Clinical trial NCT05065970: Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Official title: A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immunoglobulin A (IgA) Nephropathy
Keywords: Kidney Disease
Urologic Disease
Glomerular Disease
Berger Disease
Glomerulonephritis, IGA
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy: Relative change in Proteinuria value
timeFrame: 9 months compared to baseline
Secondary outcomes:
measure: Safety: determined by the frequency, incidence and severity of TEAEs
timeFrame: Ongoing through study completion, up to 2 years
measure: Efficacy: Relative change in proteinuria value
timeFrame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
measure: Efficacy: complete response in patients with IgAN
timeFrame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
measure: Pharmacokinetic: serum concentrations of Felzartamab over time
timeFrame: Ongoing through treatment completion, up to 2 years
Other outcomes:
Locations:
city: Oxnard
country: United States
facility: FOMAT Medical Research - FOMAT - HyperCore - PPDS
state: California
city: Vacaville
country: United States
facility: Amicis Research Center, Vacaville
state: California
city: Rochester
country: United States
facility: Mayo Clinic Hospital - Methodist Campus
state: Minnesota
city: El Paso
country: United States
facility: MedResearch INC
state: Texas
city: Milton
country: Australia
facility: Core Research Group
state: Queensland
city: Saint Albans
country: Australia
facility: Sunshine Hospital - Australia
state: Victoria
city: Bonheiden
country: Belgium
facility: Imelda VZW
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven Hospital
state: Vlaams Brabant
city: Ieper
country: Belgium
facility: Regionaal Ziekenhuis Jan Yperman VZW
city: Liège
country: Belgium
facility: CHU Sart Tilman Hospital
city: Sofia
country: Bulgaria
facility: Diagnostic- Consultative Center Convex EOOD
state: Sofia-Grad
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD, Montana
city: Plovdiv
country: Bulgaria
facility: Medical Center Hipokrat- N EOOD
city: Stara Zagora
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment
city: Nový Jicín
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s
state: Moravskoslezský Kraj
city: Olomouc
country: Czechia
facility: Eticka komise Fakultni nemocnice Olomouc
state: Olomoucký Kraj
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady Hospital
state: Praha, Hlavní Mesto
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
state: Praha, Hlavní Mesto
city: Tbilisi
country: Georgia
facility: JSC Evex Hospitals
city: Tbilisi
country: Georgia
facility: L. Managadze National Center of Urology LTD
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Sapporo-Shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidô
city: Kitakyushu-Shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Hukuoka
city: Kurume-Shi
country: Japan
facility: Kurume University Hospital
state: Hukuoka
city: Fukushima-Shi
country: Japan
facility: Fukushima Medical University Hospital
state: Hukusima
city: Sendai
country: Japan
facility: JCHO Sendai Hospital
state: Miyagi
city: Chiba-Shi
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
state: Tiba
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Ashikaga-Shi
country: Japan
facility: Japanese Red Cross Ashikaga Hospital
state: Totigi
city: Suita-Shi
country: Japan
facility: Osaka University Hospital
state: Ôsaka
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul Teugbyeolsi
city: Uijeongbu-Si
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Pantai
country: Malaysia
facility: University Malaya Medical Centre
city: Santo Tomas
country: Philippines
facility: St Frances Cabrini Medical Center and Cancer Institute
state: Batangas
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Krusevac
country: Serbia
facility: General Hospital Krusevac
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Badalona
country: Spain
facility: Fundacio Puigvert
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Ruber Juan Bravo (Grupo Quironsalud)
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Ternopil'
country: Ukraine
facility: Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
state: Ternopil's'ka Oblast
city: Kyiv
country: Ukraine
facility: Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
city: Kyiv
country: Ukraine
facility: State Institution Institute of Nephrology of NAMS of Ukraine
city: Zaporizhzhia
country: Ukraine
facility: Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: HI-Bio, A Biogen Company
name: Medical Director
role: STUDY_DIRECTOR
References: