AB06006 - Mastocytosis

• Research type

  Research Study

• Full title

  A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap

• IRAS ID

  65715

• Contact name

  Clive Grattan

• Sponsor organisation

  Micron Research

• Eudract number

  2008-000972-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Mastocytosis is a disease characterised by the invasion of specialised immune cells called mast cells into various organs. The skin and bone marrow are usually affected, but other internal organs may also be involved. Severe mastocytosis can affect the patient's quality of life by causing symptoms of itching, difficulty in concentrating, peptic ulcers and diarrhea. It can also lead to life-threatening anaphylactoid reactions and be associated with fatal haematologic disorders. Masitinib is a drug which is under development for the treatment of mastocytosis, as it can inhibit the proliferation of mast cells. The overall purpose of this study is to compare the efficacy and safety of masitinib to placebo in patients with mastocytosis. This study is sponsored by the pharmaceutical company AB Science. Males and females over the age of 18 who meet all inclusion and exclusion criteria and have either smouldering systemic, indolent systemic or cutaneous mastocytosis will be included in the study. 200 patients worldwide will be involved in this study, with 100 receiving masitinib and 100 receiving placebo. Eligible patients will be treated with masitinib or placebo tablets daily for 24 weeks, and attend 15 study visits in this time. Patients will undergo a skin biopsy, blood tests, physical examinations, ECGs, chest X-rays and complete patient questionnaires.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/H0305/7

• Date of REC Opinion

  24 Mar 2011

• REC opinion

  Further Information Favourable Opinion