At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 259 enrolled
Drug / intervention
Humira® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
VOLTAIRE-X: Pharmacokinetics, Safety, Immunogenicity and Efficacy of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: a Randomized, Double-blind, Parallel-arm, Multiple-dose, Active Comparator Trial
In Brief
A Phase 3 clinical trial evaluating Humira® and BI 695501 for Psoriasis. Completed, enrolled 259 participants across 49 sites in 7 countries.
Detailed 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®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesGermany, Hungary, Latvia, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartJul 2017
Primary CompletionApr 2019
TodayJul 2026
First PostedJul 6, 2017
Enrollment StartJul 10, 2017
Primary CompletionApr 16, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago
Interventions
Humira®drug
Duration - 58 weeks
BI 695501drug
Duration - 58 weeks