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. Has moderately to severely active UC, unresponsive or intolerant to their current
standard of care (SOC).
2. Weighs ≥10 kg at the time of screening and enrollment into the study.
3. Participants with UC diagnosed at least 1 month before screening. Participants with
moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo
endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a
Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an
endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the
following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP],
methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-?)
antagonist therapy (eg, infliximab, adalimumab). This includes participants who are
dependent on corticosteroids to control symptoms and who are experiencing worsening of
disease in the moderate-to-severe range when attempting to wean off corticosteroids.
5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis),
at a minimum.
6. Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12
years' duration must have documented evidence of a negative surveillance colonoscopy
within 12 months before screening.
7. Participants with vaccinations that are up-to-date based on the countrywide, accepted
schedule of childhood vaccines.
Exclusion Criteria:
1. Has previous exposure to approved or investigational anti-integrins including, but not
limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal
addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
2. Has received an investigational biologic within 60 days or 5 half-lives before
screening (whichever is longer); or an approved biologic or biosimilar agent within 2
weeks before the first dose of study drug or at any time during the screening period.
3. Has active cerebral/meningeal disease, signs/symptoms or history of progressive
multifocal leukoencephalopathy (PML) or any other major neurological disorders
including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus
disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
5. Has received any live vaccinations within 30 days prior to first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require
surgical intervention for UC during this study.
7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy,
ileo-anal pouch, or known fixed stenosis of the intestine.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early onset inflammatory
bowel disease.
10. Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB
test performed within 30 days of screening or during the screening period that is
positive, defined as:
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- A TB skin test reaction ≥5 mm. NOTE: If participants have received Bacillus
Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed
instead of the TB skin test.
11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie,
hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may,
however, be included. Note: If a participant tests negative for HBsAg, but positive
for HBcAb, the participant would be considered eligible if the absence of HBV DNA is
confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central
laboratory.
Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb]
and HCV RNA). Note: Subjects who are HCVAb-positive without evidence of HCV RNA may be
considered eligible (spontaneous viral clearance or previously treated and cured
[defined as no evidence of HCV RNA at least 12 weeks before baseline]).
12. The participant has evidence of dysplasia or history of malignancy other than a
successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or
localized carcinoma in situ of the cervix.
13. Has positive stool studies for ova and/or parasites or stool culture at screening
visit.
14. Has positive Clostridioides difficile (C difficile) stool test at screening visit.
Other inclusion/exclusion criteria may apply.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/27/2024. Questions regarding updates should be directed to the study team contact.