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New pill plus injection shows promise for Crohn's – but trial halted early

NCT ID NCT04978493

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether adding an experimental oral drug (BI 706321) to the standard treatment ustekinumab helps people with moderate to severe Crohn's disease. About 49 adults took either the combination or a placebo plus ustekinumab for 12 weeks, followed by ustekinumab alone. The trial was terminated early, so results are limited, but researchers looked at changes in bowel inflammation and overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 706321 (an experimental oral drug) plus ustekinumab (an approved injectable drug)
What this could lead to
If it works, this combination could offer a new treatment option for people with moderate to severe Crohn's disease.
What could go wrong
This is an early (Phase 2) trial that was terminated, so results may be limited. The added benefit of BI 706321 over ustekinumab alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (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

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

Contacts and locations

Locations

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • AZ Sint-Lucas - Campus Sint Lucas

    Ghent, 9000, Belgium

  • Aalborg Sygehus Syd

    Aalborg, 9100, Denmark

  • Advanced Research Institute, Inc.

    Orlando, Florida, 32825, United States

  • Az. Ospedaliera Universitaria Polic.Tor Vergata

    Roma, 00133, Italy

  • BVL Clinical Research

    Liberty, Missouri, 64068, United States

  • Brussels - UNIV St-Pierre

    Brussels, 1000, Belgium

  • Bugat Pal Hospital, Gyongyos

    Gyöngyös, 3200, Hungary

  • CEIC Corporacio Sanitaria Parc Taulí

    Sabadell, 08208, Spain

  • California Medical Research Associates Inc.

    Northridge, California, 91324, United States

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834, United States

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

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

    Ksawerów, 95-054, Poland

  • Clinexpert Kft.

    Budapest, 1033, Hungary

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100, Italy

  • GI Alliance

    Southlake, Texas, 76092, United States

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519, United States

  • Healthcare Center Gastromed - SCANMED GROUP

    Lublin, 20-582, Poland

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 50002, Czechia

  • Hospital La Princesa

    Madrid, 28006, Spain

  • Hospital Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Virgen Macarena

    Seville, 41071, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • I.H.S Health, LLC

    Kissimmee, Florida, 34741, United States

  • IRCCS Fondazione Ospedale Maggiore

    Milan, 20122, Italy

  • IRCCS Policlinico San Donato

    San Donato Milanese (MI), 20097, Italy

  • IRCCS San Raffaele

    Milan, 20132, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190, Poland

  • NZOZ Medical Center KERmed

    Bydgoszcz, 85231, Poland

  • National Medical Institute MSWiA

    Warsaw, 02-507, Poland

  • Nature Coast Clinical Research

    Inverness, Florida, 34452, United States

  • Osp.Sacro Cuore-Don Calabria

    Negrar (VR), 37024, Italy

  • Policlinico Universitario Mater Domini, Universita di Catanzaro

    Catanzaro, 88100, Italy

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229, United States

  • St Elisabeth Ziekenhuis

    Tilburg, 5022 GC, Netherlands

  • Sweet Hope Research Specialty Inc

    Hialeah, Florida, 33016, United States

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434, Poland

  • UNIV Ambroise Paré

    Mons, 7000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hospital Ostrava

    Ostrava, 708 52, Czechia

  • University of Debrecen Clinical Centre

    Debrecen, 4032, Hungary

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • payee-Hospital Universitario Reina Sofia. Cordoba

    Córdoba, 14004, Spain

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