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Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment

NCT04333108 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.

Conditions

  • Indolent Systemic Mastocytosis

Interventions

DRUG

Masitinib

Masitinib 6 mg/kg/day

OTHER

Placebo

Matching placebo

OTHER

Best Supportive Care

Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglycate, antidepressants, leukotriene antagonists and corticosteroids.

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Cristina Bulai Livideanu, MD, MSc · Centre Hospitalier Universitaire, Service de Dermatologie, Toulouse -France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • France
  • Germany
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT04333108 on ClinicalTrials.gov