Crohn DiseasePhase 2NCT04978493
A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
A Phase 2 study testing BI 706321 and Ustekinumab in people with Crohn Disease, run by Boehringer Ingelheim at 49 sites in 11 countries.
Trial summary
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease. The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- BI 706321 and Ustekinumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 49 sitesin 11 countries
- Study dates
- 2 Dec 2021to 8 Aug 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Crohn Disease (CD) for at least 3 months prior to visit 1, as confirmed at any time in the past by endoscopy and/OR, radiology, and supported by histology.
- Elevated C-reactive protein (≥ 5 mg/L) OR elevated fecal calprotectin (≥ 250 µg/g)
- Symptomatic CD defined as Crohn's Disease Activity Index (CDAI) ≥150.
- Presence of mucosal ulcers in at least one segment of the ileum or colon and a Simple Endoscopic Score for Crohn's disease (SES-CD) score ≥ 7 (for patients with isolated ileitis ≥4).
- Patients who are experienced at least 1 tumor necrosis factor (TNF) antagonists at a dose approved for CD. Patients may have stopped TNF antagonist treatment due to primary or secondary non-responsiveness, intolerance, or for other reasons.
- May be receiving a therapeutic dose of the following:
Show all 11Show fewer
- Oral 5-aminosalicylic acid (5-ASA) compounds must have been at a stable dose for at least 4 weeks prior to randomisation and must continue on this dose until week 12 and/or
- Oral corticosteroids if indicated for treatment of CD must be at a prednisone equivalent dose of ≤ 20 mg/day, or ≤ 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks immediately prior to randomisation and must continue on this dose until week 12. and/or
- Azathioprine (AZA), mercaptopurine (MP), or methotrexate (MTX), provided that dose has been stable for the 8 weeks immediately prior to randomisation and must continue on this dose until week 12.
- Women of childbearing potential must be ready and able to use highly effective methods of birth control.
- Further inclusion criteria apply
Who cannot join
- Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomisation and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present based on investigator's judgement.
- Have complications of CD such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery, or could preclude the use of SES-CD/CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 706321 (based on investigator's judgement).
- Patient with an inflammatory bowel disease (IBD) diagnosis other than CD.
- Have had any kind of bowel resection or diversion within 4 months or any other intra-abdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded.
- Treatment with:
- Any non-biologic medication for IBD (e.g.tacrolimus or mycophenolate mofetil, systemic corticosteroids), other than those allowed per inclusion criteria, within 30 days prior to randomisation
Show all 18Show fewer
- Any biologic treatment with a TNF-alpha antagonist (adalimumab, infliximab, golimumab, certolizumab pegol) or vedolizumab (or a biosimilar of these drugs) within 4 weeks prior to randomisation. (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomisation, patient can be enrolled despite not having completed 4 week from last treatment.)
- Any previous treatment with ustekinumab (or a biosimilar of this drug)
- Any previous treatment with an investigational (or subsequently approved) non-biologic/biologic drug for CD (including but not limited to JAK inhibitors [e.g. upadacitinib], S1P modulators, IL-23 inhibitors [e.g. risankizumab], antiintegrins).
- Any investigational drug for an indication other than CD during the course of the actual study and within 30 days or 5 half-lives (whichever is longer) prior to randomisation.
- Any prior exposure to rituximab within 1 year prior to randomisation.
- Positive stool examination for C difficile or other intestinal pathogens <30 days prior to randomization
- Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed
- Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. human immunodeficiency virus (HIV)), past organ or stem cell transplantation (with exception of a corneal transplant > 12 weeks prior to screening) or have ever received stem cell therapy (e.g., Prochymal). Prior treatment with a somatic cell therapy product (e.g., Alofisel) is not excluded, provided it was administered > 8 weeks prior to randomisation.
- Live or attenuated vaccination within 4 weeks prior to randomisation.
- Presence of clinically significant acute or chronic infections not otherwise listed, including viral hepatitis, COVID-19, or others based on investigator's judgement.
- A marked baseline prolongation of QT/QTc interval (such as QTcF intervals that are greater than 450 ms for men, 470 ms for female) or any other relevant electrocardiogram (ECG) finding at screening. Both have to be confirmed by repeated ECG recording.
