Clinical trial NCT02850965: Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: Efficacy, Safety, and Immunogenicity 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-08-01
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: The Percentage of Patients With a PASI 75 Response at Week 24
timeFrame: Week 24
measure: The Mean Percentage Improvement in PASI at Week 16
timeFrame: Week 16
measure: The Percentage of Patients With a Static Physician's Global Assessment (sPGA) ≤1 (Clear or Almost Clear) at Week 16
timeFrame: Week 16
measure: The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16
timeFrame: Week 16
measure: The Percentage of Patients With Drug-related Adverse Events (AEs)
timeFrame: From first drug administration until 10 weeks after last drug administration, up to 34 weeks.
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHS Center PC
state: Arizona
city: Santa Ana
country: United States
facility: Southern California Dermatology Inc.
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Chomutov
country: Czechia
facility: Dorothea
city: Olomouc-Povel
country: Czechia
facility: MU Dr. Helena Korandova s.r.o., Olomouc-Povel
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Pardubice
country: Czechia
facility: HOMEA spol. s.r.o., Pardubice
city: Praha
country: Czechia
facility: Univ. Hospital Kralovske Vinohrady
city: Ústí nad Labem
country: Czechia
facility: MU Dr. Jaroslav Dragon, Ústí nad Labem
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research, Tallinn
city: Võru Maakond
country: Estonia
facility: Hospital of South-Estonia Ltd, Võru Maakond
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Darmstadt
country: Germany
facility: Rosenparkklinik GmbH, Darmstadt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Gießen
country: Germany
facility: Gemeinschaftspraxis Dr. Bräu Dr. Gross, Gießen
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Bialystok
country: Poland
facility: NZOZ Specderm, Bialystok
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok
city: Dabrowka
country: Poland
facility: NSZOZ Unica CR, Dabrowka
city: Gdansk
country: Poland
facility: Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne, Poznan
city: Szczecin
country: Poland
facility: Laser Clin. S.C. Dr T. Kochanowski Dr A. Krolicki, Szczecin
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw
city: Kazan
country: Russian Federation
facility: State Medical University, Kazan
city: Saint-Petersburg
country: Russian Federation
facility: Dermatovenereological Dispensary #10, St. Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: ArsVitae NorthWest LLC
city: Saint-Petersburg
country: Russian Federation
facility: 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University, Smolensk
city: St. Petersburg
country: Russian Federation
facility: LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: EKO-Bezopasnost, St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: Institution of Healthcare "Nikolaevskaya Hospital"
city: Banska Bystrica
country: Slovakia
facility: Faculty hospital with clinics F.D. Roosevelta
city: Svidnik
country: Slovakia
facility: Dermatovenerologicke oddelenie sanatorneho typu, Svidnik
city: Kyiv
country: Ukraine
facility: Territorial Medical Association Dermatovenerology, Kyiv
city: Lviv
country: Ukraine
facility: CH of State Border Service of Ukraine, Lviv
city: Odesa
country: Ukraine
facility: CI Odesa Regional Dermatovenerologic Dispensary, Odesa
city: Saint Ivano-Frankivsk
country: Ukraine
facility: CI RC Dermatovenerologic Dispensary, Ivano-Frankivsk
city: Ternopil
country: Ukraine
facility: SI Ternopil Regional Dermatovenerologic Dispensary, Ternopil
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic, Vinnytsia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.