Phase 3
Completed N=259
The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT03210259 ↗Enrolled (actual)
259
Serious AEs
3.0%
Results posted
Jul 2021
Primary outcomePrimary: Area Under the Plasma Concentration Time Curve Over the Dosing Interval of Week 30 to 32 (AUCτ, 30-32) for Adalimumab in Plasma — 2040; 1980 microgram * hours / milliliter
◆ Published Evidence
Established
27citations · ~7 / year
Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.
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®.
Linked Publications
-
Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Time Curve Over the Dosing Interval of Week 30 to 32 (AUCτ, 30-32) for Adalimumab in Plasma |
2040; 1980 | — |
| PRIMARY Maximum Observed Concentration During the Dosing Interval Week 30-32 (Cmax, 30-32) for Adalimumab in Plasma |
7.13; 7.14 | — |
| SECONDARY Minimum Observed Concentration During the Dosing Interval of Week 30 to 32 (Cmin, 30-32) for Adalimumab in Plasma |
5.04; 4.66 | — |
| SECONDARY Time to Maximum Observed Concentration During the Dosing Interval of Week 30 to 32 (Tmax, 30-32) for Adalimumab in Plasma |
72.7; 72.3 | — |
| SECONDARY Percentage of Patients With a 75% Reduction in Psoriasis Area and Severity Index (PASI75) Response at Week 32 |
84.75; 78.99 | — |
| SECONDARY Percentage of Patients With a Static Physician's Global Assessment (sPGA) Score ≤ 1 (Clear or Almost Clear) at Week 32 |
70.34; 64.71 | — |
| SECONDARY Number of Patients With Anti-drug Antibody (ADA) to Adalimumab at Week 32 |
11; 6; 101; 104; 112; 110 | — |
| SECONDARY Number of Patients With Neutralizing Antibody (nAb) to Adalimumab at Week 32 |
66; 64; 46; 46; 112; 110 | — |
| SECONDARY Anti-drug Antibody (ADA) Titer of Patients With ADA at Week 32 |
64.0; 128 | — |
| SECONDARY Neutralizing Anti-drug Antibody (nAb) Titer of Patients With nAb at Week 32 |
2.0; 2.0 | — |
| SECONDARY Percentage of Patients With Drug-related Adverse Events (AEs) During the Post-Randomization Period |
11.9; 18.3 | — |
Eligibility Criteria
Inclusion criteria
- Males and females aged ≥ 18 to 2.5 times upper limit of normal (ULN) at screening.
- Hemoglobin < 8.0 g/dL at screening.
- Platelets < 100,000/μL at screening.
- Leukocyte count < 4000/μL at screening.
- Calculated creatinine clearance < 60 mL/min at screening.
Data sourced from ClinicalTrials.gov (NCT03210259) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.