- Further exclusion criteria apply
Trial locations and contacts
49 sites in 11 countries.
49 sites in 11 countries
United States15 sites
Rush University Medical Center
Chicago, Illinois, 60612
Carolina Digestive Diseases
Greenville, North Carolina, 27834
Sweet Hope Research Specialty Inc
Hialeah, Florida, 33016
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Nature Coast Clinical Research
Inverness, Florida, 34452
I.H.S Health, LLC
Kissimmee, Florida, 34741
BVL Clinical Research
Liberty, Missouri, 64068
California Medical Research Associates Inc.
Northridge, California, 91324
Advanced Research Institute, Inc.
Orlando, Florida, 32825
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98195
GI Alliance
Southlake, Texas, 76092
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
Italy7 sites
Policlinico Universitario Mater Domini, Universita di Catanzaro
Catanzaro, 88100
IRCCS Fondazione Ospedale Maggiore
Milan, 20122
IRCCS San Raffaele
Milan, 20132
Osp.Sacro Cuore-Don Calabria
Negrar (VR), 37024
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Az. Ospedaliera Universitaria Polic.Tor Vergata
Roma, 00133
IRCCS Policlinico San Donato
San Donato Milanese (MI), 20097
Belgium6 sites
Brussels - UNIV St-Pierre
Brussels, 1000
AZ Maria Middelares
Ghent, 9000
AZ Sint-Lucas - Campus Sint Lucas
Ghent, 9000
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
UNIV Ambroise Paré
Mons, 7000
Poland6 sites
NZOZ Medical Center KERmed
Bydgoszcz, 85231
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska sp. j.
Ksawerów, 95-054
Healthcare Center Gastromed - SCANMED GROUP
Lublin, 20-582
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
National Medical Institute MSWiA
Warsaw, 02-507
Spain5 sites
payee-Hospital Universitario Reina Sofia. Cordoba
Córdoba, 14004
Hospital La Princesa
Madrid, 28006
CEIC Corporacio Sanitaria Parc Taulí
Sabadell, 08208
Hospital Virgen Macarena
Seville, 41071
Hospital Politècnic La Fe
Valencia, 46026
Hungary3 sites
Clinexpert Kft.
Budapest, 1033
University of Debrecen Clinical Centre
Debrecen, 4032
Bugat Pal Hospital, Gyongyos
Gyöngyös, 3200
Czechia2 sites
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50002
University Hospital Ostrava
Ostrava, 708 52
Netherlands2 sites
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
St Elisabeth Ziekenhuis
Tilburg, 5022 GC
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease.
The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease.
Read more
Participants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab.
Participants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months.
Participants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Crohn Disease
- Being tested
- BI 706321, Ustekinumab, Placebo
- 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 706321Drug
One dose of 8 mg as tablets orally once per day in the morning
UstekinumabDrug
A single intravenous infusion of 260 mg (body weight ≤55 kg), 390 mg (body weight 55-85 kg), or 520 mg (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg every 8 weeks.
PlaceboDrug
One dose of placebo matching BI 706321 as tablets orally once per day in the morning
| Study group | Role | What they receive |
|---|---|---|
| BI 706321 and ustekinumab | Experimental | Participants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.
A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram [kg]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks. Receives: Drug: BI 706321; Drug: Ustekinumab |
| Placebo and ustekinumab | Placebo comparator | Participants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks.
A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram [kg]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks. Receives: Drug: Ustekinumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.
Measured: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Secondary outcomes (11)
Percent Change in SES-CD From Baseline at Week 12
Percent change in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.
Measured: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 12
Percentage of patients with endoscopic response (defined as >50% Simple Endoscopic Score for Crohn's disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 48
Percentage of patients with endoscopic response (defined as >50% Simple Endoscopic Score for Crohn's disease (SES-CD) reduction from baseline, or for an induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: Within 28 days before randomization (baseline) and 48 weeks after first drug administration.
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 12
Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease (SES-CD) score of ≤2) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 48
Percentage of patients with endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease (SES-CD) score of ≤2) at Week 48 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: 48 weeks after first drug administration.
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 12
Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) < 5 mg/L and faecal calprotectin (FCP) < 250 ug/g at Week 12 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: 12 weeks after first drug administration.
