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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065970
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

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

Condition or disease Intervention/treatment Phase
Immunoglobulin A (IgA) Nephropathy Drug: Felzartamab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Placebo comparator

Experimental: Felzartamab Arm #1 Drug: Felzartamab
anti-CD38+ monoclonal antibody
Other Name: MOR202

Experimental: Felzartamab Arm #2 Drug: Felzartamab
anti-CD38+ monoclonal antibody
Other Name: MOR202

Experimental: Felzartamab Arm #3 Drug: Felzartamab
anti-CD38+ monoclonal antibody
Other Name: MOR202




Primary Outcome Measures :
  1. Efficacy: Relative change in Proteinuria value [ Time Frame: 9 months compared to baseline ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065970


Contacts
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Contact: Morphosys Clinical Program Lead +498989927 ext 0 MOR202C206-CPL@morphosys.com

Locations
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Sponsors and Collaborators
MorphoSys AG
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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT05065970    
Other Study ID Numbers: MOR202C206
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MorphoSys AG:
Kidney Disease
Urologic Disease
Glomerular Disease
Berger Disease
Glomerulonephritis, IGA
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Felzartamab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs