Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
NCT ID: NCT05065970
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2021-08-31
2024-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo comparator
Felzartamab Arm #1
Felzartamab
anti-CD38+ monoclonal antibody
Felzartamab Arm #2
Felzartamab
anti-CD38+ monoclonal antibody
Felzartamab Arm #3
Felzartamab
anti-CD38+ monoclonal antibody
Interventions
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Felzartamab
anti-CD38+ monoclonal antibody
Placebo
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
* Proteinuria at screening visit ≥ 1.0 g/d.
* Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control.
* A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP
Exclusion Criteria
* Thrombocytopenia: Platelets \< 100.0 x 10\^9/L.
* Neutropenia: Neutrophils \< 1.5 x 10\^9/L.
* Leukopenia: Leukocytes \< 3.0 x 10\^9/L
* Diabetes mellitus type 1
* Aspartate aminotransferase or alanine aminotransferase \>1.5 x ULN, alkaline phosphatase \>3.0 x ULN
18 Years
80 Years
ALL
No
Sponsors
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HI-Bio, A Biogen Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
HI-Bio, A Biogen Company
Locations
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FOMAT Medical Research - FOMAT - HyperCore - PPDS
Oxnard, California, United States
Amicis Research Center, Vacaville
Vacaville, California, United States
Mayo Clinic Hospital - Methodist Campus
Rochester, Minnesota, United States
MedResearch INC
El Paso, Texas, United States
Core Research Group
Milton, Queensland, Australia
Sunshine Hospital - Australia
Saint Albans, Victoria, Australia
Imelda VZW
Bonheiden, Antwerpen, Belgium
UZ Leuven Hospital
Leuven, Vlaams Brabant, Belgium
Regionaal Ziekenhuis Jan Yperman VZW
Ieper, , Belgium
CHU Sart Tilman Hospital
Liège, , Belgium
Diagnostic- Consultative Center Convex EOOD
Sofia, Sofia-Grad, Bulgaria
Medical Center Hera EOOD, Montana
Montana, , Bulgaria
Medical Center Hipokrat- N EOOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment
Stara Zagora, , Bulgaria
Nemocnice AGEL Novy Jicin a.s
Nový Jicín, Moravskoslezský kraj, Czechia
Eticka komise Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady Hospital
Prague, Praha, Hlavní Mesto, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Praha, Hlavní Mesto, Czechia
JSC Evex Hospitals
Tbilisi, , Georgia
L. Managadze National Center of Urology LTD
Tbilisi, , Georgia
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
Tbilisi, , Georgia
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-Shi, Hukuoka, Japan
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Hukusima, Japan
JCHO Sendai Hospital
Sendai, Miyagi, Japan
Japanese Red Cross Ashikaga Hospital
Ashikaga-Shi, Tochigi, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Osaka University Hospital
Suita-Shi, Ôsaka, Japan
University Malaya Medical Centre
Pantai, , Malaysia
St Frances Cabrini Medical Center and Cancer Institute
Santo Tomas, Batangas, Philippines
Clinical Centre of Vojvodina
Novi Sad, Vojvodina, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Clinical Hospital Centar Zvezdara
Belgrade, , Serbia
General Hospital Krusevac
Kruševac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, South Korea
Ajou University Hospital
Suwon, Gyeonggido, South Korea
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Fundacio Puigvert
Badalona, , Spain
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Ruber Juan Bravo (Grupo Quironsalud)
Madrid, , Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Far Eastern Memorial Hospital
Taipei, , Taiwan
Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
Ternopil, Ternopil Oblast, Ukraine
Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
Kyiv, , Ukraine
State Institution Institute of Nephrology of NAMS of Ukraine
Kyiv, , Ukraine
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
Zaporizhzhia, , Ukraine
Kings College Hospital
London, , United Kingdom
Countries
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References
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Floege J, Lafayette R, Barratt J, Schwartz B, Manser PT, Patel UD, Shah M, Kivman L, Faulhaber N, Kraft T, Thakur A, Hartle S, Barbour SJ. Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy. Kidney Int. 2025 Oct;108(4):695-706. doi: 10.1016/j.kint.2025.05.028. Epub 2025 Jun 26.
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.
Other Identifiers
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MOR202C206
Identifier Type: -
Identifier Source: org_study_id
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