For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country
  2. Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
  3. Proteinuria at screening visit ≥ 1.0 g/d.
  4. 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.
  5. 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

  1. Hemoglobin < 90 g/L
  2. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
  3. Neutropenia: Neutrophils < 1.5 x 10^9/L.
  4. Leukopenia: Leukocytes < 3.0 x 10^9/L
  5. Diabetes mellitus type 1
  6. Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +498989927Email iconEmail Study Center

Study’s details


Contition

Immunoglobulin A (IgA) Nephropathy

Age (in years)

18 - 80

Phase

Phase 2

Participants needed

54

Est. Completion Date

May 2024

Treatment type

Interventional


Sponsor

HI-Bio

ClinicalTrials.gov identifier

NCT05065970

Study number

MOR202C206

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