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 48
Percentage of patients with biological remission, defined as C-Reactive Protein (CRP) < 5 mg/L and faecal calprotectin (FCP) < 250 ug/g at Week 48 is reported. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: 48 weeks after first drug administration.
Percentage of Patients With Clinical Remission at Week 12, Defined as a Crohn's Disease Activity Index (CDAI) Score of <150
Percentage of patients with clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of <150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: Data was collected for 7 days prior to 12 weeks after first drug administration.
Percentage of Patients With Clinical Remission at Week 48, Defined as a CDAI Score of <150
Percentage of patients with clinical remission at Week 48, defined as a CDAI score of <150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: Data was collected for 7 days prior to 48 weeks after first drug administration.
Percentage of Patients With Clinical Response at Week 12, Defined by a CDAI Reduction From Baseline of at Least 100 Points, or a CDAI Score of <150
Percentage of patients with clinical response at Week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of <150 is reported. The CDAI is comprised of eight variables which are summed after adjustment with a weighting factor, and the total score ranges from 0 to approximately 600, with higher scores indicating more severe disease. For certain variables (daily number of liquid or very soft stools, daily abdominal pain, daily general well-being, fever over 37.8 Celsius, taking medication for diarrhea) the average over 7 days was taken. The method to provide confidence intervals for single proportions is based on the Wilson method.
Measured: Within 28 days before randomization (baseline) and for 7 days prior to 12 weeks after first drug administration.
Number of Patients With Treatment-emergent Adverse Event (TEAE) Through End of Treatment (EoT) and the REP Period
Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period is reported.
Measured: From first drug administration until 16 days after last drug administration, up to 27 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start2 Dec 2021
- Primary completion8 Jul 2024
- Study completion8 Aug 2024
Why it stopped: Company decision
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ustekinumab treatment is open-label for the Sponsor, patients and investigator/site staff.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978493
- Sponsor's protocol ID
- 1425-0003
- Other IDs
- 2020-004527-16
- Status last verified
- Aug 2025
- First submitted
- 26 Jul 2021
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment
- ClinicalTrials.gov ID
- NCT04978493
- Acronym / sponsor ID
- 1425-0003
- Conditions
- Crohn Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults, aged 18-75 years, with moderate to severe Crohn's disease.
The purpose of this study is to find out whether BI 706321 combined with ustekinumab helps people with Crohn's disease. BI 706321 is a medicine being developed to treat Crohn's disease. Ustekinumab is a medicine already used to treat Crohn's disease.
Participants are put into 2 groups randomly, which means by chance. One group gets BI 706321 and ustekinumab. The other group gets placebo and ustekinumab.
Participants take BI 706321 or placebo as tablets every day. Placebo tablets look like BI 706321 tablets but do not contain any medicine. Ustekinumab is given as an infusion into a vein once at the beginning of the study. After that, ustekinumab is given as an injection under the skin every 2 months. Participants take BI 706321 or placebo in combination with ustekinumab for 3 months. After that, participants receive only ustekinumab for another 9 months.
Participants are in the study for about 1 year. During this time, they visit the study site about 13 times. At 3 of the visits, doctors do a colonoscopy to examine the bowel. The results from the colonoscopies are compared between the 2 groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Ustekinumab treatment is open-label for the Sponsor, patients and investigator/site staff.
| Arm | Type | Receives |
|---|---|---|
| BI 706321 and ustekinumab | Experimental | Drug: BI 706321, Drug: UstekinumabParticipants with moderately to severely active Crohn's Disease (CD) administered one dose of 8 milligram (mg) BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks. A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram [kg]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks. |
| Placebo and ustekinumab | Placebo comparator | Drug: Ustekinumab, Drug: PlaceboParticipants with moderately to severely active CD administered one dose of placebo matching BI 706321 as tablets orally once per day in the morning for 12 weeks in conjunction with standard induction dosing of ustekinumab, followed by ustekinumab maintenance dosing for an additional 36 weeks. A single intravenous infusion of 260 mg ustekinumab (body weight ≤55 kilogram [kg]), 390 mg ustekinumab (body weight 55-85 kg), or 520 mg ustekinumab (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg ustekinumab every 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of Crohn Disease (CD) for at least 3 months prior to visit 1, as confirmed at any time in the past by endoscopy and/OR, radiology, and supported by histology.
