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

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

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

Study Overview

• Status: Completed
• Conditions: Immunoglobulin A (IgA) Nephropathy
• Intervention / Treatment: Other: Placebo; Drug: Felzartamab

Detailed Description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Milton, Queensland, Australia, 4064
      • Core Research Group
  • Victoria
    • Saint Albans, Victoria, Australia
      • Sunshine Hospital - Australia
• Belgium
  • Ieper, Belgium
    • Regionaal Ziekenhuis Jan Yperman VZW
  • Liège, Belgium, 4000
    • CHU Sart Tilman Hospital
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium
      • Imelda VZW
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven Hospital
• Bulgaria
  • Montana, Bulgaria, 3400
    • Medical Center Hera EOOD, Montana
  • Plovdiv, Bulgaria, 4000
    • Medical Center Hipokrat- N EOOD
  • Stara Zagora, Bulgaria
    • University Multiprofile Hospital for Active Treatment
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1680
      • Diagnostic- Consultative Center Convex EOOD
• Czechia
  • Moravian-Silesian Region
    • Nový Jicín, Moravian-Silesian Region, Czechia, 741 01
      • Nemocnice AGEL Novy Jicin a.s
  • Olomouc Region
    • Olomouc, Olomouc Region, Czechia, 775 20
      • Eticka komise Fakultni nemocnice Olomouc
  • Praha, Hlavní Mesto
    • Prague, Praha, Hlavní Mesto, Czechia, 10034
      • Fakultni nemocnice Kralovske Vinohrady Hospital
    • Prague, Praha, Hlavní Mesto, Czechia, 128 08
      • Vseobecna fakultni nemocnice v Praze
• Georgia
  • Tbilisi, Georgia, 121
    • JSC Evex Hospitals
  • Tbilisi, Georgia, 144
    • L. Managadze National Center of Urology LTD
  • Tbilisi, Georgia, 144
    • Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
• Germany
  • Mainz, Germany
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45122
      • Universitatsklinikum Essen
• Japan
  • Chiba
    • Chiba, Chiba, Japan, 260-0801
      • National Hospital Organization Chibahigashi National Hospital
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8648
      • Hokkaido University Hospital
  • Hukuoka
    • Kitakyushu-Shi, Hukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health, Japan
    • Kurume-Shi, Hukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hukusima
    • Fukushima, Hukusima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 981-3205
      • JCHO Sendai Hospital
  • Tochigi
    • Ashikaga-Shi, Tochigi, Japan, 326-0843
      • Japanese Red Cross Ashikaga Hospital
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
  • Ôsaka
    • Suita-Shi, Ôsaka, Japan, 565-0871
      • Osaka University Hospital
• Malaysia
  • Pantai, Malaysia
    • University Malaya Medical Centre
• Philippines
  • Batangas
    • Santo Tomas, Batangas, Philippines, 4234
      • St Frances Cabrini Medical Center and Cancer Institute
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Bezanijska Kosa
  • Belgrade, Serbia
    • Clinical Hospital Centar Zvezdara
  • Kruševac, Serbia, 37000
    • General Hospital Krusevac
  • Niš, Serbia, 18000
    • University Clinical Center Niš
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Clinical Centre of Vojvodina
• South Korea
  • Uijeongbu-si, South Korea
    • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Gyeonggido
    • Seongnam, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggido, South Korea, 16499
      • Ajou University Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 5030
      • Konkuk University Medical Center
• Spain
  • Badalona, Spain, 8916
    • Hospital Universitario Germans Trias i Pujol
  • Badalona, Spain, 8025
    • Fundacio Puigvert
  • Barcelona, Spain, 8035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Barcelona, Spain, 8036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 8003
    • Hospital Del Mar
  • Girona, Spain
    • Hospital Universitari de Girona Dr Josep Trueta
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain
    • Hospital Ruber Juan Bravo (Grupo Quironsalud)
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 220
    • Far Eastern Memorial Hospital
• Ukraine
  • Kyiv, Ukraine
    • Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
  • Kyiv, Ukraine
    • State Institution Institute of Nephrology of NAMS of Ukraine
  • Zaporizhzhia, Ukraine, 69600
    • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
  • Ternopil Oblast
    • Ternopil, Ternopil Oblast, Ukraine, 46002
      • Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
• United States
  • California
    • Oxnard, California, United States, 93030
      • FOMAT Medical Research - FOMAT - HyperCore - PPDS
    • Vacaville, California, United States, 95687
      • Amicis Research Center, Vacaville
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Hospital - Methodist Campus
  • Texas
    • El Paso, Texas, United States, 79935
      • Medresearch Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part 1: Placebo; Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.	Other: Placebo; Placebo comparator
Experimental: Part 1: Felzartamab Dosing Arm M1; Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.	Other: Placebo; Placebo comparator; Drug: Felzartamab; anti-CD38+ monoclonal antibody; Other Names: MOR202
Experimental: Part 1: Felzartamab Dosing Arm M2; Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.	Other: Placebo; Placebo comparator; Drug: Felzartamab; anti-CD38+ monoclonal antibody; Other Names: MOR202
Experimental: Part 1: Felzartamab Dosing Arm M3; Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Drug: Felzartamab; anti-CD38+ monoclonal antibody; Other Names: MOR202
Experimental: Part 2: Japan Cohort; Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.	Drug: Felzartamab; anti-CD38+ monoclonal antibody; Other Names: MOR202

