Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy

Study Overview
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Brief Summary
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Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN

Official Title
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A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy

Conditions
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Immunoglobulin A (IgA) Nephropathy

Intervention / Treatment
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* Drug: Felzartamab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF Proteinuria at screening visit ≥ 1.0 g/d. Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control. A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP Key Exclusion Criteria: Hemoglobin < 90 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 Diabetes mellitus type 1 Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo comparator<br>|
| Experimental: Felzartamab Arm #1<br> | Drug: Felzartamab<br>* anti-CD38+ monoclonal antibody<br>* Other names: MOR202;|
| Experimental: Felzartamab Arm #2<br> | Drug: Felzartamab<br>* anti-CD38+ monoclonal antibody<br>* Other names: MOR202;|
| Experimental: Felzartamab Arm #3<br> | Drug: Felzartamab<br>* anti-CD38+ monoclonal antibody<br>* Other names: MOR202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Relative change in Proteinuria value |  | 9 months compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: determined by the frequency, incidence and severity of TEAEs |  | Ongoing through study completion, up to 2 years | 
| Efficacy: Relative change in proteinuria value |  | Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years | 
| Efficacy: complete response in patients with IgAN |  | Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years | 
| Pharmacokinetic: serum concentrations of Felzartamab over time |  | Ongoing through treatment completion, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Disease, Urologic Disease, Glomerular Disease, Berger Disease, Glomerulonephritis, IGA