Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Study Identifier
M24-885
CT.gov Identifier
NCT06548542
EudraCT Identifier
Not available
EUCTIS ID
2024-513009-30-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • Risankizumab
  • Lutikizumab
  • Trosunilimab
  • ABBV-8736
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants' body weight must be \>= 40 kg at Baseline. * Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available. * CDAI \>= 220 at Baseline. * Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader. * Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
    Exclusion Criteria:
    * Participant who demonstrated intolerance to p19 inhibitors, including risankizumab. * Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline. * Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

    Protocol Summary

    Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

    The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.

    Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.

    There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

    Study Locations

    Location
    Status
    Location
    Digestive Health Specialists /ID# 266216
    Dothan, Alabama, United States, 36301
    Status
    Recruiting
    Location
    East View Medical Research /ID# 270377
    Mobile, Alabama, United States, 36606
    Status
    Recruiting
    Location
    Southern California Res. Ctr /ID# 265549
    Coronado, California, United States, 92118
    Status
    Recruiting
    Location
    UC San Diego Health System /ID# 265565
    La Jolla, California, United States, 92037
    Status
    Recruiting
    Location
    uc davis medical center - patient support services building /ID# 265554
    Sacramento, California, United States, 95817
    Status
    Recruiting
    Location
    Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
    San Diego, California, United States, 92103
    Status
    Recruiting
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