HIB-202-101 Clinical Research Study

This clinical research study is testing an investigational medication for adults with lupus nephritis. The goal of the study is to see if the study medication can help with symptoms of lupus nephritis and stop the condition from getting worse.The study medication, known as felzartamab, is a monoclonal antibody, which is an antibody that is made in a laboratory. This antibody is designed to block the activity of cells that attack the kidneys in lupus nephritis. This may help improve your symptoms and prevent the condition from getting worse.The study medication is investigational. This means that it has not been approved by any health or regulatory authorities and can only be used in clinical research studies.

Who can join the study?

You may be eligible to join the study if you meet the following requirements*

  • 18 to 75 years old

  • Diagnosis of Class 3 or 4 lupus nephritis (with or without Class 5)

  • Lack of response to standard of care therapies for lupus nephritis

You may receive:

  • Close supervision by specialists

  • Compensation for time and travel

  • Snacks and refreshments

  • Medical screening and blood test

WHAT ARE CLINICAL TRIALS?

Clinical research is a vital part of medical science that involves conducting studies to explore new treatments, therapies, and diagnostic methods. By participating in clinical research, you can contribute to the development of better treatments and potentially benefit from cutting-edge therapies. It's an opportunity to receive expert medical care and access to new treatments that are not yet widely available. For those with kidney diseases, joining a clinical study could offer new avenues for managing your condition and improving your quality of life.

  • Participants may gain access to new treatments before they are widely available, receive expert medical care at leading healthcare facilities during the trial, and contribute to medical research that may benefit others.

  • As with any medical treatment, there are potential risks. These may include side effects from the treatment, procedures that may be uncomfortable or time-consuming, and the possibility that the new treatment may not be effective.

  • Compensation for participation varies depending on the study. Some trials provide financial compensation, while others may offer travel reimbursements or free medical treatment. Details about compensation will be provided before enrollment.

  • After a trial is completed, the data is analyzed to determine the effectiveness and safety of the intervention. Results are often published in scientific journals and may lead to further research or the development of new treatments.

  • Clinical trials are conducted in phases, each with a different purpose. Phase I tests safety and dosage, Phase II evaluates effectiveness and side effects, Phase III compares the new treatment against current treatments, and Phase IV occurs after FDA approval to monitor long-term effectiveness and safety.

  • Yes, participation in clinical trials is voluntary, and participants can withdraw at any time for any reason without penalty or loss of benefits to which they are otherwise entitled.

  • Determining your eligibility for a clinical trial involves evaluating various factors such as your age, health condition, medical history, and specific criteria related to the study. To find out if you qualify for any of our current or upcoming clinical trials, we encourage you to fill out our online screener. This screener is a simple questionnaire that helps us assess your suitability for a trial based on preliminary information. Once completed, our team will review your responses and get in touch with you to discuss potential trial opportunities that you may be eligible for.