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

NCT02871635 | Completed Phase 3 Results

• 2 other identifiers: 1297.42016-000612-14
• Study Type: interventional
• Target: 147
• Locations: 14 countries
• Sites: 92

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4

  The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).

  Week 4

Secondary Outcomes (8)

• Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24

  Week 24

• Percentage of Patients in Clinical Remission (CDAI <150) at Week 24

  at Week 24

• Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)

  From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

• Percentage of Patients With Infections

  From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

• Percentage of Patients With Serious Infections

  From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

Study Arms (2)

BI 695501

EXPERIMENTAL

Drug: BI 695501

HUMIRA + BI 695501

ACTIVE COMPARATOR

Drug: BI 695501; Drug: HUMIRA

Interventions

BI 695501 DRUG

BI 695501; HUMIRA + BI 695501

HUMIRA DRUG

HUMIRA + BI 695501

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (92)

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Hope Clinical Research

Kissimmee, Florida, 34741, United States

Location

Center for Advanced GI

Maitland, Florida, 32751, United States

Location

Advance Medical Research Center

Miami, Florida, 33155, United States

Location

Advanced Research Institute, Inc

New Port Richey, Florida, 34653, United States

Location

Doctors Clinical Research

East Point, Georgia, 30344, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7702, United States

Location

MGG Group Co. Inc. / Chevy Chase Clinical Research,

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Gastroenterology Associates, PA

Greenville, South Carolina, 29615, United States

Location

Houston Endoscopy and Research Center

Houston, Texas, 77079, United States

Location

Biopharma Informatic, Inc, dba Research Consultants

Katy, Texas, 77450, United States

Location

Sagact, Pllc

San Antonio, Texas, 78229, United States

Location

Baylor Scott and White Healthcare

Temple, Texas, 76508, United States

Location

Victoria Gastroenterology

Victoria, Texas, 77904, United States

Location

Gomel Regional Clinical

Homyel, 246012, Belarus

Location

City Clinical Hospital # 10

Minsk, 220096, Belarus

Location

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, 210603, Belarus

Location

University Clinical Centre Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Clinical Hospital Osijek

Osijek, 31000, Croatia

Location

Polyclinic Bonifarm

Zagreb, 10000, Croatia

Location

Vojenska nemocnice Brno

Brno, 63600, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 50012, Czechia

Location

CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc

Olomouc, 779 00, Czechia

Location

Gregar s.r.o.

Olomouc, 779 00, Czechia

Location

PreventaMed, s.r.o.

Olomouc, 77900, Czechia

Location

University Hospital Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Vitkovice Hospital

Ostrava-Vitkovice, 703 84, Czechia

Location

Medicon, a.s.

Prague, 140 00, Czechia

Location

Axon Clinical, s.r.o.

Prague, 15000, Czechia

Location

University Hospital Na Bulovce

Prague, 27711, Czechia

Location

General Hospital Pribram

Příbram, 261 01, Czechia

Location

Masaryk Hospital, Internal Department

Ústí nad Labem, 401 13, Czechia

Location

Crohn Colitis Centrum Rhein Main

Frankfurt, 60594, Germany

Location

General Hospital of Athens Evangelismos

Athens, 10676, Greece

Location

University General Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

General Hospital of Rhodes

Rhodes, 85100, Greece

Location

Haemek Medical Center

Afula, 18101, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Hadassah Medical Center, Ein-Karem

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

The Chaim Sheba Medical Center Tel Hashomer

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

KLIMED Marek Klimkiewicz

Bialystok, 15-765, Poland

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85231, Poland

Location

Polimedica Centrum Badan

Kielce, 25634, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, 44190, Poland

Location

Medical Center Pleiades

Krakow, 30-363, Poland

Location

SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

Lodz, 90-302, Poland

Location

Clinic Medical Center; Nowa Sol

Nowa Sól, 67-100, Poland

Location

Ai Medical Center, private practice, Poznan

Poznan, 61-113, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, 35302, Poland

Location

Specialized Medical Practice. Dr med. Marek Horynski

Sopot, 81756, Poland

Location

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71270, Poland

Location

Multidisciplinary Medical Clinic "Anthurium"

Barnaul, 656043, Russia

Location

GUZ Reg. Clinical Hospital, Kemerovo

Kemerovo, 650066, Russia

Location

Clinical Hospital No. 24, Moscow

Moscow, 127015, Russia

Location

Murmansk Regional Clinical Hospital named after Bayandin

Murmansk, 183047, Russia

Location

Reg.Clin.Hosp.n.a.Semashko

Nizhny Novgorod, 603126, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630091, Russia

Location

FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"

Novosibirsk, 630117, Russia

Location

BHI of Omsk region - Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

SBIH City Clinical Hospital #31

Saint Petersburg, 194291, Russia

Location

Baltic Med,LLC Clinic BaltMed Ozerki

Saint Petersburg, 194356, Russia

Location

EKO-Bezopasnost, St. Petersburg

Saint Petersburg, 196143, Russia

Location

LLC IClinic

Saint Petersburg, 197110, Russia

Location

Private Educational Institution of Higher Education "Medical University "REAVIZ"

Samara, 443001, Russia

Location

NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"

Samara, 443041, Russia

Location

Clinical Medical Center Zvezdara, Belgrade

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska kosa, Belgrade

Belgrade, 11080, Serbia

Location

Clinical Center Zemun

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

Kartal Lutfi Kirdar Research and Training Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Kocaeli University Research and Training Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

CI Cherkasy RH of Cherkasy Reg.Council

Cherkasy, 18009, Ukraine

Location

CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

Kharkiv, 61037, Ukraine

Location

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

Kiev, 02091, Ukraine

Location

Private Enterprise Private Manufacturing Company "Acinus"

Kirovohrad, 25006, Ukraine

Location

Medical Center Medical Clinic Kyiv

Kyiv, 01601, Ukraine

Location

Clin Hosp.8 P.L.Shupyk NMA of PGE

Kyiv, 04201, Ukraine

Location

Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3

Vinnytsia, 21005, Ukraine

Location

M.I. Pyrogov VRCH, Vinnytsia

Vinnytsia, 21018, Ukraine

Location

Clin.Hosp#1,Zaporizhzhia

Zaporizhzhia, 69104, Ukraine

Location

Royal Bournemouth and Christchurch Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Walsall Manor Hospital

Walsall, WS2 9PS, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 40498294 DERIVED

• 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.

  PMID: 39551590 DERIVED

• Hanauer S. Plain language summary of the VOLTAIRE-CD study in people with moderate-to-severe active Crohn's disease. Immunotherapy. 2022 Dec;14(17):1353-1359. doi: 10.2217/imt-2022-0129. Epub 2022 Dec 13.

  PMID: 36511191 DERIVED

• 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.

  PMID: 34388360 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

BI 695501; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: September 28, 2016
• Primary Completion: April 30, 2019
• Study Completion: May 13, 2019
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Locations

UA (9); CR (2); GR (3); BO (1); GB (2); IL (6); PL (11); DE (1); US (19); CZ (12); BE (3); RU (14); SE (5); TU (4)