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

NCT ID: NCT03210259

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2019-04-16

Brief 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®.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 695501

Group Type: EXPERIMENTAL

BI 695501

Intervention Type: DRUG

Duration - 58 weeks

Humira®

Group Type: ACTIVE_COMPARATOR

Humira®

Intervention Type: DRUG

Duration - 58 weeks

Interventions

Humira®

Duration - 58 weeks

Intervention Type: DRUG

BI 695501

Duration - 58 weeks

Intervention Type: DRUG

Other Intervention Names

CYLTEZO

Eligibility Criteria

Inclusion Criteria

• Males and females aged ≥ 18 to < 80 years at screening who have a diagnosis of moderate-to-severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of trial drug (a self-reported diagnosis confirmed by the Investigator is acceptable), and which has been stable per Investigator opinion for the last 2 months with no changes in morphology or significant flares at both screening and baseline:

• involved body surface area (BSA) ≥ 10% and
• PASI score ≥ 12 and
• sPGA score of ≥ 3.
• Participants of reproductive potential (childbearing potential1) must be willing and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during the trial and for 6 months following completion or discontinuation from the trial medication. A list of contraception methods meeting these criteria is provided in patient information.
• Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
• Patients who are candidates for systemic therapy or phototherapy according to Investigator judgement.

Exclusion Criteria

• Active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to Investigator's judgment.
• Prior exposure to any biologic therapies for any auto-immune diseases (eg: RA, Psoriasis, Crohns Disease, etc).
• Patients with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders). A significant disease is defined as a disease which, in the opinion of the Investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
• Major surgery (major according to the Investigator's assessment) performed within 12 weeks before enrollment or planned within 6 months after screening, e.g., total hip replacement.
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated (in the opinion of the Investigator) basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
• Currently enrolled in another investigational device or drug trial, or less than 30 days (or less than 5 half-lives, whichever is longer) since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
• Chronic alcohol or drug abuse or any condition that, in the Investigator's opinion, makes the patient an unreliable trial subject or unlikely to complete the trial.
• Women who are pregnant, nursing, or who plan to become pregnant during the course of this trial or within the period at least 6 months following completion or discontinuation from the trial medication.
• Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g., beta blockers or lithium).
• Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection or a positive HIV test at screening (per the Investigator discretion and where mandated by local authorities).
• Known chronic or relevant acute TB; IGRA TB test or PPD skin test will be performed according to the labelling for Humira®. If the result is positive, patients may participate in the trial if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If latent TB is confirmed, then treatment must have been initiated before treatment in the study and continued according to local country guidelines.
• Known clinically significant (per Investigator opinion) coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure (New York Heart Association Classes III or IV) or interstitial lung disease observed on chest X-ray.
• Patients with a history of any clinically significant adverse reaction (including serious allergic reactions, or anaphylactic reaction, or hypersensitivity) to murine or chimeric proteins, previously used biological drug or its excipients, or natural rubber and latex.
• Positive serology for HBV or HCV.
• Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit; patients who are expecting to receive any live/attenuated virus or bacterial vaccinations during the trial or up to 3 months after the last dose of trial drug.
• Any treatment (including biologic therapies) that, in the opinion of the Investigator, may place the patient at unacceptable risk during the trial.
• Known active infection of any kind (excluding fungal infections of nail beds), any major episode of infection requiring hospitalisation or treatment with intravenous (i.v.) antiinfectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Shahram Jacobs MD, Inc./Unison Clinical Trials

Sherman Oaks, California, United States

Universal Clinical Research

Hialeah, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

University of South Florida

Tampa, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Kansas City Dermatology, PA

Overland Park, Kansas, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, United States

Arlington Research Center

Arlington, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

Rothhaar Studien GmbH

Berlin, , Germany

Klinische Forschung Dresden, GmbH

Dresden, , Germany

UNO Medical Trials Kft.

Budapest, , Hungary

Szabolcs-Szatmar-Bereg Univ.teach.Hosp

Nyíregyháza, , Hungary

ALLERGO-DERM BAKOS Kft.

Szolnok, , Hungary

Riga 1st Hosp, Out-patient Department

Riga, , Latvia

Derma Clinic Riga Ltd

Riga, , Latvia

Health Center 4, Affiliate Diagnostic Center

Riga, , Latvia

J. Kisis Ltd

Riga, , Latvia

Smite Aija practice in dermatology and venerology

Talsi, , Latvia

Outpatient Clinic of Ventspils

Ventspils, , Latvia

Poradnia Kardiologiczna Jaroslaw Jurowiecki

Gdansk, , Poland

Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

Gdansk, , Poland

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

Gdynia, , Poland

Malopolskie medical center S.C, Krakow

Krakow, , Poland

SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

Dermoklinika medical center, Lodz

Lodz, , Poland

Medicome Sp. z o.o.

Oświęcim, , Poland

Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice

Skierniewice, , Poland

Laser Clin. S.C. Dr T. Kochanowski Dr A. Krolicki, Szczecin

Szczecin, , Poland

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa

Warsaw, , Poland

LLC "Alliance Biomedical - Russian Group"

Saint Petersburg, , Russia

EKO-Bezopasnost, St. Petersburg

Saint Petersburg, , Russia

Institution of Healthcare "Nikolaevskaya Hospital"

Saint Petersburg, , Russia

SI Road Clinical Hospital of DS of SE PZ Dept of Dermatovenerology SI DMA of MOHU

Dnipro, , Ukraine

Kherson clin.hosp.Afanasiia&Olhy Tropinykh

Kherson, , Ukraine

Treatment - Diagnostic Center PE Asclepius

Uzhhorod, , Ukraine

CI Zaporizhzhia Regional Dermatovenerologic Clinical Dispensary of Zaporizhzhia RC

Zaporizhzhia, , Ukraine

Countries

United States; Germany; Hungary; Latvia; Poland; Russia; Ukraine

References

Menter A, Cohen S, Kay J, Strand V, Gottlieb A, Hanauer S, Eduru SK, Buschke S, Lang B, Liesenfeld KH, Schaible J, McCabe D. Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. Am J Clin Dermatol. 2022 Sep;23(5):719-728. doi: 10.1007/s40257-022-00708-w. Epub 2022 Aug 7.

Reference Type: DERIVED

PMID: 35934770 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002254-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1297-0009

Identifier Type: -

Identifier Source: org_study_id