Phase 3 study Masitinib/Placebo in severe persistent Asthma V1

• Research type

  Research Study

• Full title

  A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids

• IRAS ID

  165593

• Contact name

  Alain Moussy

• Contact email

  a.moussy@ab-science.com

• Sponsor organisation

  AB Science

• Eudract number

  2010-020803-63

• Clinicaltrials.gov Identifier

  NCT01449162

• Clinicaltrials.gov Identifier

  RESP 3627, Study assigned to specialist Network

• Duration of Study in the UK

  2 years, 8 months, 29 days

• Research summary

  Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. It is believed that airway inflammation is the critical element in the development of asthma which promotes airway hyper-responsiveness and airway obstruction. This hyper-responsiveness leads to recurrent episode of wheezing, chest tightness, breathlessness and coughing particular at night or in the early morning.

  Medical scientists have established that different allergens initiate the inflammatory process by activating IgE (a proteins that circulate in the blood) -bearing pulmonary mast cells (MC; a type of cell found in blood). This inflammation may then become persistent, and thereby perpetuate the asthmatic symptoms. Increased mast cells number in airways may be linked to airways hyper-responsiveness. Therefore targeting mast cells could be an ideal remedy for this disease.

  Asthma is a disease generally well controlled by inhaled treatments, bronchodilators and/or corticosteroids. However, an average 5-10% of the patients remain uncontrolled with these treatments and are in need of oral corticosteroids, which can induce severe side effects and for that reason should be avoided. These patients are therefore in high need of treatments targeting specifically asthma inflammation.
  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 effectively be used in the patients with severe persistent asthma.

  This phase 3 study is being carried out in 300 patients with severe persistent asthma treated with oral corticosteroids, to compare the effectiveness and safety of masitinib (a tablet) at 6 mg/kg/day to placebo (identical-looking dummy tablet).

  Patients will be randomly chosen to go into 2 groups for different treatments and will be treated for 36-weeks.

  •Group 1: 200 patients will receive masitinib at 6 mg/kg/day
  •Group 2: 100 patients will receive placebo

  A placebo (no drug) treatment arm is required to accurately compare the disease progression of patients who have received Masitinib.

  Run-In Phase:
  Patient fulfilling the inclusion/exclusion criteria will enter a Run-In period for two-week. This will serve as the reference period for evaluating patient conditions

  Initial Treatment Phase (W0-W36):
  Patients who fulfil randomisation criteria will be randomised and will enter the 36-weeks treatment period.During the 36-weeks period, patients will receive either masitinib at the fixed dose of 6 mg/kg/day or its matching placebo.

  Oral Corticosteroids weaning Phase (W36-W44):
  Only patients treated with > 15 mg/day of prednisone (corticosteroid drug) at week 36 will enter an 8-week follow up oral corticosteroid sparing period. During this period, initial oral corticosteroid dose will be decreased of 25% every week until a worsening of asthma occurs. As soon as a patient experiences a worsening of asthma, investigator should reintroduce the corticosteroid at the dose of the previous week. No further corticosteroid dose reduction should take place.

  Extension phase:
  At week 36 for patients receiving =15mg/day of prednisone or at week 44 for patients receiving >15 mg/day of prednisone can enter a treatment extension phase if judged medically appropriate by the investigator (refer to follow-up section), for a maximum treatment exposure of 2 years. After 2 years, patients will be allowed to continue the treatment on a case by case basis only if a documented favourable benefit/risk ratio is established by the investigator.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  15/EE/0075

• Date of REC Opinion

  16 Jul 2015

• REC opinion

  Further Information Favourable Opinion