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Completed Phase 3 Interventional Results available

The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis

ClinicalTrials.gov ID: NCT03210259

Public ClinicalTrials.gov record NCT03210259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 11:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03210259
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
259 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 10, 2017 (Actual)
Primary completion
Apr 16, 2019 (Actual)
Completion
Apr 16, 2019 (Actual)
Last update posted
Jul 14, 2021

2017 – 2019

United States locations

U.S. sites
21
U.S. states
11
U.S. cities
20
Facility City State ZIP Site status
Total Skin and Beauty Dermatology Center, PC Birmingham Alabama 35205 —
University of Alabama at Birmingham Birmingham Alabama 35233 —
California Dermatology & Clinical Research Institute Encinitas California 92024 —
Dermatology Research Associates Los Angeles California 90045 —
Shahram Jacobs MD, Inc./Unison Clinical Trials Sherman Oaks California 91403 —
Universal Clinical Research Hialeah Florida 33012 —
New Horizon Research Center Miami Florida 33175 —
Renstar Medical Research Ocala Florida 34471 —
Progressive Medical Research Port Orange Florida 32127 —
University of South Florida Tampa Florida 33612 —
Palm Beach Research Center West Palm Beach Florida 33409 —
Kansas City Dermatology, PA Overland Park Kansas 66215 —
Great Lakes Research Group, Inc. Bay City Michigan 48706 —
MediSearch Clinical Trials Saint Joseph Missouri 64506 —
Dermatology Consulting Services High Point North Carolina 27262 —
Clinical Partners, LLC Johnston Rhode Island 02919 —
Palmetto Clinical Trial Services, LLC Fountain Inn South Carolina 29681 —
Arlington Research Center Arlington Texas 76011 —
Center for Clinical Studies Houston Texas 77004 —
Clinical Trials of Texas, Inc. San Antonio Texas 78229 —
MultiCare Institute for Research and Innovation Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03210259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03210259 live on ClinicalTrials.gov.

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