Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

Key facts

Study ID

NCT04946318

Run by

Novartis Pharmaceuticals

People needed

136

Starts

2021-09-08

Expected to finish

2022-09-08

Last updated by the study team

2022-10-10

Who can join

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

You may qualify if…

• All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
• Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C.

You may not qualify if…

• Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
• Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.
• Participants receiving any prohibited medications.
• Participants with a history or current diagnosis of ECG abnormalities.
• Pregnant or nursing (lactating) women.

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 — Marietta, Georgia, United States
• Novartis Investigative Site — White Marsh, Maryland, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, 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 — Ranelagh, Partido de Berazate, Buenos Aires, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Mendoza, Argentina
• Novartis Investigative Site — Paraná, Argentina
• Novartis Investigative Site — Erpent, Belgium
• Novartis Investigative Site — Rousse, Bulgaria
• Novartis Investigative Site — Stara Zagora, Bulgaria
• Novartis Investigative Site — Burlington, Ontario, Canada
• Novartis Investigative Site — Etobicoke, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Teplice, CZE, Czechia
• Novartis Investigative Site — Lovosice, Czechia
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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