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

H

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

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

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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