Informations générales (source: ClinicalTrials.gov)
A 24-week, Multicenter, Randomized, Double Blind, Placebo-controlled, Dose-range Finding Phase II Study to Compare Efficacy and Safety of Oral Masitinib to Placebo in Treatment of Patients With Severe Mast Cell Activation Syndrome (MCAS) With Handicap Unresponsive to Optimal Symptomatic Treatment
Interventional
Phase 2
AB Science (Voir sur ClinicalTrials)
juillet 2022
décembre 2024
08 février 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire Amiens-Picardie - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria include:
- Patient with mast cell activation syndrome (MCAS).
- Patient with severe symptoms over the 14-day run-in period defined as at least one
of the following: Pruritus score ≥ 9; Number of flushes per week ≥ 8; Hamilton
rating scale for depression (HAMD-17) score ≥ 19
- Patient with documented treatment failures of his/her handicap(s) (within last two
years) with at least two of the symptomatic treatments used at optimized dose.
- Patients must be on a stable dose of Anti-H1 for a minimum of 4 weeks before
screening and should remain at a stable dose throughout the study period.
Exclusion Criteria include:
- Previous treatment with any Tyrosine Kinase Inhibitor.
- Any change in the symptomatic treatment of MCAS, including systemic corticosteroids,
or administration of any new treatment for MCAS within 4 weeks prior to screening.
- Patient with systemic indolent mastocytosis.
- Female patients who are pregnant or are breastfeeding.
- Patient with mast cell activation syndrome (MCAS).
- Patient with severe symptoms over the 14-day run-in period defined as at least one
of the following: Pruritus score ≥ 9; Number of flushes per week ≥ 8; Hamilton
rating scale for depression (HAMD-17) score ≥ 19
- Patient with documented treatment failures of his/her handicap(s) (within last two
years) with at least two of the symptomatic treatments used at optimized dose.
- Patients must be on a stable dose of Anti-H1 for a minimum of 4 weeks before
screening and should remain at a stable dose throughout the study period.
Exclusion Criteria include:
- Previous treatment with any Tyrosine Kinase Inhibitor.
- Any change in the symptomatic treatment of MCAS, including systemic corticosteroids,
or administration of any new treatment for MCAS within 4 weeks prior to screening.
- Patient with systemic indolent mastocytosis.
- Female patients who are pregnant or are breastfeeding.