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NCT03299686 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT03299686: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03299686 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03299686, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.
Primary Outcome
The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in Liters compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
Interventions
- DRUG CJM112
- OTHER Placebo to CJM112
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2019-07-08 |
| Phase | Phase 2 |
What the finished NCT03299686 record still lists
NCT03299686 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which CJM112 is the first listed.
NCT03299686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03299686 about?
NCT03299686 is a clinical study titled "Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma". An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this s...
What is the current status of trial NCT03299686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2017-11-06. Estimated completion is 2019-07-08.
What interventions are being tested in trial NCT03299686?
The interventions under investigation include: CJM112 (DRUG), Placebo to CJM112 (OTHER).
Who is sponsoring clinical trial NCT03299686?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03299686's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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