Testing the effect of the new drug on Crohn’s Disease

Recruting new patients

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    What is this study about?

    This study is exploring a new medication for Crohn’s disease, an ailment of the gut. The medication, known as BI 706321, is given alongside another medication called Ustekinumab that is already used to treat Crohn’s. The trial is conducted to see if this combination helps to manage the disease better. Participants will be split into two groups. One group will be given the new medication and the other will receive a placebo, alongside Ustekinumab. Participating in this study will last for 1 year. During this time, participants will have about 13 visits to the clinic. Some visits will involve a colonoscopy where doctors look at the intestine’s condition. Their findings will help doctors understand if the new treatment is working.

    Learn more about this Trial

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      Where does the clinical trial take place?

      Bruxelles , Belgium

      Gent , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liu00e8ge , Belgium

      Mons , Belgium

      Hradec Kralove , Czechia

      Ostrava , Czechia

      Ku00f8ge , Denmark

      Odense C , Denmark

      u00c5lborg , Denmark

      Berlin , Germany

      Berlin , Germany

      Braunschweig , Germany

      Dresden , Germany

      Kiel , Germany

      Mannheim , Germany

      Ulm , Germany

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Gyongyos , Hungary

      Catanzaro , Italy

      Milano , Italy

      Milano , Italy

      Negrar (VR) , Italy

      Pavia , Italy

      Rho (mi) , Italy

      Roma , Italy

      San Donato Milanese (MI) , Italy

      Dordrecht , Netherlands

      Groningen , Netherlands

      Nijmegen , Netherlands

      Tilburg , Netherlands

      Bydgoszcz , Poland

      Knurow , Poland

      Krakow , Poland

      Ksawerow , Poland

      Lublin , Poland

      Szczecin , Poland

      Szczecin , Poland

      Warsaw , Poland

      Warsaw , Poland

      Zamosc , Poland

      Cordoba , Spain

      Madrid , Spain

      Sabadell , Spain

      Sevilla , Spain

      Valencia , Spain

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial are:

      1. Take BI 706321 or placebo as tablets every day. It’s noted that placebo tablets look like the BI 706321 tablets but do not contain medicine.
      2. Ustekinumab is administered as an infusion into a vein once at the beginning of the study.
      3. After the initial infusion, participants receive ustekinumab as an injection under the skin every 2 months.
      4. Participants will take BI 706321 or placebo in combination with ustekinumab for the first 3 months.
      5. For the subsequent 9 months, participants will receive only ustekinumab.
      6. The total duration of participation in the study is about 1 year, during which participants will visit the study site about 13 times.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on diseases, you need to have been diagnosed with Crohn’s Disease (CD) for at least 3 months prior to Visit 1. The diagnosis should be confirmed by endoscopy and/or radiology, and supported by histology.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      1. Diagnosis of Crohn’s Disease (CD): You must have been diagnosed with Crohn’s Disease for at least 3 months prior to the first visit. The diagnosis should be confirmed by endoscopy and/or radiology, and supported by histology.
      2. Elevated C-reactive protein (≥ 5 mg/L) or elevated fecal calprotectin (≥ 250 µg/g): C-reactive protein is a marker in the blood that indicates inflammation, while fecal calprotectin is a protein found in stool that can indicate inflammation in the intestine. Elevated levels of either of these suggest active inflammation in the body.
      3. Symptomatic Crohn’s Disease: Your symptoms must be defined as a Crohn’s Disease Activity Index (CDAI) of ≥150. CDAI is a scale that measures the severity of symptoms in Crohn’s Disease, with a score of 150 or above indicating active disease.
      4. Presence of mucosal ulcers: You must have 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, a score ≥4 is sufficient. The SES-CD assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension, and the presence of stenosis. Each variable is scored from 0 to 3 for different parts of the intestine, and higher scores indicate more severe disease.
      5. Experience with tumor necrosis factor (TNF) antagonists: You must have had treatment with at least one TNF antagonist at a dose approved for CD. You may have stopped treatment because it wasn’t working (primary or secondary non-responsiveness), or due to intolerance or other reasons.
      6. Medication requirements: If you are receiving any of the following, they must be at a therapeutic and stable dose:
        1. Oral 5-aminosalicylic acid (5-ASA) compounds must have been at a stable dose for at least 4 weeks prior to randomization.
        2. Oral corticosteroids, if being taken for CD, should be at a prednisone equivalent dose of ≤ 20 mg/day, or ≤ 9 mg/day of budesonide, and stable for at least 2 weeks before randomization.
        3. Azathioprine (AZA), mercaptopurine (MP), or methotrexate (MTX) must have a stable dose for 8 weeks before randomization.
      7. Birth control: Women of childbearing potential must be ready and able to use highly effective methods of birth control.

