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Masitinib for the Treatment of Severe Mast Cell Activation Syndrome

NCT05449444 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Mast Cell Activation Syndrome

Interventions

DRUG

Masitinib 4.5 mg/kg/day

Masitinib 4.5 mg/kg/day

DRUG

Placebo

Matching placebo

OTHER

Best supportive care

Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, sodium cromoglicate, antidepressants, antileukotrienes, proton pump inhibitors, and corticosteroids.

DRUG

Masitinib 6.0 mg/kg/day

Masitinib 6.0 mg/kg/day

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449444 on ClinicalTrials.gov