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:
- Have Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or
ileocolitis, confirmed at any time in the past by endoscopy and histology
- Must have moderately to severely active Crohn's disease (as defined by a baseline
Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [>] 30); have
ileocolonoscopy with evidence of active Crohn's disease defined as presence of
ulceration (which is equal to Simple Endoscopic Score for Crohn's disease [SES-CD]
score greater than or equals to [>=] 3) during screening into this study. The
ileocolonoscopy procedure must occur within approximately 3 weeks prior to the
administration of study intervention at Week 0 (Induction Period). A video
ileocolonoscopy recorded within 3 months prior to the Week 0 (Induction Period) visit
may be used in case of rescreening of a participant who had an ileocolonoscopy but
failed the initial screening for another reason, on a case-by-case basis, after
consultation with the sponsor. If unable to evaluate ulceration due to stricture or
inadequate bowel preparation, at least one of the following criteria may instead be
applied: an abnormal C-reactive protein (CRP) (> 0.3 milligram per deciliter [mg/dL]
or 3.0 milligram per liter [mg/L] at screening) or; fecal calprotectin of >= 250
milligram per kilogram [mg/kg] or >= 250 microgram per gram [mcg/g] at screening
- If receiving enteral nutrition, must have been on a stable regimen for at least 2
weeks prior to induction week 0 (Week I-0)
- Females of childbearing potential must have a negative highly sensitive urine
pregnancy test at screening and at Week I-0 prior to study intervention administration
Exclusion Criteria:
- Has complications of Crohn's disease such as symptomatic strictures or stenosis, short
gut syndrome, or any other manifestation that might be anticipated to require surgery,
that could preclude the use of the PCDAI to assess response to therapy or would
possibly confound the ability to assess the effect of treatment with ustekinumab
- Have a history of latent or active granulomatous infection, histoplasmosis, or
coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to
screening
- Presence or history of any malignancy including presence or history of
lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of
possible lymphoproliferative disease, such as lymphadenopathy of unusual size or
location (example, nodes in the posterior triangle of the neck, infraclavicular,
epitrochlear, or periaortic areas), and monoclonal gammopathy of undetermined
significance, or clinically significant hepatomegaly or splenomegaly
- Have a history of moderate or severe progressive or uncontrolled liver or renal
insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal,
endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic
disturbances
- Received an investigational intervention including any investigational vaccines or
used an invasive investigational medical device within 3 months before the planned
first dose of study intervention or is currently enrolled in an investigational study;
receipt of an investigational vaccine for Coronavirus Disease 2019 (COVID-19) is not
an automatic exclusion criterion
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.