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NCT01250171 · ClinicalTrials.gov registry record · Phase 2
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01250171: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01250171 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250171, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.
Primary Outcome
Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Secukinumab 10 mg/kg
- BIOLOGICAL Canakinumab 10 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT01250171 record still lists
NCT01250171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01250171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01250171 about?
NCT01250171 is a clinical study titled "The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients". This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were...
What is the current status of trial NCT01250171?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2010-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01250171?
The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab 10 mg/kg (BIOLOGICAL), Canakinumab 10 mg/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01250171?
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 NCT01250171's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 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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