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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT04145440
• Date of registration: 18/10/2019
• Prospective Registration: No
• Primary sponsor: HI-Bio, A Biogen Company
• Public title: Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) M-PLACE
• Scientific 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)
• Date of first enrolment: October 15, 2019
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04145440
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, Belgium, France, Italy, Korea, Republic of, Netherlands, Poland, Spain, United States

Contacts

• Name: HI-Bio Clinical Program Lead
• Affiliation: HI-Bio, A Biogen Company

Key inclusion & exclusion 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 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.

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).


Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

antiPLA2R Positive

Glomerulonephritis, Membranous

Intervention(s)

Drug: MOR202

Primary Outcome(s)

Percentage of Participants With Adverse Events [Time Frame: Week 1 to Week 24]

Number of Participants With Adverse Events [Time Frame: Week 1 to Week 24]

Secondary Outcome(s)

Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies [Time Frame: Baseline; Up to 52 weeks]

Best Immunological Response Rate (BIRR) [Time Frame: Up to 52 weeks]

Number of Participants With AEs During the Follow-up Period [Time Frame: Week 25 to Week 52]

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]

Percentage of Participants With AEs During the Follow-up Period [Time Frame: Week 25 to Week 52]

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)]

Secondary ID(s)

MOR202C103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/12/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04145440