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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04978493
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: BI 706321 Drug: ustekinumab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ustekinumab treatment is open-label for the Sponsor, patients and investigator/site staff.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : March 24, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 706321 + ustekinumab Drug: BI 706321
BI 706321

Drug: ustekinumab
ustekinumab
Placebo Comparator: Placebo + ustekinumab Drug: ustekinumab
ustekinumab

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at week 12 [ Time Frame: At week 12 ]
    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. A total score from 0 to 2 represents remission, 3 to 6 represents mild endoscopic activity, 7 to 15 represents moderate endoscopic activity and > 15 represents severe endoscopic activity.


Secondary Outcome Measures :
  1. Percent change in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12 [ Time Frame: At week 12 ]
    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. A total score from 0 to 2 represents remission, 3 to 6 represents mild endoscopic activity, 7 to 15 represents moderate endoscopic activity and > 15 represents severe endoscopic activity.

  2. Endoscopic response [ Time Frame: At week 12 ]
    defined as > 50 percent (%) SES-CD reduction from baseline or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline

  3. Endoscopic response [ Time Frame: At week 48 ]
    defined as > 50 percent (%) SES-CD reduction from baseline or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline

  4. Endoscopic remission [ Time Frame: At week 12 ]
    defined as SES-CD score of ≤ 2

  5. Endoscopic remission [ Time Frame: At week 48 ]
    defined as SES-CD score of ≤ 2

  6. Biological remission [ Time Frame: At week 12 ]
    defined as C-Reactive Protein (CRP) < 5 milligrams/Litre (mg/L) and faecal calprotectin (FCP) < 250 micrograms/gram (ug/g)

  7. Biological remission [ Time Frame: At week 48 ]
    defined as C-Reactive Protein (CRP) < 5 milligrams/Litre (mg/L) and faecal calprotectin (FCP) < 250 micrograms/gram (ug/g)

  8. Clinical remission [ Time Frame: At week 12 ]
    defined as a Crohn's Disease Activity Index (CDAI) score of < 150 CDAI is comprised of eight variables which are summed after adjustment with a weighting factor. A CDAI score of ≤ 150 represents remission, 151 to 219 represents mild activity, 220 to 450 represents moderate activity and a score of > 450 represents severe or very severe activity.

  9. Clinical remission [ Time Frame: At week 48 ]
    defined as a Crohn's Disease Activity Index (CDAI) score of < 150

  10. Clinical response [ Time Frame: At week 12 ]
    defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of < 150

  11. Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the REP period [ Time Frame: Up to 104 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978493


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04978493    
Other Study ID Numbers: 1425-0003
2020-004527-16 ( EudraCT Number )
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents