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

NCT05065970 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MOR202C206
• Study Type: interventional
• Target: 54
• Locations: 15 countries
• Sites: 59

Brief Summary

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

Conditions

Immunoglobulin A (IgA) Nephropathy

Keywords

Kidney Disease; Urologic Disease; Glomerular Disease; Berger Disease; Glomerulonephritis, IGA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group

  Up to 9 months

• Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) 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

  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

  Months 3,6,9,12,18 and 24

• Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24

  Months 3,6,9,12,18 and 24

Study Arms (5)

Part 1: Placebo

PLACEBO COMPARATOR

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

Part 1: Felzartamab Dosing Arm M1

EXPERIMENTAL

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.

Drug: Felzartamab; Other: Placebo

Part 1: Felzartamab Dosing Arm M2

EXPERIMENTAL

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.

Drug: Felzartamab; Other: Placebo

Part 1: Felzartamab Dosing Arm M3

EXPERIMENTAL

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

Part 2: Japan Cohort

EXPERIMENTAL

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

Interventions

Felzartamab DRUG

anti-CD38+ monoclonal antibody

Also known as: MOR202

Part 1: Felzartamab Dosing Arm M1; Part 1: Felzartamab Dosing Arm M2; Part 1: Felzartamab Dosing Arm M3; Part 2: Japan Cohort

Placebo OTHER

Placebo comparator

Part 1: Felzartamab Dosing Arm M1; Part 1: Felzartamab Dosing Arm M2; Part 1: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HI-Bio, A Biogen Company: lead

Study Sites (59)

FOMAT Medical Research - FOMAT - HyperCore - PPDS

Oxnard, California, 93030, United States

Location

Amicis Research Center, Vacaville

Vacaville, California, 95687, United States

Location

Mayo Clinic Hospital - Methodist Campus

Rochester, Minnesota, 55902, United States

Location

MedResearch INC

El Paso, Texas, 79935, United States

Location

Core Research Group

Milton, Queensland, 4064, Australia

Location

Sunshine Hospital - Australia

Saint Albans, Victoria, Australia

Location

Imelda VZW

Bonheiden, Antwerpen, Belgium

Location

UZ Leuven Hospital

Leuven, Vlaams Brabant, 3000, Belgium

Location

Regionaal Ziekenhuis Jan Yperman VZW

Ieper, Belgium

Location

CHU Sart Tilman Hospital

Liège, 4000, Belgium

Location

Diagnostic- Consultative Center Convex EOOD

Sofia, Sofia-Grad, 1680, Bulgaria

Location

Medical Center Hera EOOD, Montana

Montana, 3400, Bulgaria

Location

Medical Center Hipokrat- N EOOD

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Stara Zagora, Bulgaria

Location

Nemocnice AGEL Novy Jicin a.s

Nový Jicín, Moravian-Silesian Region, 741 01, Czechia

Location

Eticka komise Fakultni nemocnice Olomouc

Olomouc, Olomouc Region, 775 20, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady Hospital

Prague, Praha, Hlavní Mesto, 10034, Czechia

Location

Vseobecna Fakultni Nemocnice V Praze

Prague, Praha, Hlavní Mesto, 128 08, Czechia

Location

JSC Evex Hospitals

Tbilisi, 121, Georgia

Location

L. Managadze National Center of Urology LTD

Tbilisi, 144, Georgia

Location

Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies

Tbilisi, 144, Georgia

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, 260-0801, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaidô, 060-8648, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-Shi, Hukuoka, 807-8556, Japan

Location

Kurume University Hospital

Kurume-Shi, Hukuoka, 830-0011, Japan

Location

Fukushima Medical University Hospital

Fukushima, Hukusima, 960-1295, Japan

Location

JCHO Sendai Hospital

Sendai, Miyagi, 981-3205, Japan

Location

Japanese Red Cross Ashikaga Hospital

Ashikaga-Shi, Tochigi, 326-0843, Japan

Location

Juntendo University Hospital

Bunkyō-Ku, Tokyo, 113-8431, Japan

Location

Osaka University Hospital

Suita-Shi, Ôsaka, 565-0871, Japan

Location

University Malaya Medical Centre

Pantai, Malaysia

Location

St Frances Cabrini Medical Center and Cancer Institute

Santo Tomas, Batangas, 4234, Philippines

Location

Clinical Centre of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

Clinical Hospital Centar Zvezdara

Belgrade, Serbia

Location

General Hospital Krusevac

Kruševac, 37000, Serbia

Location

University Clinical Center Nis

Niš, 18000, Serbia

Location

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggido, 16499, South Korea

Location

Konkuk University Medical Center

Seoul, Seoul Teugbyeolsi, 5030, South Korea

Location

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Fundacio Puigvert

Badalona, 8025, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, 8916, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Ruber Juan Bravo (Grupo Quironsalud)

Madrid, Spain

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council

Ternopil, Ternopil Oblast, 46002, Ukraine

Location

Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"

Kyiv, Ukraine

Location

State Institution Institute of Nephrology of NAMS of Ukraine

Kyiv, Ukraine

Location

Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

Zaporizhzhia, 69600, Ukraine

Location

Related Publications (4)

• 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.

  PMID: 40581166 DERIVED

• 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.

  PMID: 40465397 DERIVED

• 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.

  PMID: 38299639 DERIVED

• 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.

  PMID: 37772889 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Urologic Diseases; Glomerulonephritis, IGA

Interventions

felzartamab

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  HI-Bio, A Biogen Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 4, 2021
• Study Start: August 31, 2021
• Primary Completion: February 6, 2023
• Study Completion: May 6, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (4); TW (3); GE (3); US (4); PH (1); CZ (4); SE (5); BE (4); BU (4); MY (1); DE (3); JP (9); AU (2); UA (4); ES (8)