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

PHASE3UnknownINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

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.

Trial Locations (17)

Unknown

RECRUITING

Centre Hospitalier Universitaire d'Amiens, Amiens

RECRUITING

Hospital Jean-Minjoz, Besançon

RECRUITING

Grenoble University Hospital, Grenoble

RECRUITING

Hospital Claude Huriez, Lille

RECRUITING

Marseille University Hospital Timone, Marseille

RECRUITING

Centre de référence de Mastocytose (CEREMAST), Paris

RECRUITING

Poitiers University Hospital, Poitiers

RECRUITING

Centre Hospitalier Universitaire, Toulouse

NOT_YET_RECRUITING

University Hospital Charité, Berlin

RECRUITING

Erasmus University Medical Center, Rotterdam

RECRUITING

Medical University of Gdańsk, Gdansk

RECRUITING

The University Hospital in Krakow (Szpital Uniwersytecki w Krakowie), Krakow

RECRUITING

University Hospital in Bucharest (Spitalul Universitar de Urgență București), Bucharest

RECRUITING

Almazov National Medical Research Centre, Saint Petersburg

RECRUITING

Dnipropetrovsk Clinical Association of Emergency Medical Care of Dnipropetrovsk Regional, Dnipro

RECRUITING

Private Enterprise Private Manufacturing Company Acinus, Poltava

RECRUITING

Guy's and St Thomas' NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AB Science

INDUSTRY