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Felzartamab

DRUG13 trials

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri, Biogen Idec Research Limited, Farsad Eskandary, HI-Bio, A Biogen Company, Biogen

Conditions

Antibody-mediated RejectionGraves' DiseaseIgA nephropathyImmunoglobulin A (IgA) NephropathyImmunoglobulin A Nephropathy (IgAN)Kidney Transplant Recipients with Late Antibody-Mediated RejectionLupus NephritisMembranous nephropathy

Phase 1

Phase 2

Felzartamab in Late Antibody-Mediated Rejection
CompletedNCT05021484
Farsad EskandaryAntibody-mediated Rejection
Start: 2021-10-06End: 2024-03-07Updated: 2024-04-18
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
CompletedNCT05065970
HI-Bio, A Biogen CompanyImmunoglobulin A (IgA) Nephropathy
Start: 2021-08-31End: 2024-05-06Updated: 2026-04-28
Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (felzartamab) in Patients with Membranous Nephropathy who Failed Anti-CD20 Target Therapy (MONET study)
CompletedCTIS2024-513744-28-00
Istituto Di Ricerche Farmacologiche Mario NegriMembranous nephropathy
Start: 2021-10-22End: 2025-02-21Target: 10Updated: 2024-09-25
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
RecruitingNCT07219043
BiogenMicrovascular Inflammation
Start: 2026-01-05End: 2028-02-10Target: 81Updated: 2026-09-04
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI)- (299AR201-TRANSPIRE)
Not yet recruitingCTIS2025-521742-15-00
Biogen Idec Research LimitedTreatment of Late Isolated Microvascular Inflammation in Recipients of Kidney Transplants
Target: 13Updated: 2026-02-10
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
RecruitingNCT07722546
BiogenGraves' Disease
Start: 2026-07-30End: 2028-03-31Target: 60Updated: 2026-09-04

Phase 3

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
Active, not recruitingNCT06685757
BiogenAntibody-mediated Rejection
Start: 2024-12-03End: 2027-06-01Updated: 2026-06-05
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
RecruitingNCT06935357
BiogenImmunoglobulin A Nephropathy (IgAN)
Start: 2025-05-08End: 2029-06-05Target: 454Updated: 2026-09-02
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
RecruitingNCT06962800
BiogenPrimary Membranous Nephropathy
Start: 2025-05-22End: 2031-01-17Target: 180Updated: 2026-08-26
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients with Late Antibody-Mediated Rejection (AMR) (TRANSCEND / 299AR301)
RecruitingCTIS2024-519095-66-00
Biogen Idec Research LimitedKidney Transplant Recipients with Late Antibody-Mediated Rejection
Start: 2025-07-23Target: 49Updated: 2025-12-04
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
RecruitingCTIS2024-519345-30-00
Biogen Idec Research LimitedIgA nephropathy
Start: 2025-11-12Target: 201Updated: 2025-10-30
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Enrolling by invitationNCT07444489
BiogenAntibody-mediated Rejection, Microvascular Inflammation
Start: 2026-04-16End: 2031-05-28Target: 201Updated: 2026-09-09

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