AB15003 Phase III Masitinib vs Placebo in Mastocytosis Patients V1.0
Research type
Research Study
Full title
A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety of oral masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment.
IRAS ID
215432
Contact name
Alain Moussy
Contact email
Sponsor organisation
AB Science
Eudract number
2016-001447-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137036, IND Number
Duration of Study in the UK
3 years, 7 months, 0 days
Research summary
This is a clinical trial investigating if the study drug (masitinib) is effective and safe to treat participants who have smouldering or indolent severe systemic mastocytosis where previous treatments have not been successful. Each participant should expect to be in the study for at least 24 weeks.
Masitinib blocks biochemical processes involved in inflammation and the immune responses. The sponsor of the study has performed three previous clinical trials, these results support the use of masitinib in the treatment of mastocytosis.
The study will be conducted at different hospitals in different countries and participants will be assigned randomly to receive one of two treatments. One group will receive the study drug (masitinib) and the other group will receive placebo (a tablet that contains no drug). Neither the doctors, nurses nor the participants will know which treatment is being given.
Participants will take the study tablets (masitinib or placebo) every day at a low dose for the first 4 weeks. If they feel o.k. and it is safe to do so, the number of study tablets will be increased after 4 weeks and again after 8 weeks.
The study can include both male and female participants between the ages of 18 - 75 years if they also meet the eligibility criteria set for the study.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0040
Date of REC Opinion
19 Feb 2021
REC opinion
Further Information Favourable Opinion