Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.


Clinical Trial Description

This was a prospective, multicenter, randomized, placebo-controlled, parallel-group, phase 3 study, conducted in 15 countries, evaluating the efficacy and safety of masitinib (6 mg/kg/day administered orally in two daily intakes over 24-weeks with a double-blind extension period possible) for the treatment of indolent systemic mastocytosis, smoldering mastocytosis or cutaneous mastocytosis, in patients with mast cells mediator release symptoms that are refractory to conventional symptomatic treatment.

A study protocol amendment restricted enrolment to patients with severe indolent and smoldering systemic mastocytosis. The objective of this phase 3 study was therefore to evaluate masitinib efficacy and safety in severe systemic mastocytosis patients, with or without D816V mutation of c-Kit. The primary objective of the phase 3 study was to detect a statistically significant difference between masitinib (plus optimal concomitant symptomatic treatments) and placebo (plus optimal concomitant symptomatic treatments) in cumulative response on four severe symptoms, referred to also as handicaps. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00814073
Study type Interventional
Source AB Science
Contact
Status Completed
Phase Phase 3
Start date December 2008
Completion date November 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04655118 - Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis Phase 2
Recruiting NCT04910685 - (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis Phase 2/Phase 3
Completed NCT03632811 - Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language
Completed NCT02808793 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002 Phase 1
Completed NCT02478957 - Treatment of Indolent Systemic Mastocytosis With PA101 Phase 2
Completed NCT03770273 - Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis Phase 2
Recruiting NCT04333108 - Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment Phase 3
Not yet recruiting NCT06210698 - Angioedema Biomarker Research Study
Active, not recruiting NCT01920204 - Midostaurin in Indolent Systemic Mastocytosis Phase 2
Active, not recruiting NCT03731260 - (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis Phase 2