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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 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.

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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

Indolent Systemic Mastocytosis Smoldering Systemic Mastocytosis

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

FieldValue
Enrollment Target 534 participants
Start Date 2021-11-30
Est. Completion 2032-09-30
Phase Phase 2

Sponsor

Blueprint Medicines Corporation

24 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04910685

The ClinicalTrials.gov registry entry for NCT04910685 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 169-participant average among 3 other Indolent Systemic Mastocytosis trials with a reported enrollment target (216% higher). The listed sponsor is Blueprint Medicines Corporation, which has 24 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.