      There may be further inclusion criteria that apply to the study.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that can exclude you from taking part in the study, with explanations of medical terms provided:

      Exclusion Criteria:

      1. Current or prior abscesses: An abscess is a pocket of pus that can form in any part of the body as a result of infection. Unless abscesses have been drained and treated at least 6 weeks prior to randomisation without the need for surgery, you cannot participate.
      2. Complications of Crohn’s Disease (CD): This includes strictures (narrowing of the bowel), stenosis (abnormal narrowing of a passage in the body), short bowel syndrome (a condition resulting from the removal of a large part of the small intestine), or other conditions that might require surgery or affect the assessment of the disease or treatment response.
      3. Inflammatory Bowel Disease (IBD) diagnosis other than CD: If you have been diagnosed with a type of IBD that isn’t Crohn’s Disease, you are not eligible.
      4. Recent bowel resection or diversion surgery: If you had any bowel surgery within 4 months or any abdominal surgery within 3 months prior to Visit 1, or currently have an ileostomy, colostomy, or ileorectal anastomosis, you are excluded.
      5. Certain medications for IBD: Treatment with non-biologic medications such as tacrolimus or mycophenolate mofetil, systemic corticosteroids (other than allowed ones), biologic treatments with TNF-alpha antagonists, vedolizumab, a previous treatment with ustekinumab, JAK inhibitors, S1P modulators, IL-23 inhibitors, antiintegrins, or any investigational drug other than CD during the course of the actual study, or prior exposure to rituximab within 1 year prior to randomisation.
      6. Infection with C difficile or other intestinal pathogens: If you have a positive stool examination for Clostridium difficile or other pathogenic bacteria within 30 days prior to randomization, you cannot participate.
      7. Colonic mucosal dysplasia or adenomas: These are precancerous conditions in the colon; participants with moderate to severe dysplasia or adenomas are excluded unless these lesions have been properly removed.
      8. Increased risk of infectious complications: This can include a recent bacterial infection, any congenital or acquired immunodeficiency (like HIV), past organ or stem cell transplantation (except for corneal transplant over 12 weeks prior to screening), or prior stem cell therapy. Specific cell therapy products like Alofisel aren’t excluded if administered over 8 weeks prior to randomisation.
      9. Recent vaccination: Live or attenuated vaccines received within 4 weeks prior to randomisation can exclude you from the study.
      10. Clinically significant infections: This includes chronic infections like viral hepatitis, COVID-19, or others that the investigator deems significant.
      11. QT/QTc interval prolongation: This is a measurement from an electrocardiogram (ECG) that reflects the heart’s electrical system’s recovery after each beat. If your QTcF intervals are greater than 450 ms for men, 470 ms for female, or you have other relevant ECG findings, you are excluded.

      I hope this list and explanations help you understand if you are eligible for the study.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. BI 706321: This is a medicine being developed to treat Crohn’s disease.
      2. Ustekinumab: This is a medicine already used to treat Crohn’s disease. Ustekinumab, which is known by the trade name Stelara, is an interleukin-12 and interleukin-23 antagonist.

      Ustekinumab (Stelara) is an immunosuppressant that works by blocking certain substances in the body that can cause inflammation and immune system reactions. It is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves two active substances:

      1. BI 706321: This is a medicine being developed to treat Crohn’s disease. It is currently being analyzed in the trial to assess its efficacy and safety.
      2. Ustekinumab: This is a medicine that is already known to medicine and the medical literature, as it is already used to treat Crohn’s disease.

      Study ID


      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago