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NCT03210259 · ClinicalTrials.gov registry record · Phase 3
The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 259
- Enrollment target
NCT03210259: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT03210259 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 259 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03210259, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 259 participants
- Enrollment target
Study Summary
The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis. The secondary objectives of this trial are to descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®.
Primary Outcome
Area Under the Plasma Concentration Time Curve Over the 2 weeks dosing Interval between Week 30 to 32 (AUCτ, 30-32) for Adalimumab in plasma was reported.
Interventions
- DRUG BI 695501
- DRUG Humira®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2019-04-16 |
| Phase | Phase 3 |
What the finished NCT03210259 record still lists
NCT03210259 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which BI 695501 is the first listed.
NCT03210259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03210259 about?
NCT03210259 is a clinical study titled "The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis". The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis. The secondary objectives of this trial are to descriptively compare t...
What is the current status of trial NCT03210259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2017-07-10. Estimated completion is 2019-04-16.
What interventions are being tested in trial NCT03210259?
The interventions under investigation include: BI 695501 (DRUG), Humira® (DRUG).
Who is sponsoring clinical trial NCT03210259?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03210259's enrollment target sits among peer trials
259 1234th of 2000 higher than 766 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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