Status:
UNKNOWN
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment
Lead Sponsor:
AB Science
Conditions:
Indolent Systemic Mastocytosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Masitinib is a selective tyrosine kinase inhibitor that modulates mast cell activity via inhibition of c-Kit, Lyn and Fyn kinase signaling pathways. This is a multicenter, randomized, double-blind, pl...
Eligibility Criteria
Inclusion
- Patient with one of the following documented mastocytosis subtypes (variants): Smouldering Systemic Mastocytosis, Indolent Systemic Mastocytosis
- An excess of mast cells or a presence of abnormal mast cells in at least two organs (among skin, bone-marrow and GI Tract).
- Patient with documented systemic mastocytosis and evaluable disease based upon histological criteria
- Patient with documented treatment failure of his/her symptom(s) (within the past 2 years) with at least two of the symptomatic treatments used at optimized dose: Anti H1, Anti H2, Proton pump inhibitor, Antidepressants, Cromoglycate Sodium, Antileukotriene.
- Patient with severe symptoms of mastocytosis over the 14-day run-in period including at least one among pruritus, flushes, and depression: pruritus score ≥ 9, number of flushes per week ≥ 8, Hamilton rating scale for depression (HAMD-17) score ≥ 19.
Exclusion
- Patient with one of the following mastocytosis: Cutaneous Mastocytosis, Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM)
- Previous treatment with any Tyrosine Kinase Inhibitor
- Treatment with any investigational agent within 8 weeks prior to screening.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04333108
Start Date
July 1 2020
End Date
June 1 2025
Last Update
May 6 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire d'Amiens
Amiens, France
2
Hospital Jean-Minjoz
Besançon, France
3
Grenoble University Hospital
Grenoble, France
4
Hospital Claude Huriez
Lille, France