RECRUITING

Masitinib for the Treatment of Severe Mast Cell Activation Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.

Official Title

A 24-week, Multicenter, Randomized, Double Blind, Placebo-controlled, Dose-range Finding Phase II Study to Compare Efficacy and Safety of Oral Masitinib to Placebo in Treatment of Patients With Severe Mast Cell Activation Syndrome (MCAS) With Handicap Unresponsive to Optimal Symptomatic Treatment

Quick Facts

Study Start:2022-07-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05449444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Study Coordinator
CONTACT
+33(0)147200014
clinical@ab-science.com

Principal Investigator

Julien Rossignol, MD
PRINCIPAL_INVESTIGATOR
Reference Centre for Mastocytosis (CEREMAST), Necker Hospital, Paris, France

Study Locations (Sites)

St Charles Clinical Research
Weldon Spring, Missouri, 63304
United States

Collaborators and Investigators

Sponsor: AB Science

  • Julien Rossignol, MD, PRINCIPAL_INVESTIGATOR, Reference Centre for Mastocytosis (CEREMAST), Necker Hospital, Paris, France

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Mast Cell Activation Syndrome