Thank you for your interest in the HARBOR study.
We appreciate your support in helping us learn how we can improve health outcomes in patients who are living with ISM or smoldering systemic mastocytosis.
For your patients who are living with indolent systemic mastocytosis
The HARBOR study is researching whether the investigational drug elenestinib is safe and effective in treating indolent systemic mastocytosis (ISM) in adults.
In this study, researchers want to learn
The HARBOR study will also include two exploratory groups that will enable the researchers to learn more about the effects of the study drug in participants who have
Please consider encouraging your eligible patients to participate in the phase 2/3 HARBOR study of elenestinib.
Please visit harborclinicaltrial.com to refer your eligible patients. You can learn more about the HARBOR study at clinicaltrials.gov by searching for NCT04910685. For more information, please email us at medinfo@blueprintmedicines.com or call us at 1-888-BLUPRNT.
We appreciate your support in helping us learn how we can improve health outcomes in patients who are living with ISM or smoldering systemic mastocytosis.
The HARBOR study will be conducted at study sites around the world, including North America, Europe, and Australia. The study is expected to enroll approximately 350 participants who have indolent systemic mastocytosis (ISM) for a 48-week placebo-controlled treatment period, followed by an open-label extension period in which all participants will receive elenestinib. The open-label extension period will continue for at least 4 years. The total time for the HARBOR study is approximately 5 years.
The HARBOR study will determine whether elenestinib and symptom-directed therapy (SDT) are more efficacious than placebo and SDT in reducing the total symptom score on the Indolent Systemic Mastocytosis-Symptom Assessment Form, based on the mean change from baseline to 48 weeks.
To determine whether elenestinib and SDT are more efficacious than placebo and SDT in
To evaluate the safety and tolerability of elenestinib as determined by adverse events, serious adverse events, and changes in safety laboratory parameters, vital signs, and electrocardiogram evaluations.
To be eligible for the study, patients must
* Additional inclusion criteria apply.
For more information, contact Blueprint Medicines.
Patients who meet any of the following criteria will be ineligible to participate in the study:
* Additional exclusion criteria apply.
For more information, contact Blueprint Medicines.
Thank you for your interest in the HARBOR study!