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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT04410523

Run by

Novartis Pharmaceuticals

People needed

335

Starts

2020-09-09

Expected to finish

2022-09-06

Last updated by the study team

2024-06-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 until 12 weeks after last study drug treatment
• Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.

Where it is running

• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Mission Viejo, California, United States
• Novartis Investigative Site — San Jose, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Bangor, Maine, United States
• Novartis Investigative Site — White Marsh, Maryland, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — Columbia, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Greenville, South Carolina, United States
• Novartis Investigative Site — Boerne, Texas, United States
• Novartis Investigative Site — McKinney, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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