Clinical trial NCT02871635: BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Official title: BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 147
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: Primary Objective:

The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.


Eligibility criteria: Inclusion criteria:

* Males and females aged \>=18 and =\<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:

  * Crohn's Disease Activity Index (CDAI) score of \>=220 and =\<450
  * A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening
  * Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization
* Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:

  * Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion
  * Responded and became intolerant
* Further inclusion criteria apply

Exclusion criteria:

* Patients with ulcerative colitis or indeterminate colitis
* Patients with symptomatic known obstructive strictures
* Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial
* Patients with an ostomy or ileoanal pouch
* Patients with short bowel syndrome
* Patients who have previously used infliximab and have never clinically responded
* Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial
* Further exclusion criteria apply

Primary outcomes:
measure: Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
timeFrame: Week 24
measure: Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
timeFrame: at Week 24
measure: Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
measure: Percentage of Patients With Infections
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
measure: Percentage of Patients With Serious Infections
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
measure: Percentage of Patients Who Experienced Hypersensitivity Reactions
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
measure: Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
measure: Percentage of Patients With Injection Site Reactions
timeFrame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Kissimmee
country: United States
facility: Hope Clinical Research
state: Florida
city: Maitland
country: United States
facility: Center for Advanced GI
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc
state: Florida
city: East Point
country: United States
facility: Doctors Clinical Research
state: Georgia
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Chevy Chase
country: United States
facility: MGG Group Co. Inc. / Chevy Chase Clinical Research,
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: Katy
country: United States
facility: Biopharma Informatic, Inc, dba Research Consultants
state: Texas
city: San Antonio
country: United States
facility: Sagact, Pllc
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Healthcare
state: Texas
city: Victoria
country: United States
facility: Victoria Gastroenterology
state: Texas
city: Gomel
country: Belarus
facility: Gomel Regional Clinical
city: Minsk
country: Belarus
facility: City Clinical Hospital # 10
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Dispensary
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Centre Sarajevo
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek
city: Zagreb
country: Croatia
facility: Polyclinic Bonifarm
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Olomouc
country: Czechia
facility: CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
city: Olomouc
country: Czechia
facility: Gregar s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
city: Ostrava-Vitkovice
country: Czechia
facility: Vitkovice Hospital
city: Prague
country: Czechia
facility: Medicon, a.s.
city: Praha 8
country: Czechia
facility: University Hospital Na Bulovce
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o.
city: Pribram
country: Czechia
facility: General Hospital Pribram
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital, Internal Department
city: Frankfurt
country: Germany
facility: Crohn Colitis Centrum Rhein Main
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos
city: Heraklion, Crete
country: Greece
facility: University General Hospital of Heraklion
city: Rhodes
country: Greece
facility: General Hospital of Rhodes
city: Afula
country: Israel
facility: Haemek Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center Tel Hashomer
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
city: Cracow
country: Poland
facility: Medical Center Pleiades
city: Kielce
country: Poland
facility: Polimedica Centrum Badan
city: Knurow
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Lodz
country: Poland
facility: SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
city: Nowa Sol
country: Poland
facility: Clinic Medical Center; Nowa Sol
city: Poznan
country: Poland
facility: Ai Medical Center, private practice, Poznan
city: Rzeszow
country: Poland
facility: Gabinet Lekarski Bartosz Korczowski
city: Sopot
country: Poland
facility: Specialized Medical Practice. Dr med. Marek Horynski
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Barnaul
country: Russian Federation
facility: Multidisciplinary Medical Clinic "Anthurium"
city: Kemerovo
country: Russian Federation
facility: GUZ Reg. Clinical Hospital, Kemerovo
city: Moscow
country: Russian Federation
facility: Clinical Hospital No. 24, Moscow
city: Murmansk
country: Russian Federation
facility: Murmansk Regional Clinical Hospital named after Bayandin
city: Nizhniy Novgorod
country: Russian Federation
facility: Reg.Clin.Hosp.n.a.Semashko
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region - Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
city: Saint Petersburg
country: Russian Federation
facility: LLC IClinic
city: Samara
country: Russian Federation
facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"
city: Samara
country: Russian Federation
facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
city: St. Petersburg
country: Russian Federation
facility: Baltic Med,LLC Clinic BaltMed Ozerki
city: St. Petersburg
country: Russian Federation
facility: EKO-Bezopasnost, St. Petersburg
city: Belgrade
country: Serbia
facility: Clinical Medical Center Zvezdara, Belgrade
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska kosa, Belgrade
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
city: Istanbul
country: Turkey
facility: Kartal Lutfi Kirdar Research and Training Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Training Hospital
city: Cherkasy
country: Ukraine
facility: CI Cherkasy RH of Cherkasy Reg.Council
city: Kharkiv
country: Ukraine
facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
city: Kiev
country: Ukraine
facility: Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
city: Kirovohrad
country: Ukraine
facility: Private Enterprise Private Manufacturing Company "Acinus"
city: Kyiv
country: Ukraine
facility: Medical Center Medical Clinic Kyiv
city: Kyiv
country: Ukraine
facility: Clin Hosp.8 P.L.Shupyk NMA of PGE
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH, Vinnytsia
city: Zaporizhzhia
country: Ukraine
facility: Clin.Hosp#1,Zaporizhzhia
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospital
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Hanauer S, Liedert B, Balser S, Brockstedt E, Moschetti V, Schreiber S. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):816-825. doi: 10.1016/S2468-1253(21)00252-1. Epub 2021 Aug 11.