Recruiting
Phase 3

Inebilizumab

Sponsor:

Amgen

Code:

NCT07851220

Conditions

Glomerulonephritis, Membranous

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Inebilizumab

Tacrolimus

Study Details

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

Study ID

NCT07851220

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Sep 26, 2033

Anticipated

Primary completion date

Sep 27, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

159 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inebilizumab

Participants will receive inebilizumab via intravenous (IV) infusion

active comparator: Tacrolimus

Participants will receive tacrolimus orally.

Interventions

Inebilizumab

Inebilizumab will be administered via IV infusion.

Tacrolimus

Tacrolimus will be administered orally

Primary outcome measure

  • Percentage of Participants Achieving Complete Remission at Week 104 [ Time Frame: At Week 104 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Academic Medical Research Institute

Recruiting

Los Angeles, California, United States, 90022

Bioresearch Partner-Jackson West

Recruiting

Doral, Florida, United States, 33122

Bioresearch Partner- Martin Luther King Jr.

Recruiting

Miami, Florida, United States, 33127

Bioresearch Partner- Pembroke Pines

Recruiting

Pembroke Pines, Florida, United States, 33029

More Information

Sponsor

Amgen

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Inebilizumab
  • AMG 335
  • Uplizna

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Amgen on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.