SNP-ACTH (1-39) Gel treatment for 12 months. Dose levels will be: * 8 patients at 3mg SNP-ACTH Gel subcutaneous (sc) injection 3 times per week; * 8 patients at 5mg SNP-ACTH Gel sc injection 3 times per week Data from the Phase 3a part of the study will be assessed at regular intervals (at months 2, 3, 4, 5, 6, 9, 12) and will inform the dose selection for the Phase 3b. The optimal dose will be determined based on a risk/benefit assessment from data obtained from the Phase 3a part of the study, with the earliest assessment being conducted after all patients have completed at least 2 months of therapy. The Phase 3b part of the study will enroll 132 patients randomized 1:1 to either 12 months of 1g Rituximab therapy (2 treatment cycles at month 1 and month 6) or 12 months of SNP-ACTH (1-39) Gel treatment at the dose level determined in the Phase 3a.

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	SNP-ACTH (1-39) Gel	Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.
DRUG	Rituximab	Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

Timeline

• Start date: 2023-03-13
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-01-25
• Last updated: 2024-04-25

Locations

31 sites across 3 countries: United States, Canada, India

Regulatory

• FDA-regulated drug study