A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy

NCT07851220 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 202501112025-523827-23-002025
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.

Conditions

Glomerulonephritis, Membranous

Keywords

Inebilizumab; AMG 335; Uplizna

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Complete Remission at Week 104

  At Week 104

Secondary Outcomes (17)

• Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104

  At Week 104

• Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78

  At Week 78

• Percentage of Participants Achieving Complete Remission at Week 78

  At Week 78

• Time to First Complete Remission by Week 104

  Up to Week 104

• Time to First Complete Remission or Partial Remission by Week 104

  Up to Week 104

Study Arms (2)

Inebilizumab

EXPERIMENTAL

Participants will receive inebilizumab via intravenous (IV) infusion

Drug: Inebilizumab

Tacrolimus

ACTIVE COMPARATOR

Participants will receive tacrolimus orally.

Drug: Tacrolimus

Interventions

Inebilizumab DRUG

Inebilizumab will be administered via IV infusion.

Also known as: AMG 335 / Uplizna

Inebilizumab

Tacrolimus DRUG

Tacrolimus will be administered orally

Tacrolimus

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years and \<80 years.
• Able and willing to provide written informed consent.
• Primary membranous nephropathy (PMN) confirmed by renal biopsy (performed during screening or within 5 years before screening), or biopsy exemption for participants with anti-PLA2R antibody ≥20 RU/mL at screening.
• Participants with diabetes Hemoglobin A1c (HbA1c) \<7.5% require a renal biopsy report within 2 years before screening (or biopsy during screening) demonstrating PMN without diabetic nephropathy.
• Urine protein-to-creatinine ratio (UPCR) ≥3.5 from a 24-hour urine collection at screening.
• Receiving a maximally tolerated Angiotensin-Converting Enzyme (ACE) inhibitor or (Angiotensin II receptor blocker) ARB for ≥3 months before randomization with adequately controlled blood pressure (\<140/90 mmHg).

You may not qualify if:

• Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications).
• Estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2 , ≥30% decline in eGFR during the previous 24 weeks, need for dialysis, kidney replacement therapy, kidney transplant, or planned transplant during the study.
• Recent thromboembolic event (within 3 months).
• Active HIV, hepatitis B infection, Hepatitis B surface antigen (HBsAg) positive, active hepatitis C infection, uncontrolled diabetes (HbA1c ≥7.5%), active or inadequately treated tuberculosis, recurrent herpes zoster or opportunistic infections, clinically significant active infection, recurrent serious infections, or immunodeficiency disorders.
• Clinically significant laboratory abnormalities, including severe anemia, neutropenia, thrombocytopenia, low Cluster of Differentiation (CD19+) B-cell count, hepatic dysfunction, or immunoglobulin G (IgG) \<400 mg/dL.
• History of solid organ or cell transplantation or progressive multifocal leukoencephalopathy.
• Recent treatment with prohibited therapies, including: B-cell-depleting biologics or other biologic immunomodulators, calcineurin inhibitors, alkylating agents within 3 months;( except history of resistance to calcineurin inhibitors); other immunosuppressive agents within 4 weeks; glucocorticoids within 1 month, or live or live-attenuated vaccines (within 4 weeks before randomization).

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

Academic Medical Research Institute

Los Angeles, California, 90022, United States

RECRUITING

Bioresearch Partner-Jackson West

Doral, Florida, 33122, United States

RECRUITING

Bioresearch Partner- Martin Luther King Jr.

Miami, Florida, 33127, United States

RECRUITING

Bioresearch Partner- Pembroke Pines

Pembroke Pines, Florida, 33029, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

inebilizumab; Tacrolimus

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 27, 2031
• Study Completion (Estimated): September 26, 2033
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (4)