Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosed asthma

• Male and female patients aged >18 and <75 years

• Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers

• Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal

• A positive reversibility test

• ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

• History of at least 1 asthma exacerbations within the 12 months prior to Screening Visit that required treatment with systemic corticosteroids (tablets, suspension or injection).

Exclusion Criteria:

• Patients who have a cigarette smoking history of greater than 10 pack years or current smokers.

• Pregnant or nursing (lactating) women

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and one week after last study drug treatment

• Patients with a history of immunodeficiency disease or hepatitis B or hepatitis C or HIV.