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

NCT05696613 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cerium Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2025-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696613 on ClinicalTrials.gov