A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

NCT06685757 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 299AR3012024-519095-66-00
• Study Type: interventional
• Target: 120
• Locations: 11 countries
• Sites: 55

Brief Summary

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is:

• How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about:
• How long it takes before the participants' disease gets worse
• How long the participants' urine protein levels stay low
• Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year
• How many people have no blood vessel inflammation at these times
• Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment
• Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year
• Changes in kidney function from the start of treatment
• How many people have biopsy results showing their kidney tissue looks normal again
• How long the transplanted kidney keeps working
• How many participants have medical problems during the study
• How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52
• How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time
• How felzartamab is processed by the body
• How many participants develop antibodies against felzartamab in the blood The study will be done as follows:
• Participants will be screened to check if they can join the study. This will take up to 42 days.
• There will be 2 parts in this study.
• Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo.
• Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab.
• All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight.
• Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.

Conditions

Antibody-mediated Rejection

Keywords

AMR; Felzartamab; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (19)

• 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 Donor-derived Cell-free DNA (dd-cfDNA)

  Baseline, Week 24

• Part A: Biopsy-based Transcript Composite Score for AMR/MVI

  At Week 24

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

  Baseline, Week 24

Study Arms (2)

Felzartamab

EXPERIMENTAL

Drug: Felzartamab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Felzartamab DRUG

Participants will receive felzartamab by intravenous infusion.

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

Felzartamab

Placebo DRUG

Participants will receive 0.9% saline solution by intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
• Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
• Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen 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.
• Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.
• Treatment: Prior AMR/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 AMR and to determine eligibility:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• Tocilizumab.
• Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] 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 (59)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Providence Healthcare

Orange, California, 92868, United States

RECRUITING

Loma Linda

San Bernardino, California, 92408, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, 94109, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

University of Nebraska

Omaha, Nebraska, 68198-5331, United States

RECRUITING

Cooperman Barnabas Medical Center

West Orange, New Jersey, 07039, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Penn Medicine - Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Instituto de Trasplante y Alta Complejidad (ITAC)

Cdad, Autónoma de Buenos Aires, C1425 C1425EGH, Argentina

RECRUITING

Clinica Privada Velez Sarsfield

Córdoba, X5000, Argentina

RECRUITING

Royal Melbourne Hospital

Parkville VIC, Australia, 3050, Australia

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, QLD 4102, Australia

RECRUITING

Medical University of Vienna

Spitalgasse, Vienna, 1090, Austria

RECRUITING

Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer

Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

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 das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Cerqueira César, São Paulo, 05403-010, Brazil

RECRUITING

Fundação Oswaldo Ramos - Hospital do Rim (HRIM)

Vila Clementino, São Paulo, 04038-002, Brazil

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

McGill University

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Institute for Clinical and Experimental Medicine (IKEM)

Czechia, Praha 4, 14021, Czechia

RECRUITING

CHU Lyon Hôpital Edouard Herriot

Bordeaux, 32000, France

RECRUITING

CHU Grenoble Alpes Hôpital Michallon

La Tronche, 38700, France

RECRUITING

Hospices Civils de Lyon - Hôpital Édouard Herriot

Lyon, 69003, France

RECRUITING

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

Toulouse, 31400, France

RECRUITING

Charite University

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 1307, Germany

RECRUITING

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

RECRUITING

Hospital Clinic de Barcelona

Calle Villarroel, Barcelona, 8036, Spain

RECRUITING

Hospital del Mar

Ciutat Vella, Barcelona, 8003, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Horta-Guinardó, Barcelona, 8035, Spain

RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

University Hospital Basel

Petersgraben, Basel, 4031, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• Bohmig GA, Akifova A, Budde K. World Transplant Congress 2025 Highlights: Immunosuppression. Transplantation. 2026 Feb 1;110(2):e356-e362. doi: 10.1097/TP.0000000000005569. Epub 2025 Dec 23.

  PMID: 41430762 DERIVED

MeSH Terms

Interventions

felzartamab

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Central Study Contacts

US Biogen Clinical Trial Center

CONTACT

1-866-633-4636; clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

CONTACT

clinicaltrials@biogen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (4); NZ (1); FR (4); ES (5); CZ (1); BR (4); AU (1); CH (2); US (27); AR (2); CA (4)