Best supportive care for Mast Cell Activation Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St Charles Clinical Research, Weldon Spring, MO
Mast Cell Activation Syndrome+2 More
Best supportive care - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness and safety of two different doses of masitinib, compared to placebo, in treating patients with severe MCAS who have not responded well to other treatments. Best supportive care is a treatment that is used to help manage symptoms of Mast Cell Activation Syndrome. This type of care has been previously approved by the FDA for another condition.

Eligible Conditions

  • Mast Cell Activation Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mast Cell Activation Syndrome

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: week 8 to week 24

24 weeks
Confirmed response (75%)
Confirmed response at 50%
Patient-Reported Outcome for Symptom Severity (PROSS)
Week 24
Cumulative response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Mast Cell Activation Syndrome

Trial Design

3 Treatment Groups

Masitinib (4.5) & BSC
1 of 3
Masitinib (6.0) & BSC
1 of 3
Placebo & BSC
1 of 3
Experimental Treatment
Non-Treatment Group

72 Total Participants · 3 Treatment Groups

Primary Treatment: Best supportive care · Has Placebo Group · Phase 2

Masitinib (4.5) & BSCExperimental Group · 2 Interventions: Masitinib 4.5 mg/kg/day, Best supportive care · Intervention Types: Drug, Other
Masitinib (6.0) & BSCExperimental Group · 2 Interventions: Masitinib 6.0 mg/kg/day, Best supportive care · Intervention Types: Drug, Other
Placebo & BSCPlaceboComparator Group · 2 Interventions: Placebo, Best supportive care · Intervention Types: Drug, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 8 to week 24
Closest Location: St Charles Clinical Research · Weldon Spring, MO
Photo of missouri 1Photo of missouri 2Photo of missouri 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Mast Cell Activation Syndrome
0 CompletedClinical Trials

Who is running the clinical trial?

AB ScienceLead Sponsor
36 Previous Clinical Trials
8,050 Total Patients Enrolled
Julien Rossignol, MDPrincipal InvestigatorReference Centre for Mastocytosis (CEREMAST), Necker Hospital, Paris, France

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are on a stable dose of antihistamine for a minimum of 4 weeks before screening and should remain at a stable dose throughout the study period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.