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NCT04910685 · ClinicalTrials.gov registry record · Phase 2
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
A Phase 2 study of Indolent Systemic Mastocytosis and Smoldering Systemic Mastocytosis, sponsored by Blueprint Medicines Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 534
- Enrollment target
- 20
- Study locations
NCT04910685: Recruiting Phase 2 study of Indolent Systemic Mastocytosis and Smoldering Systemic Mastocytosis, sponsored by Blueprint Medicines Corporation.
NCT04910685 is a Phase 2 study of Indolent Systemic Mastocytosis and Smoldering Systemic Mastocytosis that is actively recruiting participants, run by Blueprint Medicines Corporation. The registered enrollment target is 534 participants, above the 169-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target (216% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04910685, a Phase 2 study of Indolent Systemic Mastocytosis and Smoldering Systemic Mastocytosis, is actively recruiting participants, sponsored by Blueprint Medicines Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 534 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elenestinib
Study Locations (20)
Other
- Kepler Universitatsklinikum, Med Campus III. Clinic of Internal Medicine 3 - Hematology and Oncology - Linz
- CHU Amiens-Picardie - Amiens
- CHU de Caen - Caen
California
- David Geffen School of Medicine at UCLA - Los Angeles
- Stanford Cancer Institute - Palo Alto
New York
- Roswell Park Cancer Institute - Buffalo
- Columbia University Medical Center - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- UCHealth Blood Disorders and Cell Therapies Center - Anschutz Medical Campus - Aurora
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- Michigan Medicine University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 2 |
What NCT04910685 shows while recruiting
NCT04910685 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target (216% higher).
The record links to 2 conditions, with Indolent Systemic Mastocytosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04910685 names 20 study sites across 16 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04910685 about?
NCT04910685 is a clinical study titled "(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis". This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts ...
What is the current status of trial NCT04910685?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 534 participants. The study started on 2021-11-30. Estimated completion is 2032-09-30.
What conditions does trial NCT04910685 study?
This clinical trial studies the following conditions: Indolent Systemic Mastocytosis, Smoldering Systemic Mastocytosis.
What interventions are being tested in trial NCT04910685?
The interventions under investigation include: Placebo (DRUG), Elenestinib (DRUG).
Who is sponsoring clinical trial NCT04910685?
This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04910685 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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