Last updated on April 2019

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

  • Informed consent and assent (if applicable).
  • Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
  • Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

  • Written informed consent.
  • A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of 85% of the predicted normal value.
  • An ACQ score 1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
  • Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
  • Inability to comply with all study requirements.
  • Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:

  • Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
  • Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).
  • A QTcF (Fridericia) 450 msec (male) or 460 msec (female).
  • History of malignancy with the exception of local basal cell carcinoma of the skin
  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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