This is a Phase 3 clinical study investigating the safety and efficacy of a potential treatment for participants with Myelofibrosis (MF) who have suboptimal response while receiving ruxolitinib monotherapy.
Trial ID: NCT04551053
Incyte is committed to expanding the research of investigational treatment options for people with Myelofibrosis (MF). Given that certain populations can respond differently to medical therapies, it is extremely important that this clinical trial include people from all races and ethnicities.![]()
The purpose of this Study is to compare the safety and therapeutic effects of adding parsaclisib (the Study Drug) or placebo to ruxolitinib therapy in patients with MF who continue to have significant enlargement of the spleen and symptoms of MF while on treatment with ruxolitinib only. The first part of the Study is double-blind, which means that you and your Study Doctor will not know if you are receiving Study Drug + ruxolitinib or placebo + ruxolitinib. This Study is also randomized, which means you will be randomly assigned (like flipping a coin) to receive the Study Drug + ruxolitinib or placebo + ruxolitinib. Placebo looks like the Study Drug but contains no medication. After you complete your 24-Week assessments, and if you were assigned to placebo + ruxolitinib, you will have an opportunity to “Crossover” to receive Study Drug + ruxolitinib. You will be in this Study for about 2 years, during which time you cannot participate in other research studies.
We'll check to see if you are eligible by asking you some questions.
What is involved?
You will need to visit a study clinic. A study doctor will provide you with an informed consent and explain the trial. You will then be fully evaluated for participation and eligibility. If eligible, you will be enrolled in the study.
Your participation in the study will be approximately 3 years, and include regular, scheduled visits to the clinical study center. During these visits, you will undergo a physical exam and have blood work performed. A scan (MRI or CT) will be performed at protocol defined frequency during your study participation. Once the study has completed, if you are benefitting from treatment, you will have the option to continue the treatment.
Full details about study treatment, clinic visit schedule and exams will be discussed with you prior to any enrollment.
You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:
Actively Recruiting
Not yet Recruiting
We'll check to see if you are eligible by asking you some questions.