Crohn DiseasePhase 3NCT02871635
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
A Phase 3 study testing BI 695501 and HUMIRA in people with Crohn Disease, run by Boehringer Ingelheim at 92 sites in 14 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- BI 695501 and HUMIRA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 92 sitesin 14 countries
- Study dates
- 28 Sep 2016to 13 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
92 sites in 14 countries.
92 sites in 14 countries
United States19 sites
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
MGG Group Co. Inc. / Chevy Chase Clinical Research,
Chevy Chase, Maryland, 20815
Gastro Center of Maryland
Columbia, Maryland, 21045
Doctors Clinical Research
East Point, Georgia, 30344
Gastroenterology Associates, PA
Greenville, South Carolina, 29615
Healthcare Research Network
Hazelwood, Missouri, 63042
Houston Endoscopy and Research Center
Houston, Texas, 77079
Borland-Groover Clinic
Jacksonville, Florida, 32256
University of Kansas Medical Center
Kansas City, Kansas, 66160-7702
Biopharma Informatic, Inc, dba Research Consultants
Katy, Texas, 77450
Hope Clinical Research
Kissimmee, Florida, 34741
Center for Advanced GI
Maitland, Florida, 32751
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Advance Medical Research Center
Miami, Florida, 33155
Advanced Research Institute, Inc
New Port Richey, Florida, 34653
Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Sagact, Pllc
San Antonio, Texas, 78229
Baylor Scott and White Healthcare
Temple, Texas, 76508
Victoria Gastroenterology
Victoria, Texas, 77904
Russia14 sites
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043
GUZ Reg. Clinical Hospital, Kemerovo
Kemerovo, 650066
Clinical Hospital No. 24, Moscow
Moscow, 127015
Murmansk Regional Clinical Hospital named after Bayandin
Murmansk, 183047
Reg.Clin.Hosp.n.a.Semashko
Nizhny Novgorod, 603126
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630091
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
Novosibirsk, 630117
BHI of Omsk region - Clinical Oncology Dispensary
Omsk, 644013
SBIH City Clinical Hospital #31
Saint Petersburg, 194291
Baltic Med,LLC Clinic BaltMed Ozerki
Saint Petersburg, 194356
EKO-Bezopasnost, St. Petersburg
Saint Petersburg, 196143
LLC IClinic
Saint Petersburg, 197110
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, 443001
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
Samara, 443041
Czechia12 sites
Vojenska nemocnice Brno
Brno, 63600
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012
CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
Olomouc, 779 00
Gregar s.r.o.
Olomouc, 779 00
PreventaMed, s.r.o.
Olomouc, 77900
University Hospital Ostrava
Ostrava-Poruba, 708 52
Vitkovice Hospital
Ostrava-Vitkovice, 703 84
Medicon, a.s.
Prague, 140 00
Axon Clinical, s.r.o.
