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Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (M-PLACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04145440
Recruitment Status : Suspended (Study recruitment paused due to COVID-19 pandemic)
First Posted : October 30, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Brief 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)

Condition or disease Intervention/treatment Phase
Glomerulonephritis, Membranous antiPLA2R Positive Drug: MOR202 Phase 1 Phase 2

Detailed Description:
After treatment subjects will be observed for up to 1 year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 2 cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: MOR202
9 doses of MOR202 will be administered as an intravenous infusion at 16 mg/kg over 6 treatment cycles at 28-days each. Dosing occurs weekly in cycle 1 (C1) and every four weeks in cycles 2-6.
Drug: MOR202
9 doses of MOR202 will be administered as an intravenous infusion at 16 mg/kg over 6 treatment cycles at 28-days each, weekly in C1 and every 4 weeks C2-6.




Primary Outcome Measures :
  1. safety and tolerability: incidence and severity of treatment-emergent adverse events [ Time Frame: at end of treatment phase (after 6 months) ]
    incidence and severity of treatment-emergent adverse events


Secondary Outcome Measures :
  1. effect of MOR202 on serum anti-PLA2R antibodies [ Time Frame: through study completion, an average of 1 year ]
    best Immunological Response based on reduction of serum anti-PLA2R antibody titer

  2. immunogenicity of MOR202 [ Time Frame: through study completion, an average of 1 year ]
    number of subjects developing anti-MOR202 antibodies

  3. PK profile [ Time Frame: through study completion, an average of 1 year ]
    serum concentrations after multiple i.v. administrations

  4. safety in the follow-up phase: incidence and severity of adverse events (AEs) in the follow-up phase [ Time Frame: through study completion, an average of 1 year ]
    incidence and severity of adverse events (AEs) in the follow-up phase


Other Outcome Measures:
  1. clinical efficacy: effect of MOR202 treatment on reduction of proteinuria [ Time Frame: at end of treatment phase (end of cycle 6) and end of study (after 12 months) ]
    number of subjects achieving a complete response or a partial response based on reduction of proteinuria

  2. QoL: KDQOL-36 [ Time Frame: at defined time points through study completion, last after 1 year ]
    defined as score change from baseline as assessed by KDQOL-36

  3. kinetics of anti-PLA2R antibody titers [ Time Frame: through study completion, an average of 1 year ]
    anti-PLA2R antibody titer % change from baseline to each visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Urine protein to creatinine ratio of ≥3.0 g/g (as measured from a 24 hour urine collection)
  • Active anti-PLA2R antibody positive MN in need for 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.
  • on supportive treatment with an Angiotensin Converting Enzyme Inhibitor or an Angiotensin II Receptor Blocker for at least 4 weeks prior to Screening, having reached a stable dose.
  • Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg
  • Vaccinated against Pneumococcus within the last 3 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 1a (newly diagnosed patients): Serum anti-PLA2R antibodies ≥150.0 Response Units(RU)/mL determined at screening by Euroimmun ELISA.
  • Cohort 1b, relapse subjects: Must have had complete immunological and/or clinical remission according to judgement of the investigator and serum anti-PLA2R antibodies ≥50.0 RU/mL determined at screening by Euroimmun ELISA.
  • Cohort 2: Failure of previous therapy, i.e. subject never achieved a complete immunological and/or clinical remission according to judgement of the investigator. during or after completion of a recognized IST containing cyclosporine A, tacrolimus, mycophenolate-mofetil, ACTH or alkylating agents (e.g. cyclophosphamide), or rituximab. Serum anti-PLA2R antibodies ≥20.0 RU/mL determined at screening by the Euroimmun ELISA.

Key Exclusion Criteria:

  • Hemoglobin <90 g/L.
  • Thrombocytopenia: Platelets <100.0x109/L.
  • Neutropenia: Neutrophils <1.5x109/L.
  • Leukopenia: Leukocytes <3.0x109/L .
  • Hypogammaglobulinemia: Serum immunoglobulins ≤5.0 g/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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145440


Locations
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United States, California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Belgium
O.L.V. Ziekenhuis
Aalst, Belgium, 9300
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
CHU de Liège
Liège, Belgium, 4000
France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, France, 33000
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, France, 38043
Hopital Claude Huriez -CHU Lille
Lille, France, 59037
Hopital Tenon Service de nephrologie
Paris, France, 75020
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France, 42055
Italy
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50134
Netherlands
Radboud UMC Niimegen Nephrology
Nijmegen, Netherlands, 6525 GA
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia
Córdoba, Spain, 50134
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sponsors and Collaborators
MorphoSys AG
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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT04145440    
Other Study ID Numbers: MOR202C103
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glomerulonephritis
Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases