GlomerulonephritisPhase 2NewPLACENCT04733040
Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)
A Phase 2 study testing MOR202 in people with Glomerulonephritis and Membranous Nephropathy, run by HI-Bio, A Biogen Company at 25 sites in 7 countries.
Trial summary
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glomerulonephritis, Membranous Nephropathy, 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
- 24 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 20 Jan 2021to 14 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]).
- Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h
- Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR >30 and < 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of < 25% in a kidney biopsy)
- Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
- Systolic blood pressure (BP) ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest.
- Serum anti-PLA2R antibodies ≥ 50.0 RU/mL determined by Euroimmun ELISA.
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- Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a female of childbearing potential (FCBP)
- A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202
Who cannot join
- Hemoglobin < 80 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.
- Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
- Subjects may receive supportive therapies to meet the above criteria
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- B-cells < 5 x 10^6/L
- Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and diabetes is controlled, as shown by:
- Glycated hemoglobin (HbA1c) <8.0 % or 64 mmol/mol.
- No diabetic retinopathy known.
- No peripheral neuropathy known.
- Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Germany5 sites
University Hospital Aachen
Aachen
Charite
Berlin
DaVita Clinical Research
Düsseldorf
Uniklinikum
Essen
Hospital of Johannes Gutenberg University
Mainz
South Korea5 sites
Hallym University Sacred Heart Hospital
Chuncheon
JeJu National University Hospital
Jeju City
Konkuk University Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Seoul National University Bundang Hospital
Seoul
Taiwan5 sites
Chang Gung Memorial Hospital
Kaohsiung City
Shuang Ho Hospital
New Taipei City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Greece4 sites
General Hospital of Athens
Athens
General Hospital of Heraklion Venizeleio-Papaneio
Heraklion
University General Hospital of Patras
Pátrai
General Hospital of Thessaloniki
Thessaloniki
Georgia2 sites
Managadze National Center of Urology
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi
Russia2 sites
Botkin Hospital Moscow
Moscow
First Pavlov State Medical University of St. Petersburg
Saint Petersburg
United Kingdom2 sites
Kings College
London
Nottingham Renal and Transplant Unit
Nottingham
About this study
Official title: A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy
Read the detailed description
After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months.
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
- Being tested
- MOR202
- Medical subject headings
- Glomerulonephritis, Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR202Drug
Also called Felzartamab
MOR202 will be administered as an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| MOR202 5 Doses | Experimental | 5 doses administered on Day 1, 8, 15, 29, and 57 Receives: Drug: MOR202 |
| MOR202 2 Doses | Experimental | 2 doses administered on Day 1 and 15 Receives: Drug: MOR202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy: percent change of anti-PLA2R antibody levels
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
Measured: 3 months compared to baseline
Secondary outcomes (5)
efficacy: immunological complete response (ICR) rate
efficacy of 2 different dosing regimens of MOR202
Measured: ICR rate at 3 months, 6 months, 12 months and 24 months
efficacy: overall proteinuria response (OPR) rate
efficacy of 2 different dosing regimens of MOR202
Measured: OPR rate at 6 months, 12 months and 24 months.
safety: determined by the frequency, incidence and severity of TEAEs
frequency, incidence and severity of treatment-emergent adverse events
Measured: through treatment completion, an average of 3 months per treatment period
PK profile
MOR202 serum concentrations after multiple i.v. administrations
Measured: through study completion, an average of 1 year
immunogenicity
number of subjects developing anti-MOR202 antibodies
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start20 Jan 2021
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlomerulonephritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04733040
- Sponsor's protocol ID
- MOR202C205
- Acronym
- NewPLACE
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
- ClinicalTrials.gov ID
- NCT04733040
- Acronym / sponsor ID
- NewPLACE / MOR202C205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HI-Bio, A Biogen CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy
Detailed description
After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months.
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOR202 5 Doses | Experimental | Drug: MOR2025 doses administered on Day 1, 8, 15, 29, and 57 |
| MOR202 2 Doses | Experimental | Drug: MOR2022 doses administered on Day 1 and 15 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]).
- Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h
- Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR >30 and < 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of < 25% in a kidney biopsy)
- Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
- Systolic blood pressure (BP) ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest.
Key exclusion criteria (12 listed)
- Hemoglobin < 80 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.
- 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 |
|---|---|---|
| MOR202Also: FelzartamabMOR202 will be administered as an intravenous infusion | Drug | MOR202 2 Doses, MOR202 5 Doses |
Primary outcome
efficacy: percent change of anti-PLA2R antibody levels
Time frame: 3 months compared to baseline
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
5 secondary outcomes
efficacy: immunological complete response (ICR) rate
Time frame: ICR rate at 3 months, 6 months, 12 months and 24 months
efficacy: overall proteinuria response (OPR) rate
Time frame: OPR rate at 6 months, 12 months and 24 months.
safety: determined by the frequency, incidence and severity of TEAEs
Time frame: through treatment completion, an average of 3 months per treatment period
PK profile
Time frame: through study completion, an average of 1 year
immunogenicity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- 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
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOR202 in people with Glomerulonephritis and Membranous Nephropathy, run by HI-Bio, A Biogen Company at 25 sites in 7 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 9 inclusion and 12 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 7 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 25 sites in Germany, South Korea, Taiwan, Greece, Georgia and 2 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy: percent change of anti-PLA2R antibody levels (time frame: 3 months compared to baseline). 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 NCT04733040, 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 7 Feb 2025.