A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM. The study is designed to follow each participant up to a maximum of 24 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants is starting avapritinib treatment at the HCP's discretion as part of their routine care (for ISM with moderate to severe symptoms inadequately controlled with symptomatic treatment) and in accordance with approved SmPC.
Locations
Other Locations
Germany
Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie
RECRUITING
Dresden
University Medical Center Goettingen - Georg August University of Goettingen
RECRUITING
Göttingen
Universitats-Hautklinik Tubingen, Studienzentrum lmmundermatologie
RECRUITING
Tübingen
Contact Information
Primary
Blueprint Medicines, EU Contact
medinfoeurope@blueprintmedicines.com
+31 85 064 4001
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 80
Treatments
Avapritinib
Participants will receive avapritinib as part of their treatment plan with their healthcare practitioner (HCP) and in accordance with the Summary of Product Characteristics (SmPC).
Related Therapeutic Areas
Sponsors
Leads: Blueprint Medicines Corporation