Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg,
clinical, endoscopic, and histologic evidence) established at least 3 months prior to
screening.
2. Presence of up to 2 ileal stricture(s) which should be noncritical naive or
anastomotic stricture(s), caused by CD and with at least 1 stricture located in the
(neo)terminal ileum within reach of an endoscope and confirmed centrally by MRE
according to the following criteria:
- localized luminal narrowing (luminal diameter ≤50% relative to normal adjacent
bowel); AND
- bowel wall thickening (≥ 25% relative to adjacent bowel).
3. Presence of tolerable obstructive symptoms (such as abdominal pain, abdominal pain
after eating, limitations in amount or types of food, etc.), and not expected to
require hospitalization, endoscopic balloon dilation, surgical resection, or
additional therapy during the study. Participants should have sufficient food intake,
even with diet modification.
4. Stable background therapy for CD and agree to maintain background therapy for the
study duration
Exclusion Criteria:
1. History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic
colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (ie,
colitis not consistent with CD), radiation colitis, microscopic colitis, colonic
mucosal dysplasia, or untreated bile acid malabsorption.
2. CD-related complications (previous extensive small bowel resection, ileorectal
anastomosis, proctocolectomy, short bowel syndrome, ileostomy [diverting or end],
colostomy, small bowel stoma, ileoanal pouch, inactive fistulae in or adjacent to an
ileal stricture, colonic stricture, anal and perianal stricture, active intra-abdominal
or perianal abscess that has not been appropriately treated, abscess in relation to
the stricture, toxic megacolon, very severe inflammation, or presence of deep
ulceration in the colon or terminal ileum).
3. Ileitis not associated with CD (e.g., ileitis associated with infections,
spondyloarthropathies, ischemia, etc.).
4. Endoscopic balloon dilation or surgical treatment of the same small bowel stricture
within the last 6 months prior to screening.
5. Receiving cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks
of screening or Janus kinase inhibitor therapy within 4 weeks of screening.
6. Requiring continued treatment with systemically administered medications that are
sensitive CYP3A4/5 substrates with a narrow therapeutic index or strong inhibitors of
aldehyde oxidase or xanthine oxidase.
7. Current or history of vasculitis, valvulopathy or large vessel disorder or major
abnormalities documented by cardiac echocardiography with Doppler.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.