- Elevated C-reactive protein (≥ 5 mg/L) OR elevated fecal calprotectin (≥ 250 µg/g)
- Symptomatic CD defined as Crohn's Disease Activity Index (CDAI) ≥150.
- Presence of mucosal ulcers in at least one segment of the ileum or colon and a Simple Endoscopic Score for Crohn's disease (SES-CD) score ≥ 7 (for patients with isolated ileitis ≥4).
- Patients who are experienced at least 1 tumor necrosis factor (TNF) antagonists at a dose approved for CD. Patients may have stopped TNF antagonist treatment due to primary or secondary non-responsiveness, intolerance, or for other reasons.
Key exclusion criteria (18 listed)
- Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomisation and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present based on investigator's judgement.
- Have complications of CD such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery, or could preclude the use of SES-CD/CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 706321 (based on investigator's judgement).
- Patient with an inflammatory bowel disease (IBD) diagnosis other than CD.
- Have had any kind of bowel resection or diversion within 4 months or any other intra-abdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded.
- Treatment with:
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 706321One dose of 8 mg as tablets orally once per day in the morning | Drug | BI 706321 and ustekinumab |
| UstekinumabA single intravenous infusion of 260 mg (body weight ≤55 kg), 390 mg (body weight 55-85 kg), or 520 mg (body weight >85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg every 8 weeks. | Drug | BI 706321 and ustekinumab, Placebo and ustekinumab |
| PlaceboOne dose of placebo matching BI 706321 as tablets orally once per day in the morning | Drug | Placebo and ustekinumab |
Primary outcome
Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time frame: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12 is reported. The SES-CD is a numerical grading system composed of 4 variables (presence of ulcers, ulcerated surface, affected surface, presence of narrowings) recorded sequentially in 5 segments: rectum, left colon, transverse colon, right colon, ileum. Each variable is assigned a value from 0 to 3, and the total score, ranging from 0 to 56, is obtained by adding each variable. Higher values indicate worse endoscopic inflammation. To achieve a score of 56, the maximum score for the "presence of narrowings" variable has to be be 2 (not 3) for the four segments leading up to the ileum. The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.
11 secondary outcomes
Percent Change in SES-CD From Baseline at Week 12
Time frame: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 12
Time frame: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Response (Defined as >50% SES-CD Reduction From Baseline, or for an Induction Baseline SES-CD of 4, at Least a 2 Point Reduction From Induction Baseline) at Week 48
Time frame: Within 28 days before randomization (baseline) and 48 weeks after first drug administration.
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 12
Time frame: 12 weeks after first drug administration.
Percentage of Patients With Endoscopic Remission (Defined as SES-CD Score of ≤2) at Week 48
Time frame: 48 weeks after first drug administration.
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 12
Time frame: 12 weeks after first drug administration.
Percentage of Patients With Biological Remission, Defined as C-Reactive Protein (CRP) < 5 mg/L and Faecal Calprotectin (FCP) < 250 ug/g at Week 48
Time frame: 48 weeks after first drug administration.
Percentage of Patients With Clinical Remission at Week 12, Defined as a Crohn's Disease Activity Index (CDAI) Score of <150
Time frame: Data was collected for 7 days prior to 12 weeks after first drug administration.
Percentage of Patients With Clinical Remission at Week 48, Defined as a CDAI Score of <150
Time frame: Data was collected for 7 days prior to 48 weeks after first drug administration.
Percentage of Patients With Clinical Response at Week 12, Defined by a CDAI Reduction From Baseline of at Least 100 Points, or a CDAI Score of <150
Time frame: Within 28 days before randomization (baseline) and for 7 days prior to 12 weeks after first drug administration.
Number of Patients With Treatment-emergent Adverse Event (TEAE) Through End of Treatment (EoT) and the REP Period
Time frame: From first drug administration until 16 days after last drug administration, up to 27 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
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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.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 706321 and Ustekinumab in people with Crohn Disease, run by Boehringer Ingelheim at 49 sites in 11 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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Italy, Belgium, Poland, Spain and 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sep 2025). 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?
Absolute Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 (time frame: Within 28 days before randomization (baseline) and 12 weeks after first drug administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.