Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
Public ClinicalTrials.gov record NCT04946318. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 24-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Extension Study to Assess the Safety of CSJ117, When Added to Existing Standard of Care Asthma Therapy in Patients ≥18 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04946318
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 136 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2021 (Actual)
- Primary completion
- Sep 8, 2022 (Actual)
- Completion
- Sep 8, 2022 (Actual)
- Last update posted
- Oct 10, 2022
2021 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Bakersfield | California | 93301 | — |
| Novartis Investigative Site | Huntington Beach | California | 92647 | — |
| Novartis Investigative Site | Los Angeles | California | 90017 | — |
| Novartis Investigative Site | Los Angeles | California | 90025 | — |
| Novartis Investigative Site | Marietta | Georgia | 30060 | — |
| Novartis Investigative Site | White Marsh | Maryland | 21162 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | — |
| Novartis Investigative Site | Greenville | South Carolina | 29607 | — |
| Novartis Investigative Site | Boerne | Texas | 78006 | — |
| Novartis Investigative Site | McKinney | Texas | 75069 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04946318, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04946318 live on ClinicalTrials.gov.