Clinical Trials

Stricturing CD Participant Criteria

Inclusion Criteria

• Adults ≥ 18 years of age at the time of informed consent.
• An established diagnosis of CD.
• Documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., a portion of the stricture is located within 15 cm of the ileocecal valve anastomosis).
• Anastomotic or naïve small bowel CD stricture(s) at the time of  clinically-indicated CT entergraphy (CTE[FJGM3] ) or MRE, where naïve small bowel stricture is defined by the combination of:
  • localized luminal narrowing (luminal diameter reduction of at least 50% relative to normal adjacent bowel loop);  AND
  • bowel wall thickening (25% increase relative to adjacent unaffected bowel); AND
  • Either: maximum associated small bowel dilation (luminal diameter greater than or equal to 3 cm; measured wall to wall) or inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation with unequivocal proximal small bowel dilation on CTE/CT/MRE/MRI (i.e., maximum associated small bowel dilation may be less than 3 cm). Endoscopic diagnosis of stricture should be within 1 year of SOC imaging if no GI surgery occurred between endoscopy and imaging.

Note: An anastomotic stricture is defined the same as a naïve stricture, but at the site of prior intestinal resection with anastomosis.

• Clinical symptoms consistent with obstruction (e.g., bloating, abdominal distension, abdominal cramping, dietary restrictions, nausea/vomiting, abdominal pain, and/or postprandial abdominal pain) within 1 year of the SOC imaging.
• Planned surgical resection (Aim 1) or ileocolonoscopy (Aim 2) of the small bowel stricture scheduled to occur as SOC within 3 months from the Screening Visit..

Exclusion Criteria

• Internal penetrating disease as shown by fistula, abscess, or inflammatory mass (phlegmon)[FJGM7] . A blind-ending sinus is not excluded.
• Gastrointestinal malignancies.
• More than 2 distal ileal strictures at the time of SOC MRE or CTE (where a long segment with multiple areas of narrowing with confluent inflammation between them is counted as 1 stricture, and 2 strictures within 3 cm are counted as a single stricture).
• A terminal ileal stricture in a patient with end ileostomy, where the stricture is confined within the subcutaneous tissues and does not extend intra-abdominally.
• A diverting loop ileostomy proximal to the dominant stricture.
• Total proctocolectomy with an ileoanal or Kock pouch.
• Stricturoplasty in the distal ileum, which is near or adjacent to a stricture[FJGM8].

UC Control Participant Criteria

Inclusion Criteria

• Adults ≥ 18 years of age at the time of informed consent
• An established diagnosis of UC, confirmed by endoscopy, histology, and cross-sectional imaging.
• Prior CTE, CT, MRE, or MRI up to 10 years prior to surgery or biopsy showing absence of small bowel inflammation and perianal disease, with no change in clinical status since the imaging procedure suggesting a diagnosis of CD.
• Planned surgical resection (Aim 1) or ileocolonoscopy (Aim 2) scheduled to occur as SOC within 3 months from the Screening Visit.

Exclusion Criteria

• Diagnosis of UC uncertain or indeterminate colitis
• Presence of a perianal fistula
• Total proctocolectomy with an ileoanal or Kock pouch.
• Diverting loop ileostomy prior to colectomy.
• Completion proctectomies after prior segmental colon resection or presence of a Hartmann’s pouch.

Non-IBD Control Participant Criteria

Inclusion Criteria

• Adults ≥ 18 years of age at the time of informed consent.
• Prior abdominopelvic CTE, CT, MRE, or MRI up to 10 years prior to surgery or biopsy showing lack of small bowel inflammation, segmental, or diffuse colitis and/or perianal disease, with no change in clinical status since the imaging procedure suggesting a diagnosis of CD.
• Planned surgical resection (Aim 1) or ileocolonoscopy (Aim 2) scheduled to occur as SOC within 3 months from the Screening Visit.

Exclusion Criteria

• Diagnosis of IBD.
• Total proctocolectomy with an ileoanal or Kock pouch.
• Diverting loop ileostomy upstream of resection.
• Ongoing chemotherapy or radiotherapy within 3 months of surgery.
• Completion proctectomies after prior segmental colon resection or presence of a Hartmann’s pouchy.
• Hereditary colorectal cancer (CRC) diagnosis. Sporadic cases of CRC are permitted to enroll.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/11/2025. Questions regarding updates should be directed to the study team contact.
 

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