Masitinib vs placebo in the treatment of moderate Crohn’s disease-V1.0
Research type
Research Study
Full title
A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors
IRAS ID
171161
Contact name
Alain Moussy
Contact email
Sponsor organisation
AB Science
Eudract number
2012-004222-25
Clinicaltrials.gov Identifier
GAST 3552, Study assigned to specialist Network
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
Crohn’s disease is a chronic inflammation of the bowel that may affect any part of the gastrointestinal tract from mouth to anus. Symptoms of Crohn’s disease often include: abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever and weight loss. The exact cause of Crohn’s disease is unknown, but suggested possibilities include genetic, environmental, immunologic, and infectious causes.
Medical scientists have established that Crohn’s disease involves an immune system dysfunction and an imbalance between cell signals that maintain the process of inflammation. It is widely believed that mast cells (a type of cell found in blood) play an important role in Crohn’s disease due to their extraordinary ability to release inflammatory cytokines (cell signals) that have been shown to be involved in the inflammatory course of the disease. Because, mast cells appear to play a central role in Crohn’s disease, targeting mast cells could be an ideal treatment for this disease.
Masitinib (the drug under study) is already being developed as an anti-inflammatory agent and has been shown to inhibit (slow down) the function of mast cells and therefore may reduce the progression of Crohn’s disease.
This phase 2b/3 study is being carried out in 450 patients with Crohn’s disease, to compare the effectiveness and safety of masitinib (a tablet) to placebo (dummy tablet), in treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors.
Patients will be randomly chosen to go into 2 groups for different treatments:
Group 1: 3 mg/kg/day during 4 weeks, then 4.5 mg/kg/day during 4 weeks and then 6 mg/kg/day, and [Azathioprine or 6-mercaptopurine or methotrexate] (225 patients)
Group 2: placebo with the same administration plan as masitinib and [Azathioprine or 6-mercaptopurine or methotrexate] (225 patients)REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0465
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion