A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 5 May 2025
• Main ID: NCT04673357
• Date of registration: 14/12/2020
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease UNITI Jr
• Scientific title: A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: April 6, 2021
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04673357
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Belgium, Germany, Hungary, Israel, Japan, Poland, Russian Federation, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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


Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Placebo

Drug: Ustekinumab

Primary Outcome(s)

Number of Participants with Clinical Remission at Maintenance Week 44 [Time Frame: Week 44 (Maintenance Period)]

Number of Participants with Reactions Temporally Associated with Intravenous (IV) Infusion (Induction Period) [Time Frame: Up to Week 8 (Induction period)]

Number of Participants with Subcutaneous (SC) Injection-Site Reactions (Maintenance Period) [Time Frame: Up to Week 44 (Maintenance period)]

Number of Participants with Abnormalities in Clinical Laboratory Parameters [Time Frame: Up to Week 52]

Number of Participants with Adverse Events (AEs) [Time Frame: Up to Week 74]

Number of Participants with AEs leading to Discontinuation of Study Intervention [Time Frame: Up to Week 74]

Number of Participants with Clinical Remission at Induction Week 8 [Time Frame: Week 8]

Number of Participants with Serious Adverse Events (SAEs) [Time Frame: Up to Week 74]

Number of Participants with AEs of Interest [Time Frame: Up to Week 74]

Serum Ustekinumab Concentrations [Time Frame: Up to Week 52]

Secondary Outcome(s)

Number of Participants with Clinical Response [Time Frame: Week 8 (Maintenance period)]

Number of Participants with Corticosteroid-free Clinical Remission [Time Frame: Week 44 (Maintenance period)]

Number of Participants with Endoscopic Response as Assessed by Simplified Endoscopic Score-Crohn's Disease (SES-CD) [Time Frame: Week 8 (Maintenance period)]

Number of Participants with Endoscopic Response as Assessed by SES-CD [Time Frame: Week 44 (Maintenance period)]

Number of Participants with Clinical Remission at Week 44 (Maintenance Period) who are in Clinical Remission at Week 8 (Induction Period) [Time Frame: Week 44 (Maintenance Period)]

Number of Participants with Clinical Response [Time Frame: Week 8 (Induction period)]

Number of Participants with Clinical Remission [Time Frame: Week 44 (Maintenance period)]

Number of Participants with Clinical Remission as Assessed by short Pediatric Crohn's Disease Activity Index (sPCDAI) [Time Frame: Week 6 (Induction period)]

Number of Participants with Clinical Response [Time Frame: Week 44 (Maintenance period)]

Number of Participants with Clinical Response as Assessed by sPCDAI [Time Frame: Week 6 (Induction period)]

Secondary ID(s)

2019-004225-24

2023-504978-38-00

CNTO1275CRD3004

CR108864

Source(s) of Monetary Support

Please refer to primary and secondary sponsors