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NCT02134028 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,282
- Enrollment target
NCT02134028: Completed Phase 3 study, sponsored by Sanofi.
NCT02134028 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 2,282 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (196% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02134028, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,282 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers
Primary Outcome
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untowa
Interventions
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,282 participants |
| Start Date | 2014-08-05 |
| Est. Completion | 2019-10-11 |
| Phase | Phase 3 |
What the finished NCT02134028 record still lists
NCT02134028 is an interventional study that assigns participants to a tested intervention. Its 2,282 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (196% higher).
The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.
NCT02134028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02134028 about?
NCT02134028 is a clinical study titled "Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)". Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with ...
What is the current status of trial NCT02134028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,282 participants. The study started on 2014-08-05. Estimated completion is 2019-10-11.
What interventions are being tested in trial NCT02134028?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT02134028?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02134028's enrollment target sits among peer trials
2,282 94th of 2000 higher than 1,907 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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