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Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy (IGNAZ)

Primary Purpose

Immunoglobulin A (IgA) Nephropathy

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Felzartamab
Placebo
Sponsored by
HI-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunoglobulin A (IgA) Nephropathy focused on measuring Kidney Disease, Urologic Disease, Glomerular Disease, Berger Disease, Glomerulonephritis, IGA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FOMAT Medical Research - FOMAT - HyperCore - PPDS
  • Amicis Research Center, Vacaville
  • Mayo Clinic Hospital - Methodist Campus
  • MedResearch INC
  • Core Research Group
  • Sunshine Hospital - Australia
  • Imelda VZW
  • UZ Leuven Hospital
  • Regionaal Ziekenhuis Jan Yperman VZW
  • CHU Sart Tilman Hospital
  • Diagnostic- Consultative Center Convex EOOD
  • Medical Center Hera EOOD, Montana
  • Medical Center Hipokrat- N EOOD
  • University Multiprofile Hospital for Active Treatment
  • Nemocnice AGEL Novy Jicin a.s
  • Eticka komise Fakultni nemocnice Olomouc
  • Fakultni nemocnice Kralovske Vinohrady Hospital
  • Vseobecna Fakultni Nemocnice V Praze
  • JSC Evex Hospitals
  • L. Managadze National Center of Urology LTD
  • Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Essen
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Hokkaido University Hospital
  • Hospital of the University of Occupational and Environmental Health, Japan
  • Kurume University Hospital
  • Fukushima Medical University Hospital
  • JCHO Sendai Hospital
  • National Hospital Organization Chibahigashi National Hospital
  • Juntendo University Hospital
  • Japanese Red Cross Ashikaga Hospital
  • Osaka University Hospital
  • Seoul National University Bundang Hospital
  • Ajou University Hospital
  • Konkuk University Medical Center
  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • University Malaya Medical Centre
  • St Frances Cabrini Medical Center and Cancer Institute
  • Clinical Centre of Vojvodina
  • Clinical Hospital Center Bezanijska Kosa
  • Clinical Hospital Centar Zvezdara
  • General Hospital Krusevac
  • University Clinical Center Nis
  • Fundacio Puigvert
  • Hospital Universitario Germans Trias i Pujol
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron - PPDS
  • Hospital Clinic de Barcelona
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitari Arnau de Vilanova
  • Hospital Ruber Juan Bravo (Grupo Quironsalud)
  • Taipei Medical University Shuang Ho Hospital
  • Taichung Veterans General Hospital
  • Far Eastern Memorial Hospital
  • Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
  • Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
  • State Institution Institute of Nephrology of NAMS of Ukraine
  • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
  • Kings College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Felzartamab Arm #1

Felzartamab Arm #2

Felzartamab Arm #3

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: Relative change in Proteinuria value

Secondary Outcome Measures

Safety: determined by the frequency, incidence and severity of TEAEs
Efficacy: Relative change in proteinuria value
Efficacy: complete response in patients with IgAN
Pharmacokinetic: serum concentrations of Felzartamab over time

Full Information

First Posted
September 14, 2021
Last Updated
September 25, 2023
Sponsor
HI-Bio
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1. Study Identification

Unique Protocol Identification Number
NCT05065970
Brief Title
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Acronym
IGNAZ
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HI-Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunoglobulin A (IgA) Nephropathy
Keywords
Kidney Disease, Urologic Disease, Glomerular Disease, Berger Disease, Glomerulonephritis, IGA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Felzartamab Arm #1
Arm Type
Experimental
Arm Title
Felzartamab Arm #2
Arm Type
Experimental
Arm Title
Felzartamab Arm #3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Felzartamab
Other Intervention Name(s)
MOR202
Intervention Description
anti-CD38+ monoclonal antibody
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Efficacy: Relative change in Proteinuria value
Time Frame
9 months compared to baseline
Secondary Outcome Measure Information:
Title
Safety: determined by the frequency, incidence and severity of TEAEs
Time Frame
Ongoing through study completion, up to 2 years
Title
Efficacy: Relative change in proteinuria value
Time Frame
Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Title
Efficacy: complete response in patients with IgAN
Time Frame
Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Title
Pharmacokinetic: serum concentrations of Felzartamab over time
Time Frame
Ongoing through treatment completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HI-Bio Clinical Program Lead
Organizational Affiliation
HI-Bio
Official's Role
Study Director
Facility Information:
Facility Name
FOMAT Medical Research - FOMAT - HyperCore - PPDS
City
Oxnard
State/Province
California
ZIP/Postal Code
93030-5822
Country
United States
Facility Name
Amicis Research Center, Vacaville
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Mayo Clinic Hospital - Methodist Campus
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
MedResearch INC
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Core Research Group
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Sunshine Hospital - Australia
City
Saint Albans
State/Province
Victoria
Country
Australia
Facility Name
Imelda VZW
City
Bonheiden
State/Province
Antwerpen
Country
Belgium
Facility Name
UZ Leuven Hospital
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Regionaal Ziekenhuis Jan Yperman VZW
City
Ieper
Country
Belgium
Facility Name
CHU Sart Tilman Hospital
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Diagnostic- Consultative Center Convex EOOD
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Medical Center Hera EOOD, Montana
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Medical Center Hipokrat- N EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment
City
Stara Zagora
Country
Bulgaria
Facility Name
Nemocnice AGEL Novy Jicin a.s
City
Nový Jicín
State/Province
Moravskoslezský Kraj
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Eticka komise Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady Hospital
City
Prague
State/Province
Praha, Hlavní Mesto
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Praha
State/Province
Praha, Hlavní Mesto
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
JSC Evex Hospitals
City
Tbilisi
ZIP/Postal Code
121
Country
Georgia
Facility Name
L. Managadze National Center of Urology LTD
City
Tbilisi
ZIP/Postal Code
144
Country
Georgia
Facility Name
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
City
Tbilisi
ZIP/Postal Code
144
Country
Georgia
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Facility Name
Hokkaido University Hospital
City
Sapporo-Shi
State/Province
Hokkaidô
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan
City
Kitakyushu-Shi
State/Province
Hukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-Shi
State/Province
Hukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-Shi
State/Province
Hukusima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
JCHO Sendai Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-3205
Country
Japan
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba-Shi
State/Province
Tiba
ZIP/Postal Code
260-0801
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Japanese Red Cross Ashikaga Hospital
City
Ashikaga-Shi
State/Province
Totigi
ZIP/Postal Code
326-0843
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-Shi
State/Province
Ôsaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
5030
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Uijeongbu-Si
Country
Korea, Republic of
Facility Name
University Malaya Medical Centre
City
Pantai
Country
Malaysia
Facility Name
St Frances Cabrini Medical Center and Cancer Institute
City
Santo Tomas
State/Province
Batangas
ZIP/Postal Code
4234
Country
Philippines
Facility Name
Clinical Centre of Vojvodina
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Hospital Centar Zvezdara
City
Belgrade
Country
Serbia
Facility Name
General Hospital Krusevac
City
Krusevac
ZIP/Postal Code
37000
Country
Serbia
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Fundacio Puigvert
City
Badalona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitari de Girona Dr Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Ruber Juan Bravo (Grupo Quironsalud)
City
Madrid
Country
Spain
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
City
Ternopil'
State/Province
Ternopil's'ka Oblast
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
City
Kyiv
Country
Ukraine
Facility Name
State Institution Institute of Nephrology of NAMS of Ukraine
City
Kyiv
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Kings College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.

Learn more about this trial

Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy

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