A Phase 2 interventional study of Felzartamab and Placebo in Microvascular Inflammation, sponsored by Biogen. Recruiting at 53 sites in 11 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Biogen · Phase 2, Interventional, and Treatment
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:
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:
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients in Cohort 1 (Part A). The secondary objectives of the study are to evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints (Part A), summarize efficacy of felzartamab up to Week 52 in kidney transplant recipients in Cohorts 1 and 2 (Part B); evaluate safety of felzartamab in kidney transplant recipients in Cohorts 1 and 2 (Parts A and B) and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab (Parts A and B).
Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive multiple IV doses of felzartamab.
Drug: Felzartamab
Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab.
Drug: Felzartamab · Drug: Placebo
Administered IV
Also known as: MOR202, MOR03087, TJ202, HIB202, BIIB148
Administered IV
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Time frame: Week 24
Part A: Microvascular Inflammation (MVI) Score
Time frame: Week 24
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Time frame: Week 24
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 24
Part A: Percentage of Participants in Cohort 2 Who Achieve BPHR
Time frame: Week 24
Part B: Percentage of Participants Who Achieve BPHR
Time frame: Weeks 24 and 52
Part B: MVI Score
Time frame: Weeks 24 and 52
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Time frame: Weeks 24 and 52
Part B: Change from Baseline in eGFR
Time frame: Baseline, Weeks 24 and 52
Part B: Time to All-cause Allograft Loss
Time frame: Up to Week 52
Parts A and B: Number of Participants with Adverse Events (AEs)
Time frame: From first dose of study drug up to end of study follow-up (up to week 57)
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Time frame: Weeks 24 and 52
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Felzartamab Serum Concentration
Time frame: Up to Week 52
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab
Time frame: Baseline, up to Week 52
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Feb 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Felzartamab