Recruiting
Phase 3

SNP-ACTH (1-39) Gel

Sponsor:

Cerium Pharmaceuticals, Inc.

Code:

NCT05696613

Conditions

Primary Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SNP-ACTH (1-39) Gel

Rituximab

Study Details

Brief 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

Primary Membranous Nephropathy

Study ID

NCT05696613

Start date

Mar 13, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test.
  • Patients classified to be at a High Risk for progressive loss of kidney function, as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular Diseases Guideline.
  • eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2
  • Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 3 months since their last dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolate mofetil
  • Patients who have had CR or PR in response to IS therapy, but then relapsed can participate in the study if it has been more than 6 months since their last dose of chlorambucil or cyclophosphamide
  • Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 12 months since their last dose of rituximab.
  • Life expectancy > 24 months.
  • Other inclusion criteria may apply.

Exclusion Criteria:

  • Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies.
  • Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.
  • Type 1 or 2 diabetes mellitus
  • Patients who must be initiated on drugs likely to affect renal function if not properly dosed.
  • Surgery within 1 month of study entry
  • History of sensitivity to proteins of porcine origin.
  • Other exclusion criteria may apply.

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 3a Cohort 1

3 mg SNP-ACTH Gel sc injection 3 times per week

experimental: Phase 3a Cohort 2

5 mg SNP-ACTH Gel sc injection 3 times per week

experimental: Phase 3b Cohort 1

Dose level to be confirmed once Phase 3a part is completed

active comparator: Phase 3b Cohort 2

Rituximab arm: Patients randomized to the rituximab arm will receive 1 g IV infusion on T0 (after baseline measures are collected) and day 15. A second course of rituximab 1g IV infusion will be administered 6 months after the first rituximab infusion and an additional 1 g IV infusion 14 days following the first 6-month infusion.

Interventions

SNP-ACTH (1-39) Gel

Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

Rituximab

Subjects will be randomly assigned in 1:1 treatment allocation ratio to receive the test and reference product.

Primary outcome measure

  • Change in urinary protein (Phase 3a) [ Time Frame: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12 ]
  • Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a) [ Time Frame: Change from baseline, months 1, 2, 3, 4, 6, and 12 ]
  • Complete response of PMN (Phase 3b) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Nancy Klett, MPH

703-395-0629Nancy.Klett@ceriumpharma.com

Locations

Academic Medical Research Institute

Recruiting

Los Angeles, California, United States, 90022

North America Research Institute

Recruiting

San Dimas, California, United States, 91773

Valiance Clinical Research

Recruiting

Tarzana, California, United States, 91356

RecioMed Clinical Research Network, Inc.

Recruiting

Boynton Beach, Florida, United States, 33472

South Florida Nephrology Research

Recruiting

Coral Springs, Florida, United States, 33071

Therafirst Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33308

Reliant Medical Research, LLC

Recruiting

Miami, Florida, United States, 33165

Vista Health Research, LLC

Recruiting

Miami, Florida, United States, 33176

Genesis Clinical Research

Recruiting

Tampa, Florida, United States, 33603

Fides Clinical Research

Recruiting

Atlanta, Georgia, United States, 30342

Costal Medical Research

Recruiting

Brunswick, Georgia, United States, 31520

Insight Hospital and Medical Center Chicago

Recruiting

Chicago, Illinois, United States, 60615

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Center for Advanced Kidney Research, PLC

Recruiting

Saint Clair Shores, Michigan, United States, 48080

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

P&I Clinical Research LLC

Recruiting

Lufkin, Texas, United States, 75904

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Nephrology Associates of Northern Virginia

Recruiting

Fairfax, Virginia, United States, 22033

Regional Kidney Wellness Centre

Recruiting

Brampton, Ontario, Canada, L6T 0H9

More Information

Sponsor

Cerium Pharmaceuticals, Inc.

Last update posted

Jun 25, 2026

Last verified

Mar, 2026

Keywords

  • Kidney disease
  • Rituximab
  • Nephritis
  • Melanocortin
  • Hormones
  • Glucocorticoids
  • Glomerular Disease
  • ACTH
  • PMN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cerium Pharmaceuticals, Inc. on 2026-06-25.