Glomerulonephritis, MembranousPhase 1/2M-PLACENCT04145440
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
A Phase 1/2 study testing MOR202 in people with Glomerulonephritis, Membranous and antiPLA2R Positive, run by HI-Bio, A Biogen Company at 45 sites in 9 countries.
Trial summary
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glomerulonephritis, Membranous, antiPLA2R Positive
- What is being tested?
- MOR202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 45 sitesin 9 countries
- Study dates
- 15 Oct 2019to 2 Aug 2022
- Phase
- Phase 1/2
- 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
- > 18 to < 80 years (at date of signing informed consent form [ICF]).
- Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
- Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
- Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and <50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
- Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
- Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest
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- Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
- Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL
- Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening
- Note: France will only enroll patients in Cohort 2.
Who cannot join
- Hemoglobin < 80 g/L.
- Thrombocytopenia: Platelets < 100.0 x 109/L.
- Neutropenia: Neutrophils < 1.5 x 109/L.
- Leukopenia: Leukocytes < 3.0 x 109/L.
- Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
- Subjects may receive supportive therapies to meet the above criteria
Show all 9Show fewer
- B-cells < 5 x 106/L.
- Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
- Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
United States11 sites
North America Research Institute
Azusa, California, 91702
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
MedResearch, Inc
El Paso, Texas, 79905
Texas Research Institute
Fort Worth, Texas, 76248
GA Nephrology Associates
Lawrenceville, Georgia, 30046
University of Miami Division of Nephrology & Hypertension
Miami, Florida, 33136
Mayo Clinic
Rochester, Minnesota, 55902
UCSF Medical Center
San Francisco, California, 94143
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101
Kidney Care and Transplant Services of New England, PC
Springfield, Massachusetts, 01107
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Spain8 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Universitario Reina Sofia
Córdoba, 50134
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28222
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Dr. Peset
Valencia, 46017
Belgium6 sites
O.L.V. Ziekenhuis
Aalst, 9300
C.H.U. Brugmann - Site Victor Horta
Brussels, 1020
Universitair Ziekenhuis Brussels
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
France5 sites
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, 33000
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, 38043
Hopital Claude Huriez -CHU Lille
Lille, 59037
Hopital Tenon Service de nephrologie
Paris, 75020
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42055
South Korea5 sites
Chungnam National University Hospital
Daejeon, 35015
Hallym University Kangdong Sacred Heart Hospital
Seoul, 05355
Gangnam Severance Hospital
Seoul, 06273
The Catholic University of Korea
Seoul, 06591
Severance Hospital, Yonsei University Health System
Seoul
Australia3 sites
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Western Health
Melbourne, 3021
St. George Hospital
Sydney, New South Wales, 2217
Italy3 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale San Raffaele
Milan, 20132
Ospedale Borgo Roma
Verona, 37124
Poland3 sites
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 92213
Centrum Zdrowia MDM
Warsaw, 00631
Miedzyleski Szpital Specjalistyczny
Warsaw, 04749
About this study
Official title: A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)
Read the detailed description
After treatment subjects will be observed for up to 1 year.
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
- Conditions
- Glomerulonephritis, Membranous, antiPLA2R Positive
- Being tested
- MOR202
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR202Drug
Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (newly diagnosed or relapsed participants) | Experimental | Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. Receives: Drug: MOR202 |
| Cohort 2 (refractory participants) | Experimental | Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. Receives: Drug: MOR202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Week 1 to Week 24
Percentage of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Week 1 to Week 24
Secondary outcomes (7)
Best Immunological Response Rate (BIRR)
The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.
Measured: Up to 52 weeks
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Measured: Baseline; Up to 52 weeks
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Measured: Baseline; Up to 52 weeks
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Measured: Baseline; Up to 52 weeks
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Measured: Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
Number of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Week 25 to Week 52
Percentage of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Week 25 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 Oct 2019
- Primary completion19 Jan 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 2 cohorts by disease status (Cohort 1: Patients with newly diagnosed or relapsed membranous nephropathy; Cohort 2: Patients with membranous nephropathy refractory to immunosuppressive treatment)
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- HI-Bio, A Biogen Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, HI-Bio, A Biogen Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145440
- Sponsor's protocol ID
- MOR202C103
- Acronym
- M-PLACE
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2019
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)
- ClinicalTrials.gov ID
- NCT04145440
- Acronym / sponsor ID
- M-PLACE / MOR202C103
- Conditions
- Glomerulonephritis, Membranous, antiPLA2R Positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- HI-Bio, A Biogen CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)
Detailed description
After treatment subjects will be observed for up to 1 year.
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 cohorts by disease status (Cohort 1: Patients with newly diagnosed or relapsed membranous nephropathy; Cohort 2: Patients with membranous nephropathy refractory to immunosuppressive treatment)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (newly diagnosed or relapsed participants) | Experimental | Drug: MOR202Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
| Cohort 2 (refractory participants) | Experimental | Drug: MOR202Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- > 18 to < 80 years (at date of signing informed consent form [ICF]).
- Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
- Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
- Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and <50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
- Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
Key exclusion criteria (9 listed)
- Hemoglobin < 80 g/L.
- Thrombocytopenia: Platelets < 100.0 x 109/L.
- Neutropenia: Neutrophils < 1.5 x 109/L.
- Leukopenia: Leukocytes < 3.0 x 109/L.
- Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOR202Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. | Drug | Cohort 1 (newly diagnosed or relapsed participants), Cohort 2 (refractory participants) |
Primary outcome
Number of Participants With Adverse Events
Time frame: Week 1 to Week 24
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Percentage of Participants With Adverse Events
Time frame: Week 1 to Week 24
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as 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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
7 secondary outcomes
Best Immunological Response Rate (BIRR)
Time frame: Up to 52 weeks
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Time frame: Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
Number of Participants With AEs During the Follow-up Period
Time frame: Week 25 to Week 52
Percentage of Participants With AEs During the Follow-up Period
Time frame: Week 25 to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40465397Ahmad 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.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
HI-Bio, A Biogen Company
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MOR202 in people with Glomerulonephritis, Membranous and antiPLA2R Positive, run by HI-Bio, A Biogen Company at 45 sites in 9 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 10 inclusion and 9 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Spain, Belgium, France, South Korea and 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Dec 2024). 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?
Number of Participants With Adverse Events (time frame: Week 1 to Week 24). The study lists 2 primary outcomes in all. 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 NCT04145440, which also lists 1 linked publication.
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 24 Feb 2025.