Trial · NCT04145440
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
NCT04145440, Phase 1, Phase 2, Completed, HI-Bio, A Biogen Company; results first posted 2024-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN). Trials, record NCT04145440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04145440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
- NCT number
- NCT04145440
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- HI-Bio, A Biogen Company
- Conditions
- Glomerulonephritis, Membranous, antiPLA2R Positive
- Interventions
- MOR202
- First posted
- 2019-10-30
- Last updated
- 2025-02-24
- Results first posted
- 2024-12-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. |
| Primary | Percentage of Participants With Adverse Events | 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. |
| Secondary | Best Immunological Response Rate (BIRR) | Up to 52 weeks | 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. |
| Secondary | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | |
| Secondary | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | |
| Secondary | Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | |
| Secondary | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | 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) | |
| Secondary | Number of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | 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. |
| Secondary | Percentage of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Week 1 to Week 24 | The Safety Analysis Set included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Adverse Events | Week 1 to Week 24 | The Safety Analysis Set included all participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Best Immunological Response Rate (BIRR) | Up to 52 weeks | The FAS included all participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | The Immunogenicity Analysis Set (IAS) included all participants with at least one antidrug antibody (ADA) result available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | The IAS included all participants with at least one ADA result available. | percentage of participants | NUMBER |
| SECONDARY | Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies | Baseline; Up to 52 weeks | The IAS included all participants with at least one ADA result available. Here, the Overall Number of Participants Analyzed equals the number of participants with positive ADA titers and Number Analyzed is the number of participants evaluable at each time point. | anti-felzartamab antibody titers | MEAN |
| SECONDARY | Felzartamab Serum Concentrations After Multiple Intravenous Administrations | 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) | The Pharmacokinetic Analysis Set (PKAS) included all participants with evaluable felzartamab serum concentration data. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and the Number Analyzed shows the number of participants evaluated at each time point. | nanogram(s)/millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | The Safety Analysis Set included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With AEs During the Follow-up Period | Week 25 to Week 52 | The Safety Analysis Set included all participants who received at least one dose of study drug | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 15 | Participants | ||
| Number of Participants With Adverse Events | Cohort 2 (Refractory Participants) | 12 | Participants | ||
| Percentage of Participants With Adverse Events | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 83.3 | percentage of participants | ||
| Percentage of Participants With Adverse Events | Cohort 2 (Refractory Participants) | 92.3 | percentage of participants | ||
| Best Immunological Response Rate (BIRR) | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 83.3 | 95% Confidence Interval 58.6 to 96.4 | percentage of participants | |
| Best Immunological Response Rate (BIRR) | Cohort 2 (Refractory Participants) | 61.5 | 95% Confidence Interval 31.6 to 86.1 | percentage of participants | |
| Number of Participants Tested Positive for Anti-felzartamab Antibodies | Cohort 1 (Newly Diagnosed or Relapsed Participants) | Baseline | 1 | Participants | |
| Number of Participants Tested Positive for Anti-felzartamab Antibodies | Cohort 2 (Refractory Participants) | Baseline | 1 | Participants | |
| Number of Participants Tested Positive for Anti-felzartamab Antibodies | Cohort 1 (Newly Diagnosed or Relapsed Participants) | Post First Dose (52 weeks) | 1 | Participants | |
| Number of Participants Tested Positive for Anti-felzartamab Antibodies | Cohort 2 (Refractory Participants) | Post First Dose (52 weeks) | 0 | Participants |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 18 | |
| Overall Study | STARTED | Cohort 2 (Refractory Participants) | 13 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 18 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cohort 2 (Refractory Participants) | 13 | |
| Overall Study | COMPLETED | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 13 | |
| Overall Study | COMPLETED | Cohort 2 (Refractory Participants) | 10 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Newly Diagnosed or Relapsed Participants) | 5 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Refractory Participants) | 3 |
Source ClinicalTrials.gov
Adverse events424
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aortic aneurysm | Vascular disorders | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 0 | 18 | |
| other | Aortic aneurysm | Vascular disorders | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 1 | 13 | |
| other | Aortic aneurysm | Vascular disorders | Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52) | 0 | 18 | |
| other | Aortic aneurysm | Vascular disorders | Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52) | 0 | 13 | |
| other | Hypertension | Vascular disorders | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 0 | 18 | |
| other | Hypertension | Vascular disorders | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 1 | 13 | |
| other | Hypertension | Vascular disorders | Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52) | 0 | 18 | |
| other | Hypertension | Vascular disorders | Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52) | 1 | 13 | |
| other | Venous thrombosis limb | Vascular disorders | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 0 | 18 | |
| other | Venous thrombosis limb | Vascular disorders | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 1 | 13 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 0 | 18 |
| Total, all-cause mortality | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 0 | 13 |
| Total, all-cause mortality | Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52) | 0 | 18 |
| Total, all-cause mortality | Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52) | 0 | 13 |
| Total, other adverse events | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 15 | 18 |
| Total, other adverse events | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 12 | 13 |
| Total, other adverse events | Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52) | 8 | 18 |
| Total, other adverse events | Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52) | 5 | 13 |
| Total, serious adverse events | Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24) | 2 | 18 |
| Total, serious adverse events | Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24) | 3 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40465397 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (Newly Diagnosed or Relapsed Participants) vs Cohort 2 (Refractory Participants): Number of Participants With AEs During the Follow-up Period | Trial comparisons |
| Cohort 1 (Newly Diagnosed or Relapsed Participants) vs Cohort 2 (Refractory Participants): Number of Participants With Adverse Events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04145440
GET https://conductscience.org/api/trials/v1/NCT04145440/results?page=2