Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT02850965

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2018-01-17

Brief Summary

To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.

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

Humira

Group Type: ACTIVE_COMPARATOR

Humira

Intervention Type: DRUG

Interventions

BI 695501

Intervention Type: DRUG

Humira

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and females aged >=18 to =<80 years 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 study drug (a self-reported diagnosis confirmed by the investigator is acceptable), and which has been stable for the last 2 months with no changes in morphology or significant flares at both Screening and Baseline (Randomization):

• involved body surface area (BSA) >= 10% and
• Psoriasis Area and Severity Index (PASI) score >= 12 and
• static Physician's Global Assessment (sPGA) score of >= 3.
• Participants of reproductive potential (childbearing potential ) must be willing and able to use highly effective methods of birth control per International Council for Harmonization (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.
• 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.

Exclusion Criteria

• Active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment.
• Previous treatment with more than 1 biological agent, or adalimumab or adalimumab biosimilar. No prior biologic exposure within last 6 months of screening.
• 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).
• Major surgery performed within 12 weeks prior to randomization 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 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 study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
• Chronic alcohol or drug abuse
• Women who are pregnant, nursing, or who plan to become pregnant during the course of this study or within the period at least 6 months following completion or discontinuation from the trial.
• 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 tuberculosis; no evidence of active tuberculosis.
• Known clinically significant 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.
• History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients.
• Positive serology for hepatitis B virus (HBV) or hepatitis C virus (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 hospitalization or treatment with intravenous (i.v.) anti infectives within 4 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.
• Creatinine clearance < 60 mL/min/1.73 m2 at Screening.
• Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions.

• 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

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Alliance Dermatology and MOHS Center PC

Phoenix, Arizona, United States

Southern California Dermatology Inc.

Santa Ana, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Advanced Clinical Research

Boise, Idaho, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, United States

Medical Research South

Charleston, South Carolina, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Dorothea

Chomutov, , Czechia

MU Dr. Helena Korandova s.r.o., Olomouc-Povel

Olomouc-Povel, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

HOMEA spol. s.r.o., Pardubice

Pardubice, , Czechia

Univ. Hospital Kralovske Vinohrady

Prague, , Czechia

MU Dr. Jaroslav Dragon, Ústí nad Labem

Ústí nad Labem, , Czechia

Center for Clinical and Basic Research, Tallinn

Tallinn, , Estonia

Hospital of South-Estonia Ltd, Võru Maakond

Võru Maakond, , Estonia

Rothhaar Studien GmbH

Berlin, , Germany

Rosenparkklinik GmbH, Darmstadt

Darmstadt, , Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Gemeinschaftspraxis Dr. Bräu Dr. Gross, Gießen

Giessen, , Germany

TFS Trial Form Support GmbH

Hamburg, , Germany

NZOZ Specderm, Bialystok

Bialystok, , Poland

ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok

Bialystok, , Poland

NSZOZ Unica CR, Dabrowka

Dąbrówka, , Poland

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

Gdansk, , Poland

University Clinical Center, Gdansk

Gdansk, , Poland

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

Gdynia, , Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

Katowice, , Poland

SOLUMED Centrum Medyczne, Poznan

Poznan, , 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

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw

Wroclaw, , Poland

State Medical University, Kazan

Kazan', , Russia

LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

Saint Petersburg, , Russia

Dermatovenereological Dispensary #10, St. Petersburg

Saint Petersburg, , Russia

ArsVitae NorthWest LLC

Saint Petersburg, , Russia

EKO-Bezopasnost, St. Petersburg

Saint Petersburg, , Russia

1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

Saint Petersburg, , Russia

Institution of Healthcare "Nikolaevskaya Hospital"

Saint Petersburg, , Russia

Smolensk State Medical University, Smolensk

Smolensk, , Russia

Faculty hospital with clinics F.D. Roosevelta

Banská Bystrica, , Slovakia

Dermatovenerologicke oddelenie sanatorneho typu, Svidnik

Svidník, , Slovakia

Territorial Medical Association Dermatovenerology, Kyiv

Kyiv, , Ukraine

CH of State Border Service of Ukraine, Lviv

Lviv, , Ukraine

CI Odesa Regional Dermatovenerologic Dispensary, Odesa

Odesa, , Ukraine

CI RC Dermatovenerologic Dispensary, Ivano-Frankivsk

Saint Ivano-Frankivsk, , Ukraine

SI Ternopil Regional Dermatovenerologic Dispensary, Ternopil

Ternopil, , Ukraine

MCIC MC LLC Health Clinic, Vinnytsia

Vinnytsia, , Ukraine

Countries

United States; Czechia; Estonia; Germany; Poland; Russia; Slovakia; Ukraine

References

Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11.

Reference Type: DERIVED

PMID: 40498294 (View on PubMed)

Strand V, McCabe D, Bender S. Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. BMJ Open. 2024 Nov 17;14(11):e081687. doi: 10.1136/bmjopen-2023-081687.

Reference Type: DERIVED

PMID: 39551590 (View on PubMed)

Menter A, Arenberger P, Balser S, Beissert S, Cauthen A, Czeloth N, Soung J, Jazayeri S, Weisenseel P, Jayadeva G. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021 Jan;21(1):87-96. doi: 10.1080/14712598.2021.1851362. Epub 2020 Dec 29.

Reference Type: DERIVED

PMID: 33317345 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-000613-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1297.12

Identifier Type: -

Identifier Source: org_study_id