The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis
- Registration Number
- NCT03210259
- Lead Sponsor
- Boehringer Ingelheim
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 695501 BI 695501 - Humira® Humira® -
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration Time Curve Over the Dosing Interval of Week 30 to 32 (AUCτ, 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. 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.
Maximum Observed Concentration During the Dosing Interval Week 30-32 (Cmax, 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. Maximum observed concentration during the 2 weeks dosing interval between Week 30 to 32 (Cmax, 30-32) for Adalimumab in plasma was reported.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Drug-related Adverse Events (AEs) During the Post-Randomization Period From first dose of trial post-randomization medication until 10 weeks after last dose of trial post-randomization medication, up to 44 weeks Analysis of AEs focused on treatment-emergent adverse events (TEAEs) and is presented here for the post-randomization period (Week 14 to 58). For the post-randomization period analysis, TEAEs were defined as AEs that started or worsened on or after the first dose of trial post-randomization medication and prior to the last dose of trial post-randomization medication + 10 weeks.
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. Minimum Observed Concentration During the 2 weeks Dosing Interval between Week 30 to 32 (Cmin, 30-32) for Adalimumab in plasma was reported.
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. Time to Maximum Observed Concentration During the 2 weeks Dosing Interval between Week 30 to 32 (tmax, 30-32) for Adalimumab in plasma was reported.
Percentage of Patients With a Static Physician's Global Assessment (sPGA) Score ≤ 1 (Clear or Almost Clear) at Week 32 At week 32 The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static", which refers to the patient's disease state at the time of the assessments, without comparison to any of the patient's previous disease states (dynamic), whether at baseline or at a previous visit. A lower score indicates less body coverage and a higher score indicates more severe disease (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe). Results are reported for percentage of patients with a sPGA score of ≤ 1 (clear or almost clear) at Week 32. Analysis was done on per-protocol analysis set (PPS).
Percentage of Patients With a 75% Reduction in Psoriasis Area and Severity Index (PASI75) Response at Week 32 At week 32 The PASI is an established measure of clinical efficacy for psoriasis medications. The PASI is a tool which provides a numeric scoring for patients' overall psoriasis disease state, with scores ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, trunk, upper extremities and lower extremities). Higher PASI scores indicate more severe psoriasis. PASI is generally summarized as a dichotomous outcome based on achieving over an X percent(%) reduction from baseline (or PASIX), where X is 50, 75, 90, and 100. Results are reported for percentage of patients with a PASI75 response at Week 32. Analysis was done on per-protocol analysis set (PPS).
Anti-drug Antibody (ADA) Titer of Patients With ADA at Week 32 Immunogenicity samples were collected pre-dose at Week 32. Anti-drug antibody (ADA) titer of patients with a confirmed positive ADA response to Adalimumab (BI 695501 or Humira) at Week 32.
Neutralizing Anti-drug Antibody (nAb) Titer of Patients With nAb at Week 32 Immunogenicity samples were collected pre-dose at Week 32. Neutralizing anti-drug antibody (nAb) titer of patients with a positive nAb response to Adalimumab (BI 695501 or Humira) 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. Number of patients with a confirmed positive anti-drug antibody (ADA) response to Adalimumab (BI 695501 or Humira) at Week 32. A participant was considered "ADA positive" if the blank normalized signal in the ADA screening assay was equal to or above the study specific ADA screening cut point factor of 1.06 and the signal inhibition by drug in the ADA confirmatory assay was equal to or above the study specific ADA confirmatory cut points (11.4% for signal inhibition with Humira and 12.0% for signal inhibition with BI 695501).
Number of Patients With Neutralizing Antibody (nAb) to Adalimumab at Week 32 Immunogenicity samples were collected pre-dose at Week 32. Number of patients with a positive neutralizing anti-drug antibody (nAb) response to Adalimumab (BI 695501 or Humira) at Week 32. A participant was considered "nAb positive" if the blank normalized signal in the nAb screening assay was equal to or below the study specific nAb screening cut point factor of 0.836.
Trial Locations
- Locations (49)
Universal Clinical Research
🇺🇸Hialeah, Florida, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Arlington Research Center
🇺🇸Arlington, Texas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
J. Kisis Ltd
🇱🇻Riga, Latvia
ALLERGO-DERM BAKOS Kft.
🇭🇺Szolnok, Hungary
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Rothhaar Studien GmbH
🇩🇪Berlin, Germany
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
UNO Medical Trials Kft.
🇭🇺Budapest, Hungary
Klinische Forschung Dresden, GmbH
🇩🇪Dresden, Germany
Szabolcs-Szatmar-Bereg Univ.teach.Hosp
🇭🇺Nyiregyhaza, Hungary
Derma Clinic Riga Ltd
🇱🇻Riga, Latvia
Health Center 4, Affiliate Diagnostic Center
🇱🇻Riga, Latvia
Riga 1st Hosp, Out-patient Department
🇱🇻Riga, Latvia
Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
🇵🇱Gdansk, Poland
Smite Aija practice in dermatology and venerology
🇱🇻Talsi, Latvia
Outpatient Clinic of Ventspils
🇱🇻Ventspils, Latvia
Dermoklinika medical center, Lodz
🇵🇱Lodz, Poland
Malopolskie medical center S.C, Krakow
🇵🇱Krakow, Poland
Treatment - Diagnostic Center PE Asclepius
🇺🇦Uzhgorod, Ukraine
Laser Clin. S.C. Dr T. Kochanowski Dr A. Krolicki, Szczecin
🇵🇱Szczecin, Poland
LLC "Alliance Biomedical - Russian Group"
🇷🇺Saint-Petersburg, Russian Federation
EKO-Bezopasnost, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
Institution of Healthcare "Nikolaevskaya Hospital"
🇷🇺St. Petersburg, Russian Federation
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
CI Zaporizhzhia Regional Dermatovenerologic Clinical Dispensary of Zaporizhzhia RC
🇺🇦Zaporizhzhia, Ukraine
Palmetto Clinical Trial Services, LLC
🇺🇸Fountain Inn, South Carolina, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Shahram Jacobs MD, Inc./Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Poland
Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice
🇵🇱Skierniewice, Poland
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Poradnia Kardiologiczna Jaroslaw Jurowiecki
🇵🇱Gdansk, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
🇵🇱Gdynia, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa
🇵🇱Warszawa, Poland
University of South Florida
🇺🇸Tampa, Florida, United States