PHOENYCS GO Lupus Research Study Now Enrolling
Purpose of Study:
The purpose of this study is to assess if the investigational study medication dapirolizumab pegol (DZP), used in addition to your current systemic lupus erythematosus (SLE) medication, may improve your SLE.
What Does this Study Involve?
- The immune system uses antibodies (proteins naturally found in the body) to identify and neutralize foreign objects such as pathogenic bacteria and viruses and appropriately directs the immune response against it.
- In SLE, the immune system is causing inflammation directed against its own body. Antibodies against structures of the immune system’s own body, which are called auto-antibodies, can play a role in this process.
- Dapirolizumab Pegol (DZP) is an antibody. DZP binds to a molecule called CD40 ligand (CD40L), on the surface of many cells of the immune system. This molecule is necessary to facilitate the cell’s interactions and communications. By blocking CD40L, these inflammatory cells cannot mature, activate, or produce autoantibodies thus leading to decreased inflammation. In this study, we are trying to find out if DZP improves the symptoms of SLE.
In this study, at least 450 people in approximately 280 study centers throughout approximately 30 countries worldwide are expected to participate. The study has 3 periods:
- Screening Period (2 weeks before the treatment starts).
- Treatment Period (48 weeks) during which you will receive the experimental treatment or a placebo (define) for the first 44 weeks.
- Safety Follow-up Period (6 weeks).
You may not have a direct health benefit from participating in this study. DZP is an experimental drug and there is no guarantee that your SLE will get better with DZP. In addition, instead of DZP, you may receive a placebo and your SLE medication.
However, those taking DZP may improve your active SLE activity.
The information from this study may help researchers to learn more about the safety and tolerability of DZP. Further data from this study may also serve to understand SLE better and how to treat it better.
Who may participate in this study?
You or your child may be eligible for this research study, if the following applies to one of you:
- You are at least 16 years old
- One of you have persistent or relapsing burdensome symptoms of your SLE under your current SLE medication
There are other requirements. A final decision on whether this research study might be suitable for you or your child will be made after you speak with the study doctor at the research site. The study doctor will explain the benefits and risks of participation in this research study.
Reimbursement and expenses
- You will not be paid for taking part in this study. You can receive reimbursement for travel costs for this study.
- You will receive all study-related care at no cost. This includes the study drug as well as any visits to your study doctor’s office.
Interventional Clinical Trial
Learn More by visiting: Lupus (clinlife.com)
Choosing to participate in a study is an important personal decision. Be sure to have an open conversation with your doctor. It is important to understand all of your options before deciding what is right for you. Choosing to be in a clinical trial is voluntary. For more information about clinical trials, visit our Featured Research Studies page.