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

HI-Bio

Status and phase: Completed; Phase 2

Conditions: Immunoglobulin A (IgA) Nephropathy

Treatments: Other: Placebo; Drug: Felzartamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05065970

MOR202C206

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Felzartamab Arm #1

Experimental group

Treatment:

Drug: Felzartamab

Felzartamab Arm #2

Experimental group

Treatment:

Drug: Felzartamab

Felzartamab Arm #3

Experimental group

Treatment:

Drug: Felzartamab