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

Phase 2

Completed

• Conditions: Immunoglobulin A (IgA) Nephropathy
• Interventions: Other: Placebo; Drug: Felzartamab

• Registration Number: NCT05065970
• Lead Sponsor: HI-Bio, A Biogen Company

Brief Summary

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

Detailed Description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Primary Completion: 2023-02-06
• Disposition First Submitted: 2024-02-02
• Disposition First Posted: 2024-02-06
• Study Completion: 2024-05-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Felzartamab Arm #2	Felzartamab	-
Felzartamab Arm #1	Felzartamab	-
Felzartamab Arm #3	Felzartamab	-

Primary Outcome Measures

Name	Time	Method
Efficacy: Relative change in Proteinuria value	9 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic: serum concentrations of Felzartamab over time	Ongoing through treatment completion, up to 2 years
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

Trial Locations

Locations (60)

FOMAT Medical Research - FOMAT - HyperCore - PPDS; 🇺🇸 Oxnard, California, United States

Amicis Research Center, Vacaville; 🇺🇸 Vacaville, California, United States

Mayo Clinic Hospital - Methodist Campus; 🇺🇸 Rochester, Minnesota, United States

MedResearch INC; 🇺🇸 El Paso, Texas, United States

Core Research Group; 🇦🇺 Milton, Queensland, Australia

Sunshine Hospital - Australia; 🇦🇺 Saint Albans, Victoria, Australia

Imelda VZW; 🇧🇪 Bonheiden, Antwerpen, Belgium

UZ Leuven Hospital; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Regionaal Ziekenhuis Jan Yperman VZW; 🇧🇪 Ieper, Belgium

CHU Sart Tilman Hospital; 🇧🇪 Liège, Belgium

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