A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

NCT07219043 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 299AR2012025-521742-15
• Study Type: interventional
• Target: 81
• Locations: 7 countries
• Sites: 23

Brief Summary

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time. In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI. The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:

• How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab? Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study. Adverse events are health problems that may or may not be caused by the study drug. The study will be done in 2 parts as follows:
• Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
• In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
• Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
• All treatments will be given by intravenous (IV) infusion at the study site.
• Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
• Participants will stay in the study for about 1 year.

Conditions

Microvascular Inflammation

Keywords

Kidney Transplant; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)

  Week 24

Secondary Outcomes (16)

• Part A: Microvascular Inflammation (MVI) Score

  Week 24

• Part A: Percentage of Participants Who Achieve an MVI Score of 0

  Week 24

• Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

  Baseline, Week 24

• Part A: Percentage of Participants in Cohort 2 Who Achieve BPHR

  Week 24

• Part B: Percentage of Participants Who Achieve BPHR

  Weeks 24 and 52

Study Arms (2)

Felzartamab

EXPERIMENTAL

Participants will receive multiple IV doses of felzartamab.

Drug: Felzartamab

Placebo and Felzartamab

PLACEBO COMPARATOR

Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab.

Drug: Felzartamab; Drug: Placebo

Interventions

Felzartamab DRUG

Administered IV

Also known as: MOR202, MOR03087, TJ202, HIB202, BIIB148

Felzartamab; Placebo and Felzartamab

Placebo DRUG

Administered IV

Placebo and Felzartamab

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria.
• Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
• Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries
• Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery
• Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
• DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization.

You may not qualify if:

• Transplant: Blood type (ABO)-incompatible transplant.
• History of multiple organ transplants including en bloc and dual kidney transplants.
• Presence of HLA donor-specific antibodies.
• Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator.
• Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing MVI≥2 and DSA negative status and to determine eligibility:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or plasma exchange (PLEX).
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab.
• Any B cell-depleting therapy (including anti-CD20 agents \[e.g., rituximab\]) within 3 months prior to randomization.
• Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.

Sponsors & Collaborators

• Biogen: lead

Study Sites (23)

Keck Hispital of University of Southern California (USC)

Los Angeles, California, 90033, United States

RECRUITING

Providence St. Joseph Hospital Orange

Orange, California, 92868, United States

RECRUITING

Sutter Health - California Pacific Medical Center

San Francisco, California, 94115, United States

RECRUITING

University of California San Fransisco (UCSF) Medical Center

San Francisco, California, 94158, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Cooperman Barnabas Medical Center

West Orange, New Jersey, 07039, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Medizinische Universität Wien

Vienna, 1090, Austria

RECRUITING

Hospital de Base da Faculdade de Medicina de São José do Rio Preto

Vila São José, São José Do Rio Preto, 15090-000, Brazil

RECRUITING

Hospital do Rim - Fundação Oswaldo Ramos

São Paulo, 04038-002, Brazil

RECRUITING

Institut klinicke a experimentalni mediciny (IKEM)

Prague, 104 21, Czechia

RECRUITING

Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil

Toulouse, 31400, France

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Hospital Del Mar

Barcelona, 8003, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 8035, Spain

RECRUITING

MeSH Terms

Interventions

felzartamab

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Central Study Contacts

US Biogen Clinical Trial Center

CONTACT

866-633-4636; clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

CONTACT

clinicaltrials@biogen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a 2-part trial: Part A will be randomized and placebo-controlled, and Part B will be open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (14); AU (1); ES (2); FR (1); BR (2); DE (2); CZ (1)