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

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ClinicalTrials.gov Identifier: NCT04145440
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : March 23, 2021
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 : October 2021
Estimated Study Completion Date : May 2022

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 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 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



Information from the National Library of Medicine

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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:

  • > 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
  • 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 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.

Key Exclusion Criteria:

  • 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

  • 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).

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


Contacts
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Contact: Bettina Schwamb, PhD +498989927 ext 0 MOR202C103-CPL@morphosys.com
Contact: Goran Babic, MD +498989927 ext 0 MOR202C103-CPL@morphosys.com

Locations
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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: March 23, 2021
Last Verified: March 2021
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