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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    625
  • sponsor
    Novartis Pharmaceuticals
Updated on 18 May 2022
corticosteroids

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.

Description

This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625 patients will be randomized into this study.

Details
Condition Asthma
Treatment Placebo, CSJ117
Clinical Study IdentifierNCT04410523
SponsorNovartis Pharmaceuticals
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Patients who have a cigarette smoking history of greater than 10 pack years or current smokers or vapers
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, untreated and not cured hepatitis C or HIV
Patients who discontinued monoclonal antibodies (investigational or approved) for asthma due to lack of efficacy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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