Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02871635
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: BI 695501 Drug: HUMIRA Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: BI 695501 Drug: BI 695501
Active Comparator: HUMIRA + BI 695501 Drug: BI 695501
Drug: HUMIRA



Primary Outcome Measures :
  1. Proportion of patients in each treatment group with a clinical response (Crohn's Disease Activity Index decrease of >=70 compared with baseline) at Week 4 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients who experience hypersensitivity reactions [ Time Frame: 56 weeks ]
  2. Proportion of patients with injection-site reactions [ Time Frame: 56 weeks ]
  3. Proportion of patients in each treatment group with a clinical response (Crohn's Disease Activity Index decrease of >=70 compared with baseline) at Week 24 [ Time Frame: 24 weeks ]
  4. Proportion of patients in each treatment group in clinical remission (Crohn's Disease Activity Index <150) at Week 24 [ Time Frame: 24 weeks ]
  5. Proportion of patients with adverse events, serious adverse events, and adverse events of special interests [ Time Frame: 56 weeks ]
  6. Proportion of patients with infections/serious infections (seriousness of infection defined as requirement of intravenous antibiotics for treatment and/or meeting seriousness criteria to be qualified as an serious adverse event) [ Time Frame: 56 weeks ]
  7. Proportion of patients who experience Drug Induced Liver Injury [ Time Frame: 56 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871635


  Hide Study Locations
Locations
Layout table for location information
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Hope Clinical Research
Kissimmee, Florida, United States, 34741
Center for Advanced GI
Maitland, Florida, United States, 32751
Advance Medical Research Center
Miami, Florida, United States, 33155
Advanced Research Institute, Inc
New Port Richey, Florida, United States, 34653
United States, Georgia
Doctors Clinical Research
East Point, Georgia, United States, 30344
United States, Illinois
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7702
United States, Maryland
MGG Grp ChevyChase ClinicRsrch
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland
Columbia, Maryland, United States, 21045
United States, Missouri
Healthcare Research Network
Hazelwood, Missouri, United States, 63042
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
United States, Ohio
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
United States, South Carolina
Gastroenterology Associates, PA
Greenville, South Carolina, United States, 29615
United States, Texas
Houston Endoscopy and Research Center
Houston, Texas, United States, 77079
Biopharma Informatic, Inc, dba Research Consultants
Katy, Texas, United States, 77450
Sagact, Pllc
San Antonio, Texas, United States, 78229
Baylor Scott and White Healthcare
Temple, Texas, United States, 76508
Victoria Gastroenterology
Victoria, Texas, United States, 77904
Belarus
Gomel Regional Clinical
Gomel, Belarus, 246012
City Clinical Hospital # 10
Minsk, Belarus, 220096
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, Belarus, 210603
Bosnia and Herzegovina
University Clinical Centre Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Croatia
Clinical Hospital Osijek
Osijek, Croatia, 31000
Polyclinic Bonifarm
Zagreb, Croatia, 10000
Czechia
Vojenska nemocnice Brno
Brno, Czechia, 63600
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 50012
CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
Olomouc, Czechia, 779 00
Gregar s.r.o.
Olomouc, Czechia, 779 00
PreventaMed, s.r.o.
Olomouc, Czechia, 77900
University Hospital Ostrava
Ostrava-Poruba, Czechia, 708 52
Vitkovice Hospital
Ostrava-Vitkovice, Czechia, 703 84
Medicon, a.s.
Prague, Czechia, 140 00
University Hospital Na Bulovce
Praha 8, Czechia, 27711
Axon Clinical, s.r.o.
Praha, Czechia, 15000
General Hospital Pribram
Pribram, Czechia, 261 01
Masaryk Hospital, Internal Department
Usti nad Labem, Czechia, 401 13
Germany
Crohn Colitis Centrum Rhein Main
Frankfurt, Germany, 60594
Greece
General Hospital of Athens Evangelismos
Athens, Greece, 10676
University General Hospital of Heraklion
Heraklion, Crete, Greece, 71110
General Hospital of Rhodes
Rhodes, Greece, 85100
Israel
Haemek Medical Center
Afula, Israel, 18101
Wolfson Medical Center
Holon, Israel, 58100
Hadassah Medical Center, Ein-Karem
Jerusalem, Israel, 9112001
Meir Medical Center
Kfar-Saba, Israel, 4428164
The Chaim Sheba Medical Center Tel Hashomer
Ramat Gan, Israel, 52621
Kaplan Medical Center
Rehovot, Israel, 76100
Poland
KLIMED Marek Klimkiewicz
Bialystok, Poland, 15-765
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland, 85231
Medical Center Pleiades
Cracow, Poland, 30-363
Polimedica Centrum Badan
Kielce, Poland, 25634
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurow, Poland, 44190
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
Lodz, Poland, 90-302
Clinic Medical Center; Nowa Sol
Nowa Sol, Poland, 67-100
Ai Medical Center, private practice, Poznan
Poznan, Poland, 61-113
Gabinet Lekarski Bartosz Korczowski
Rzeszow, Poland, 35302
Specialized Medical Practice. Dr med. Marek Horynski
Sopot, Poland, 81756
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, Poland, 71270
Russian Federation
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, Russian Federation, 656043
GUZ Reg. Clinical Hospital, Kemerovo
Kemerovo, Russian Federation, 650066
Clinical Hospital No. 24, Moscow
Moscow, Russian Federation, 127015
Murmansk Regional Clinical Hospital named after Bayandin
Murmansk, Russian Federation, 183047
Reg.Clin.Hosp.n.a.Semashko
Nizhniy Novgorod, Russian Federation, 603126
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation, 630091
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
Novosibirsk, Russian Federation, 630117
BHI of Omsk region - Clinical Oncology Dispensary
Omsk, Russian Federation, 644013
SBIH City Clinical Hospital #31
Saint Petersburg, Russian Federation, 194291
LLC IClinic
Saint Petersburg, Russian Federation, 197110
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, Russian Federation, 443001
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
Samara, Russian Federation, 443041
Baltic Med,LLC Clinic BaltMed Ozerki
St. Petersburg, Russian Federation, 194356
EKO-Bezopasnost, St. Petersburg
St. Petersburg, Russian Federation, 196143
Serbia
Clinical Medical Center Zvezdara, Belgrade
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinical Center Zemun
Belgrade, Serbia, 11080
Clinical Hospital Center "Bezanijska Kosa"
Belgrade, Serbia, 11080
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Turkey
Gazi University Medical Faculty
Ankara, Turkey, 06500
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, Turkey, 27310
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, Turkey, 34890
Kocaeli University Research and Training Hospital
Kocaeli, Turkey, 41380
Ukraine
CI Cherkasy RH of Cherkasy Reg.Council
Cherkasy, Ukraine, 18009
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, Ukraine, 61037
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kiev, Ukraine, 02091
Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
Kirovohrad, Ukraine, 25006
Medical Center Medical Clinic Kyiv
Kyiv, Ukraine, 01601
Clin Hosp.8 P.L.Shupyk NMA of PGE
Kyiv, Ukraine, 04201
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
Vinnytsia, Ukraine, 21005
M.I. Pyrogov VRCH, Vinnytsia
Vinnytsia, Ukraine, 21018
Clin.Hosp#1,Zaporizhzhia
Zaporizhzhia, Ukraine, 69104
United Kingdom
Royal Bournemouth and Christchurch Hospital
Bournemouth, United Kingdom, BH7 7DW
Walsall Manor Hospital
Walsall, United Kingdom, WS2 9PS
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02871635     History of Changes
Other Study ID Numbers: 1297.4
2016-000612-14 ( EudraCT Number )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents