EN 
ES 
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
IGNAZ
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 - IGNAZ
Brief Description
The IGNAZ Study is looking at the safety and effectiveness of Felzartamab in adults 18 to 80 years old with IgA nephropathy. Researchers want to compare different doses of Felzartamab to see which one might be better than taking no medicine at all.
Address
Sponsor
MorphoSys AG
Study Drug
MOR202/Felzartamab
Estimated enrollment
44
Estimated end date
Last patient last visit January 2024
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
IGNAZ
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 - IGNAZ
Brief Description
The IGNAZ Study is looking at the safety and effectiveness of Felzartamab in adults 18 to 80 years old with IgA nephropathy. Researchers want to compare different doses of Felzartamab to see which one might be better than taking no medicine at all.
Trial is for people with
IgA nephropathy
Study Goal
IGNAZ seeks to investigate an innovative treatment option for IgA Nephropathy
What is involved for the Patient?
During the study you would first be screened to make sure you are eligible for treatment. If so, you would be placed by chance in a group to receive one of the Felzartamab or placebo doses. A placebo looks like the study treatment but has no actual medicine in it. A placebo is used to evaluate any potential difference in the benefits and side effects of felzartamab. The medicine and placebo are given as intravenous (IV) infusions, which means they are given slowly through a small needle in the arm. Each participant would receive a total of 9 infusions. You would also continue to take your current standard medicine (for example, blood pressure pills).
The study lasts a little over 2 years with 17 visits for tests. It comprises the screening period, treatment period and follow-up period in which you will allow the sponsor to access your medical history and biosamples such as blood and urine and perhaps biopsy tissue will be collected.
About the drug or intervention
Felzartamab belongs to a group of medicines called “monoclonal antibodies”, proteins designed to attach to specific cells or substances in the body. Felzartamab is designed to attach to the cells that produce the antibody in your body and subsequently reduce unwanted auto-antibodies considered responsible for the development of IgA nephropathy.
