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

NCT ID NCT04978493

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

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.

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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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