Prague, 15000
University Hospital Na Bulovce
Prague, 27711
General Hospital Pribram
Příbram, 261 01
Masaryk Hospital, Internal Department
Ústí nad Labem, 401 13
Poland11 sites
KLIMED Marek Klimkiewicz
Bialystok, 15-765
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85231
Medical Center Pleiades
Cracow, 30-363
Polimedica Centrum Badan
Kielce, 25634
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44190
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302
Clinic Medical Center; Nowa Sol
Nowa Sól, 67-100
Ai Medical Center, private practice, Poznan
Poznan, 61-113
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35302
Specialized Medical Practice. Dr med. Marek Horynski
Sopot, 81756
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71270
Ukraine9 sites
CI Cherkasy RH of Cherkasy Reg.Council
Cherkasy, 18009
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, 61037
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kiev, 02091
Private Enterprise Private Manufacturing Company "Acinus"
Kirovohrad, 25006
Medical Center Medical Clinic Kyiv
Kyiv, 01601
Clin Hosp.8 P.L.Shupyk NMA of PGE
Kyiv, 04201
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
Vinnytsia, 21005
M.I. Pyrogov VRCH, Vinnytsia
Vinnytsia, 21018
Clin.Hosp#1,Zaporizhzhia
Zaporizhzhya, 69104
Israel6 sites
Haemek Medical Center
Afula, 18101
Wolfson Medical Center
Holon, 58100
Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
The Chaim Sheba Medical Center Tel Hashomer
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Serbia5 sites
Clinical Medical Center Zvezdara, Belgrade
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Center Bezanijska kosa, Belgrade
Belgrade, 11080
Clinical Center Zemun
Belgrade, 11080
Clinical Center Kragujevac
Kragujevac, 34000
Turkey (Türkiye)4 sites
Gazi University Medical Faculty
Ankara, 06500
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, 27310
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, 34890
Kocaeli University Research and Training Hospital
Kocaeli, 41380
Belarus3 sites
Gomel Regional Clinical
Homyel, 246012
City Clinical Hospital # 10
Minsk, 220096
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603
Greece3 sites
General Hospital of Athens Evangelismos
Athens, 10676
University General Hospital of Heraklion
Heraklion, Crete, 71110
General Hospital of Rhodes
Rhodes, 85100
Croatia2 sites
Clinical Hospital Osijek
Osijek, 31000
Polyclinic Bonifarm
Zagreb, 10000
United Kingdom2 sites
Royal Bournemouth and Christchurch Hospital
Bournemouth, BH7 7DW
Walsall Manor Hospital
Walsall, WS2 9PS
Bosnia and Herzegovina1 site
University Clinical Centre Sarajevo
Sarajevo, 71000
About this study
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
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
- Being tested
- BI 695501, HUMIRA
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 695501Drug
HUMIRADrug
| Study group | Role | What they receive |
|---|---|---|
| BI 695501 | Experimental | Not described Receives: Drug: BI 695501 |
| HUMIRA + BI 695501 | Active comparator | Not described Receives: Drug: BI 695501; Drug: HUMIRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 4
Secondary outcomes (8)
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
The CDAI is a validated instrument to measure disease severity in 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 24 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 NRI and LOCF.
Measured: Week 24
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
The CDAI is a validated instrument to measure disease severity in 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.
Patients with CDAI <150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Measured: at Week 24
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Measured: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients With Infections
The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Measured: 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
The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Measured: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients Who Experienced Hypersensitivity Reactions
The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Measured: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Measured: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients With Injection Site Reactions
The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Measured: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start28 Sep 2016
- Primary completion30 Apr 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871635
- Sponsor's protocol ID
- 1297.4
- Other IDs
- 2016-000612-14, 2016
- Status last verified
- May 2020
- First submitted
- 15 Aug 2016
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 40498294Strand 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.
PubMed 39551590Hanauer 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.
PubMed 36511191Hanauer 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.
PubMed 34388360
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02871635
- Acronym / sponsor ID
- 1297.4
- Conditions
- Crohn Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 695501 | Experimental | Drug: BI 695501 |
| HUMIRA + BI 695501 | Active comparator | Drug: BI 695501, Drug: HUMIRA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:
- Further inclusion criteria apply
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 695501 | Drug | BI 695501, HUMIRA + BI 695501 |
| HUMIRA | Drug | HUMIRA + BI 695501 |
Primary outcome
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
Time frame: 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).
8 secondary outcomes
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
Time frame: Week 24
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
Time frame: at Week 24
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients With Infections
Time frame: 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
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients Who Experienced Hypersensitivity Reactions
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Percentage of Patients With Injection Site Reactions
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40498294Strand 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.
- Derived from this study: PubMed 39551590Strand 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.
- Derived from this study: PubMed 36511191Hanauer 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.
- Derived from this study: PubMed 34388360Hanauer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
92 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BI 695501 and HUMIRA in people with Crohn Disease, run by Boehringer Ingelheim at 92 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, Russia, Czechia, Poland, Ukraine and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871635, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.