Moderately to Severely Active Crohn's Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: - 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 1-0 prior to study intervention administration Please refer to protocol for all the inclusion criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: - 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 Please refer to protocol for all the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Global: 1. To evaluate the efficacy of ustekinumab dosing in inducing clinical remission in pediatric participants with moderately to severely Crohn's disease 2. To evaluate the safety profile of ustekinumab in pediatric participants with moderately to severely active Crohn's disease. 3. To evaluate ustekinumab exposure (PK). US specific: 4. To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction. 5. To evaluate the safety profile of ustekinumab. 6. To evaluate ustekinumab exposure (pharmacokinetics [PK]).;Secondary Objective: 1. To evaluate the efficacy of IV ustekinumab during the induction period. 2. To evaluate the efficacy of SC ustekinumab during the maintenance period among participants who were in clinical response in induction.;Primary end point(s): Global 1. Clinical remission at Induction Week 8 (Week I-8). US-specific 2. Clinical remission at Maintenance Week (Week M-44).;Timepoint(s) of evaluation of this end point: 1. Week I-8 2. Week M-44 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: Global 1. Clinical remission at Week I-6 as assessed by sPCDAI 2. Clinical response at Week I-8 3. Clinical response at Week I-6 as assessed by sPCDAI 4. Endoscopic response at Maintenance Week 8 (Week M-8) as assessed by SES-CD 5. Clinical response at Week M-8 The following endpoints will be evaluated for participants who are clinical responders at Week I-8: 6. Clinical remission at Week M-44 7. Endoscopic response at Week M-44 as assessed by SES-CD 8. Clinical response at Week M-44 9. Corticosteriod-free clinical remission at Week M-44 10. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8 US-specific 11. Clinical Remission at Week I-8 12. Clinical Remission at Week I-6 as assessed by sPCDAI 13. Clinical Response at Week I-8 14. Clinical response at Week I-6 as assessed by sPCDAI 15. Endoscopic response at Week M-8 as assessed by SES-CD 16. Clinical response at Week M-8 The following endpoints will be evaluated for participants who are clinical responders at Week I-8: 17. Endoscopic response at Week M-44 as assessed by SES-CD 18. Clinical response at Week M-44 19. Corticosteroid-free clinical remission at Week M-44 20. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8;Timepoint(s) of evaluation of this end point: 1, 3, 13 and 15 Week I-6 2, 12 and 14 Week I-8 4, 5, 16 and 17 Week M-8 6 - 11 and 18 - 22 Week M-44 | — |
Countries
Belgium, Germany, Hungary, Japan, Poland, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International NV
Outcome results
None listed