While there are treatments that help some people manage their PPP symptoms, there are currently no approved treatments that specifically address PPP. For this reason, medical researchers are exploring treatment options that could help reduce or prevent PPP symptoms.
This study will evaluate the effectiveness and safety of an injectable investigational drug for patients who have been diagnosed with PPP. Researchers want to compare different doses of the investigational drug to placebo, which looks like the investigational drug but has no active ingredient.
The investigational drug has not been approved by any regulatory authority for the treatment of PPP or any other disease, and at this time, it is only available in clinical research studies like this one.
The results from this study will provide more information about the investigational drug and whether it could be used to effectively and safely treat this condition in the future.
All study-related care and the investigational drug will be provided ar no cost to you. In addition, reimbursement for study-related time and travel may be provided.
If you are eligible for this study and you agree to participate, you will be randomly assigned (like the flip of a coin) to one of the five groups. Four groups will receive injections of the investigational drug, and one group will receive a placebo. You have about a 71% chance of receiving the investigational drug and a 29% chance of receiving a placebo.You, the study doctor, and the study staff will not know your study group assignment. However, in the event of an emergency, this information can be provided.
No matter which group you are in you will be given four subcutaneous injections (needle is inserted just beneath the skin) of the study drug (investigational or placebo) at each dosing visit. Injections will be given weekly for the first four weeks of the study. After the first four weeks, you will receive the injections every four weeks for 48 weeks.
Your total study participation will last approximately 72 weeks (about 17 months), which includes up to 20 visits to the study clinic for tests and assessments.
As with any clinical research study, there is no guarantee you will benefit from participation. However. your participation may help people with PPP in the future.
It is also possible you could experience side effects while in this study. Before you begin, the study staff will review a full list of risks and possible side effects with you.
Because research studies can affect the health of participants, you will be monitored during your participation in this study. The sponsor of this study was required to design a protocol, which explains all study activities in detail. An independent review board (IRB) is responsible for participant safety and has reviewed and approved this protocol. The IRB requires that it be followed by the study doctor and study staff exactly.
