Digestive Diseases & Nutrition

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Clinical Research

Current Studies

  • IBD 600 - NCT03162549 - Actively Enrolling

    Observational Patient Registry

    • Key Inclusion: Has a diagnosis of Ulcerative Colitis or Crohn’s Disease, has been prescribed or starting a new biologic or small molecule
    • Key Exclusion: Is participating or planning to participate in a double-blind randomized trial for an IBD drug.

    Principle Investigator: Michelle Rosario, MD

  • LATITUDE UC - NCT06254950 - Actively Enrolling

    A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis.

    • Key Inclusion: Male or female aged 18-75 years old with diagnosis of UC for at least 30 days
      •  Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
    • Key Exclusion: Participants who have failed 3 or more classes of advanced therapies.
      • Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study
      • Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.

    Principle Investigator: Michelle Rosario, MD

     

    ENDEAVOUR - NCT06398626 - Actively Enrolling

    An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis (ENDEAVOUR-UC)

    • Key Inclusion: 18-65 years at baseline
      • Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
    • Key Exclusion: The presence of clinical findings suggestive of Crohn's disease
      • Prior/Concomitant Therapy:
        • Any previous exposure to etrasimod, including participation in the etrasimod clinical program
        • Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
        • Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi [filgotinib, tofacitinib, or upadacitinib]) or with any other S1P receptor modulator

    Principle Investigator: Michelle Rosario, MD

     

    GA45330 (AMETRINE-2) - NCT06588855 - Actively Enrolling

    A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-2)

    • Key Inclusion: Confirmed diagnosis of UC
      • Moderately to severely active UC assessed by mMS
      • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
    • Key Exclusion: Presence of an ostomy or ileoanal pouch
      • Current diagnosis or suspicion of primary sclerosing cholangitis

    Principle Investigator: Scott Manski, MD

  • LATITUDE CD - NCT06233461 - Actively Enrolling

    A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

    • Key Inclusion: Age 18-75 yrs. Old with diagnosed CD for at least 30 days.
      • Must have inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.
    • Key Exclusion: Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
      • Have complications of CD that might require surgery during the study.
      • Participants with a current ostomy.
      • Participants who have failed 3 or more classes of advanced therapies.

    Principle Investigator: Michelle Rosario, MD

     

    MK7240-001(CD) - NCT06052059 - Actively Enrolling

    A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

    • Key Inclusion: Has moderately to severely active UC
    • Satisfies at least 1 of the following criteria:
      • Has had an inadequate response or loss to 1 or more protocol-specified UC treatments
      • Protocol specified corticosteroid dependence
      • Has been intolerant to 1 or more protocol-specified UC treatments
    • Key Exclusion: Has UC limited to the rectum
      • Current or impending need for colostomy or ileostomy
      • Has had a total proctocolectomy or partial colectomy
      • Has a transplanted organ which requires continued immunosuppression

    Principle Investigator: Michelle Rosario, MD

     

    MK7240-008 (CD) - NCT06430801 - Actively Enrolling

    A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

    • Key Inclusion: Has moderately to severely active CD.
      • Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
    • Key Exclusion: Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
      • Has current stoma or need for colostomy or ileostomy.
      • Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
      • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.

    Principle Investigator: Michelle Rosario, MD

     

    VICTRIVA - NCT06227910 - Actively Enrolling

    A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease (VICTRIVA)

    • Key Inclusion: The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
      • The participant has demonstrated an inadequate response to loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.
    • Key Exclusion: The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
      • The participant has an ostomy or ileoanal pouch.
      • The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.

    Principle Investigator: Scott Manski, MD

     

    GA45331 (SIBERITE-1) - NCT06819878 - Actively Enrolling

    A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease (SIBERITE-1)

    • Key Inclusion: Moderately to severely active CD
      • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
    • Key Exclusion: Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
      • Diagnosis of short gut or short bowel syndrome
      • Presence of an ileostomy, colostomy or ileoanal pouch
      • Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
      • Presence of abdominal or perianal abscess
      • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

    Principle Investigator: Scott Manski, MD

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