A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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: - 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.

Exclusion Criteria:

  • - 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.
  • - Any biologic treatment with a TNF-alpha antagonist (adalimumab, infliximab, golimumab, certolizumab pegol) or vedolizumab within 4 weeks prior to randomisation.
  • - Any previous treatment with ustekinumab.
  • - Any previous treatment with an investigational non[1]biologic or biologic drug for CD (including but not limited to JAK inhibitors, S1P modulators, interleukin (IL)-23 inhibitors, anti-integrins).
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04978493
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Czechia, Italy, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: BI 706321 + ustekinumab

Placebo Comparator: Placebo + ustekinumab

Interventions

Drug: - BI 706321

BI 706321

Drug: - ustekinumab

ustekinumab

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northridge, California

Status

Recruiting

Address

California Medical Research Associates Inc.

Northridge, California, 91324

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Hamden, Connecticut

Status

Recruiting

Address

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Sweet Hope Research Specialty Inc, Hialeah, Florida

Status

Recruiting

Address

Sweet Hope Research Specialty Inc

Hialeah, Florida, 33016

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Nature Coast Clinical Research, Inverness, Florida

Status

Recruiting

Address

Nature Coast Clinical Research

Inverness, Florida, 34452

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

I.H.S Health, LLC, Kissimmee, Florida

Status

Recruiting

Address

I.H.S Health, LLC

Kissimmee, Florida, 34741

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Decatur, Georgia

Status

Recruiting

Address

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Clinical Research Inst of MI, Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Inst of MI

Chesterfield, Michigan, 48047

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Wyoming, Michigan

Status

Recruiting

Address

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

BVL Clinical Research, Liberty, Missouri

Status

Recruiting

Address

BVL Clinical Research

Liberty, Missouri, 64068

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey

Status

Recruiting

Address

AGA Clinical Research Associates, LLC

Egg Harbor Township, New Jersey, 08234

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Carolina Digestive Diseases, Greenville, North Carolina

Status

Recruiting

Address

Carolina Digestive Diseases

Greenville, North Carolina, 27834

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Houston Methodist Hospital, Houston, Texas

Status

Recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Southern Star Research Institute, LLC, San Antonio, Texas

Status

Recruiting

Address

Southern Star Research Institute, LLC

San Antonio, Texas, 78229

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Fairfax, Virginia

Status

Recruiting

Address

Clinical Research & Consulting Center, LLC

Fairfax, Virginia, 22031

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

International Sites

Brussels - UNIV St-Pierre, Bruxelles, Belgium

Status

Recruiting

Address

Brussels - UNIV St-Pierre

Bruxelles, , 1000

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

AZ Maria Middelares, Gent, Belgium

Status

Recruiting

Address

AZ Maria Middelares

Gent, , 9000

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

AZ Sint-Lucas - Campus Sint Lucas, Gent, Belgium

Status

Recruiting

Address

AZ Sint-Lucas - Campus Sint Lucas

Gent, , 9000

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Liège, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire de Liège

Liège, , 4000

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia

Status

Recruiting

Address

Fakultni nemocnice u sv. Anny v Brne

Brno, , 65691

Site Contact

Boehringer Ingelheim

cesko@bitrialsupport.com

800142046

University Hospital Ostrava, Ostrava, Czechia

Status

Recruiting

Address

University Hospital Ostrava

Ostrava, , 708 52

Site Contact

Boehringer Ingelheim

cesko@bitrialsupport.com

800142046

Catanzaro, Italy

Status

Recruiting

Address

Policlinico Universitario Mater Domini, Universita di Catanzaro

Catanzaro, , 88100

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

IRCCS Fondazione Ospedale Maggiore, Milano, Italy

Status

Recruiting

Address

IRCCS Fondazione Ospedale Maggiore

Milano, , 20122

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

Osp.Sacro Cuore-Don Calabria, Negrar (VR), Italy

Status

Recruiting

Address

Osp.Sacro Cuore-Don Calabria

Negrar (VR), , 37024

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

Ospedale di Circolo, Rho (mi), Italy

Status

Recruiting

Address

Ospedale di Circolo

Rho (mi), , 20017

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

NZOZ Medical Center KERmed, Bydgoszcz, Poland

Status

Recruiting

Address

NZOZ Medical Center KERmed

Bydgoszcz, , 85231

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Knurow, Poland

Status

Recruiting

Address

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurow, , 44-190

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Medical Center Plejady, Krakow, Poland

Status

Recruiting

Address

Medical Center Plejady

Krakow, , 30-363

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Ksawerow, Poland

Status

Recruiting

Address

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska sp. j.

Ksawerow, , 95-054

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Szczecin, Poland

Status

Recruiting

Address

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , 71-434

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Warsaw, Poland

Status

Recruiting

Address

Central Clinical Hospital MSWiA, Internal Diseases, Warsaw

Warsaw, , 02-507

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

Warsaw, Poland

Status

Recruiting

Address

Non-Public Outpatient Medical Care VIVAMED, Warsaw

Warsaw, , 03-580

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

ETG Zamosc, Zamosc, Poland

Status

Recruiting

Address

ETG Zamosc

Zamosc, , 22400

Site Contact

Boehringer Ingelheim

polska@bitrialsupport.com

008001218830

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