Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
- Conditions
- Immunoglobulin A (IgA) Nephropathy
- Interventions
- Other: Placebo
- Registration Number
- NCT05065970
- Lead Sponsor
- HI-Bio, A Biogen Company
- Brief Summary
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
- Detailed Description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country
- 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
Key
- Hemoglobin < 90 g/L
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Felzartamab Arm #2 Felzartamab - Felzartamab Arm #1 Felzartamab - Felzartamab Arm #3 Felzartamab -
- Primary Outcome Measures
Name Time Method Efficacy: Relative change in Proteinuria value 9 months compared to baseline
- Secondary Outcome Measures
Name Time Method Pharmacokinetic: serum concentrations of Felzartamab over time Ongoing through treatment completion, up to 2 years Safety: determined by the frequency, incidence and severity of TEAEs Ongoing through study completion, up to 2 years Efficacy: Relative change in proteinuria value Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years Efficacy: complete response in patients with IgAN Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Trial Locations
- Locations (60)
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Fakultni nemocnice Kralovske Vinohrady Hospital
🇨🇿Prague, Praha, Hlavní Mesto, Czechia
JSC Evex Hospitals
🇬🇪Tbilisi, Georgia
JCHO Sendai Hospital
🇯🇵Sendai, Miyagi, Japan
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
Hokkaido University Hospital
🇯🇵Sapporo-Shi, Hokkaidô, Japan
MedResearch INC
🇺🇸El Paso, Texas, United States
Amicis Research Center, Vacaville
🇺🇸Vacaville, California, United States
FOMAT Medical Research - FOMAT - HyperCore - PPDS
🇺🇸Oxnard, California, United States
Core Research Group
🇦🇺Milton, Queensland, Australia
Mayo Clinic Hospital - Methodist Campus
🇺🇸Rochester, Minnesota, United States
UZ Leuven Hospital
🇧🇪Leuven, Vlaams Brabant, Belgium
Imelda VZW
🇧🇪Bonheiden, Antwerpen, Belgium
Sunshine Hospital - Australia
🇦🇺Saint Albans, Victoria, Australia
Regionaal Ziekenhuis Jan Yperman VZW
🇧🇪Ieper, Belgium
CHU Sart Tilman Hospital
🇧🇪Liège, Belgium
Medical Center Hera EOOD, Montana
🇧🇬Montana, Bulgaria
Diagnostic- Consultative Center Convex EOOD
🇧🇬Sofia, Sofia-Grad, Bulgaria
Medical Center Hipokrat- N EOOD
🇧🇬Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment
🇧🇬Stara Zagora, Bulgaria
Eticka komise Fakultni nemocnice Olomouc
🇨🇿Olomouc, Olomoucký Kraj, Czechia
Nemocnice AGEL Novy Jicin a.s
🇨🇿Nový Jicín, Moravskoslezský Kraj, Czechia
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
🇬🇪Tbilisi, Georgia
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
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-Shi, Hukusima, Japan
National Hospital Organization Chibahigashi National Hospital
🇯🇵Chiba-Shi, Tiba, Japan
Japanese Red Cross Ashikaga Hospital
🇯🇵Ashikaga-Shi, Totigi, Japan
Juntendo University Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Osaka University Hospital
🇯🇵Suita-Shi, Ôsaka, Japan
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
University Malaya Medical Centre
🇲🇾Pantai, Malaysia
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu-Si, Korea, Republic of
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
University Clinical Center Nis
🇷🇸Nis, Serbia
General Hospital Krusevac
🇷🇸Krusevac, Serbia
Clinical Hospital Centar Zvezdara
🇷🇸Belgrade, Serbia
Fundacio Puigvert
🇪🇸Badalona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Far Eastern Memorial Hospital
🇨🇳Taipei, Taiwan
Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
🇺🇦Kyiv, Ukraine
State Institution Institute of Nephrology of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
Kings College Hospital
🇬🇧London, United Kingdom
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
🇺🇦Zaporizhzhia, Ukraine
Konkuk University Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Ruber Juan Bravo (Grupo Quironsalud)
🇪🇸Madrid, Spain
L. Managadze National Center of Urology LTD
🇬🇪Tbilisi, Georgia
Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
🇺🇦Ternopil', Ternopil's'ka Oblast, Ukraine