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

NCT03210259 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 1297-00092016-002254-20
• Study Type: interventional
• Target: 259
• Locations: 7 countries
• Sites: 49

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration Time Curve Over the Dosing Interval of Week 30 to 32 (AUCτ, 30-32) for Adalimumab in Plasma

  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.

  Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.

• Maximum Observed Concentration During the Dosing Interval Week 30-32 (Cmax, 30-32) for Adalimumab in Plasma

  Maximum observed concentration during the 2 weeks dosing interval between Week 30 to 32 (Cmax, 30-32) for Adalimumab in plasma was reported.

  Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.

Secondary Outcomes (9)

• Minimum Observed Concentration During the Dosing Interval of Week 30 to 32 (Cmin, 30-32) for Adalimumab in Plasma

  Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.

• Time to Maximum Observed Concentration During the Dosing Interval of Week 30 to 32 (Tmax, 30-32) for Adalimumab in Plasma

  Pre-dose at Week 30, at 72, 120, 168 and 240 hours after the Week 30 dosing, and pre-dose at Week 32.

• Percentage of Patients With a 75% Reduction in Psoriasis Area and Severity Index (PASI75) Response at Week 32

  At week 32

• Percentage of Patients With a Static Physician's Global Assessment (sPGA) Score ≤ 1 (Clear or Almost Clear) at Week 32

  At week 32

• Number of Patients With Anti-drug Antibody (ADA) to Adalimumab at Week 32

  Immunogenicity samples were collected pre-dose at Week 32.

Study Arms (2)

BI 695501

EXPERIMENTAL

Drug: BI 695501

Humira®

ACTIVE COMPARATOR

Drug: Humira®

Interventions

Humira® DRUG

Duration - 58 weeks

Humira®

BI 695501 DRUG

Duration - 58 weeks

Also known as: CYLTEZO

BI 695501

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (49)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Shahram Jacobs MD, Inc./Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Universal Clinical Research

Hialeah, Florida, 33012, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Kansas City Dermatology, PA

Overland Park, Kansas, 66215, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, 29681, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

Klinische Forschung Dresden, GmbH

Dresden, 01069, Germany

Location

UNO Medical Trials Kft.

Budapest, 1135, Hungary

Location

Szabolcs-Szatmar-Bereg Univ.teach.Hosp

Nyíregyháza, 4400, Hungary

Location

ALLERGO-DERM BAKOS Kft.

Szolnok, 5000, Hungary

Location

Riga 1st Hosp, Out-patient Department

Riga, 1001, Latvia

Location

Derma Clinic Riga Ltd

Riga, LV-1003, Latvia

Location

Health Center 4, Affiliate Diagnostic Center

Riga, LV-1003, Latvia

Location

J. Kisis Ltd

Riga, LV-1003, Latvia

Location

Smite Aija practice in dermatology and venerology

Talsi, LV-3201, Latvia

Location

Outpatient Clinic of Ventspils

Ventspils, LV-3601, Latvia

Location

Poradnia Kardiologiczna Jaroslaw Jurowiecki

Gdansk, 80-286, Poland

Location

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

Gdansk, 80-382, Poland

Location

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

Gdynia, 81-384, Poland

Location

Malopolskie medical center S.C, Krakow

Krakow, 31-510, Poland

Location

SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

Lodz, 90-302, Poland

Location

Dermoklinika medical center, Lodz

Lodz, 90-436, Poland

Location

Medicome Sp. z o.o.

Oświęcim, 32-600, Poland

Location

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

Skierniewice, 96-100, Poland

Location

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

Szczecin, 70-332, Poland

Location

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

Warsaw, 01-192, Poland

Location

LLC "Alliance Biomedical - Russian Group"

Saint Petersburg, 194356, Russia

Location

EKO-Bezopasnost, St. Petersburg

Saint Petersburg, 196143, Russia

Location

Institution of Healthcare "Nikolaevskaya Hospital"

Saint Petersburg, 198510, Russia

Location

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

Dnipro, 49008, Ukraine

Location

Kherson clin.hosp.Afanasiia&Olhy Tropinykh

Kherson, 73000, Ukraine

Location

Treatment - Diagnostic Center PE Asclepius

Uzhhorod, 88000, Ukraine

Location

CI Zaporizhzhia Regional Dermatovenerologic Clinical Dispensary of Zaporizhzhia RC

Zaporizhzhia, 69063, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 35934770 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; BI 695501

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 6, 2017
• Study Start: July 10, 2017
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: July 14, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-07

Locations

LA (6); RU (3); HU (3); US (21); DE (2); PL (10); UA (4)