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Immunoglobulin A (IgA) NephropathyPhase 2IGNAZNCT05065970

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

A Phase 2 study testing Felzartamab in people with Immunoglobulin A (IgA) Nephropathy, run by HI-Bio, A Biogen Company at 59 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Immunoglobulin A (IgA) Nephropathy
What is being tested?
Felzartamab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
59 sitesin 15 countries
Study dates
31 Aug 2021to 6 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

59 sites in 15 countries.

59 sites in 15 countries

Japan9 sites

  • Japanese Red Cross Ashikaga Hospital

    Ashikaga-Shi, Tochigi, 326-0843

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo, 113-8431

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-0801

  • Fukushima Medical University Hospital

    Fukushima, Hukusima, 960-1295

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-Shi, Hukuoka, 807-8556

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011

  • Hokkaido University Hospital

    Sapporo, Hokkaidô, 060-8648

  • JCHO Sendai Hospital

    Sendai, Miyagi, 981-3205

  • Osaka University Hospital

    Suita-Shi, Ôsaka, 565-0871

Other trials in Japan

Spain8 sites

  • Fundacio Puigvert

    Badalona, 8025

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 8916

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Ruber Juan Bravo (Grupo Quironsalud)

    Madrid

Other trials in Spain

Serbia5 sites

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Hospital Centar Zvezdara

    Belgrade

  • General Hospital Krusevac

    Kruševac, 37000

  • University Clinical Center Nis

    Niš, 18000

  • Clinical Centre of Vojvodina

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

United States4 sites

  • MedResearch INC

    El Paso, Texas, 79935

  • FOMAT Medical Research - FOMAT - HyperCore - PPDS

    Oxnard, California, 93030

  • Mayo Clinic Hospital - Methodist Campus

    Rochester, Minnesota, 55902

  • Amicis Research Center, Vacaville

    Vacaville, California, 95687

Other trials in United States

Belgium4 sites

  • Imelda VZW

    Bonheiden, Antwerpen

  • Regionaal Ziekenhuis Jan Yperman VZW

    Ieper

  • UZ Leuven Hospital

    Leuven, Vlaams Brabant, 3000

  • CHU Sart Tilman Hospital

    Liège, 4000

Other trials in Belgium

Bulgaria4 sites

  • Medical Center Hera EOOD, Montana

    Montana, 3400

  • Medical Center Hipokrat- N EOOD

    Plovdiv, 4000

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, Sofia-Grad, 1680

  • University Multiprofile Hospital for Active Treatment

    Stara Zagora

Other trials in Bulgaria

Czechia4 sites

  • Nemocnice AGEL Novy Jicin a.s

    Nový Jicín, Moravian-Silesian Region, 741 01

  • Eticka komise Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 775 20

  • Fakultni nemocnice Kralovske Vinohrady Hospital

    Prague, Praha, Hlavní Mesto, 10034

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, Praha, Hlavní Mesto, 128 08

Other trials in Czechia

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido, 13620

  • Konkuk University Medical Center

    Seoul, Seoul Teugbyeolsi, 5030

  • Ajou University Hospital

    Suwon, Gyeonggido, 16499

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

    Uijeongbu-si

Other trials in South Korea

Ukraine4 sites

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

    Kyiv

  • State Institution Institute of Nephrology of NAMS of Ukraine

    Kyiv

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

    Ternopil, Ternopil Oblast, 46002

  • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

    Zaporizhzhya, 69600

Other trials in Ukraine

Georgia3 sites

  • JSC Evex Hospitals

    Tbilisi, 121

  • L. Managadze National Center of Urology LTD

    Tbilisi, 144

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

    Tbilisi, 144

Other trials in Georgia

Germany3 sites

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz

Other trials in Germany

Taiwan3 sites

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Taichung Veterans General Hospital

    Taichung, 407

  • Far Eastern Memorial Hospital

    Taipei, 220

Other trials in Taiwan

Australia2 sites

  • Core Research Group

    Milton, Queensland, 4064

  • Sunshine Hospital - Australia

    Saint Albans, Victoria

Other trials in Australia

Malaysia1 site

  • University Malaya Medical Centre

    Pantai

Other trials in Malaysia

Philippines1 site

  • St Frances Cabrini Medical Center and Cancer Institute

    Santo Tomas, Batangas, 4234

Other trials in Philippines

About this study

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

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

Read the detailed description

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

Being tested
Felzartamab, Placebo
Keywords
Kidney Disease, Urologic Disease, Glomerular Disease, Berger Disease, Glomerulonephritis, IGA
Medical subject headings
Kidney Diseases, Urologic Diseases, Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FelzartamabDrug

    Also called MOR202

    anti-CD38+ monoclonal antibody

  • PlaceboOther

    Placebo comparator

Study groups in NCT05065970
Study groupRoleWhat they receive
Part 1: PlaceboPlacebo comparatorParticipants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
Receives: Other: Placebo
Part 1: Felzartamab Dosing Arm M1ExperimentalParticipants 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.
Receives: Drug: Felzartamab; Other: Placebo
Part 1: Felzartamab Dosing Arm M2ExperimentalParticipants 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.
Receives: Drug: Felzartamab; Other: Placebo
Part 1: Felzartamab Dosing Arm M3ExperimentalParticipants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
Receives: Drug: Felzartamab
Part 2: Japan CohortExperimentalJapanese 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.
Receives: Drug: Felzartamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 9

Secondary outcomes (12)

  1. 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.

    Measured: Up to 9 months

  2. 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.

    Measured: Up to 1 week

  3. 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.

    Measured: Baseline, Months 3,6,12,18 and 24

  4. 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).

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

  5. 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.

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

  6. Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24

    Measured: Months 6, 9,12,18 and 24

  7. 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.

    Measured: Up to 2 years

  8. 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.

    Measured: Up to 2 years

  9. 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.

    Measured: Baseline, Months 3,6,9,12,15,18, and 24

  10. 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.

    Measured: From the first dose until 28 days after last dose of study drug (up to 191 days)

  11. Serum Concentrations of Felzartamab Over Time

    Measured: 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

  12. 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.

    Measured: From the first dose up to the end of the study (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start31 Aug 2021
  3. Primary completion6 Feb 2023
  4. Study completion6 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065970
Sponsor's protocol ID
MOR202C206
Acronym
IGNAZ
Status last verified
Apr 2026
First submitted
14 Sep 2021
Last updated
28 Apr 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • 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.

    PubMed 40581166

  • 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.

    PubMed 40465397

  • Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.

    PubMed 40444214

  • 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.

    PubMed 38299639

  • 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.

    PubMed 37772889

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Felzartamab in people with Immunoglobulin A (IgA) Nephropathy, run by HI-Bio, A Biogen Company at 59 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Japan, Spain, Serbia, United States, Belgium and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 (time frame: Baseline, Month 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065970, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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