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

XmAb942-01- NCT06619990: Actively Enrolling

A Study in Healthy participants followed by a Study in participants with Moderate-to-Severe Active Ulcerative Colitis.

• Key Inclusion: 18-75 years of age at baseline

  • Evidence of UC extending ≥ 15cm from the anal verge, determined by colonoscopy

  • Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies for UC.

• Key Exclusion: Known colonic stricture and participants with history of colonic or small bowel obstruction

  • Having previously received anti-TL1A therapy

  • Who have failed more than 3 individual (not classes o) advanced therapies

Principle Investigator: Michelle Rosario, 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

MK7240-008 (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: Michelle Rosario, 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: Michelle Rosario, MD