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9	Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria.	Baseline, Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group	All felzartamab and placebo-treated participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only) were divided into exposure quartiles using the sum of measurable felzartamab Ctrough values up to 9 months after the first dose. Percent change from baseline in IgA concentration in these participants was summarized as per each serum concentration quartile.	Up to 9 months
Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose	All participants with evaluable maximum felzartamab concentrations after the first dose were included in the analysis. Cmax values were assessed by infusion-related reaction status after the first dose.	Up to 1 week
Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24	Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR will be estimated based on an MMRM model. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria.	Baseline, Months 3,6,12,18 and 24
Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24	CR was defined as the reduction of proteinuria to less than 0.3 g/g UPCR, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) (at least 80% of value at baseline visit).	Months 3,6,9,12,18 and 24
Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24	Response was defined as reduction of proteinuria to below 0.6 g/g (UPCR) and stable eGFR (at least 80% of value at baseline visit), but not CR.	Months 3,6,9,12,18 and 24
Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24		Months 6, 9,12,18 and 24
Part 1: Duration of Response	Duration of response was defined as date of 1st observation of progressive disease minus date of 1st observation of response+1 day. Duration of response was estimated by Kaplan Meier method.	Up to 2 years
Part 1: Time to Response	Time to response was defined as date of 1st observation of response minus date of randomization+1 day. Time to response was estimated by Kaplan Meier method.	Up to 2 years
Change From Baseline in eGFR Over Time	eGFR was calculated as per the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. eGFR =141×min(Scr/κ, 1)α×max(Scr κ,1)-1.209×0.993Age ×1.018[if female]×1.159 [if black] where: Scr is serum creatinine in μmol/L,; κ is 61.9 for females and 79.6 for males,; α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1 eGFR as a measure of kidney function. eGFR was calculated in terms of milliliter per minute per 1.73 meter square (mL/min/1.73 m^2). A numerically smaller negative change in eGFR indicates a slowing in kidney disease progression.	Baseline, Months 3,6,9,12,15,18, and 24
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)	TEAEs were defined as any AEs reported after the start of trial treatment until 28 days after the last trial treatment, defined as the treatment-emergent period. TESAEs were TEAEs that met the following criteria: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.	From the first dose until 28 days after last dose of study drug (up to 191 days)
Serum Concentrations of Felzartamab Over Time		Predose and 30 minutes post-dose on Days 1, 15, 29; predose on Days 8, 57, 85, 113, 141; Post Treatment Days 169 and 267
Percentage of Participants With Anti- Felzartamab Antibodies	Blood samples were collected for measurement of anti-felzartamab antibodies in the serum. Number of participants with Anti-drug antibody (ADA) status positive/negative was summarized.	From the first dose up to the end of the study (up to 2 years)

Collaborators and Investigators

• Sponsor: HI-Bio, A Biogen Company
• Investigators: Study Director: Medical Director, HI-Bio, A Biogen Company

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Disease; Glomerular Disease; Glomerulonephritis, IGA; Berger Disease; Urologic Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Urologic Diseases; Kidney Diseases; Glomerulonephritis, IGA; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; felzartamab
• Other Study ID Numbers: MOR202C206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No