Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
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: - Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator - Must have had UC diagnosed prior to screening - Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy - A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for>= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention orb) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention - 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: 100 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: - Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon - Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy) - 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 - Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients 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 active UC. 2. To evaluate the safety profile of ustekinumab in pediatric participants with moderately to severely active UC. 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 Week I-8. US-specific 2. Clinical remission at 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 response at Week I-8. 2. Symptomatic remission at Week I-8. 3. Clinical remission at Week I-8 as assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) score. 4. Endoscopic improvement at Week I-8. 5. Clinical remission at Maintenance Week (Week M-44.) 6. Histologic-endoscopic mucosal improvement at Week I-8. 7. Clinical remission at Week M-44. 8. Symptomatic remission at Week M-44. 9. Clinical remission at Week M-44 as assessed by the PUCAI score. 10. Endoscopic improvement at Week M-44. 11. Corticosteroid-free clinical remission at Week M-44. 12. Clinical remission at Week M-44 and not receiving corticosteroids for at least 90 days prior to Week M-44 among participants who received corticosteroids at Week I-0. 13. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8. 14. Histologic-endoscopic mucosal improvement at Week M-44. US-specific 15. Clinical remission at Week I-8. 16. Clinical response at Week I-8. 17. Symptomatic remission at Week I-8. 18. Clinical remission at Week I-8 as assessed by the PUCAI score. 19. Endoscopic improvement at Week I-8. 20. Histologic-endoscopic mucosal improvement at Week I-8. 21. Symptomatic remission at Week M-44. 22. Clinical remission at Week M-44 as assessed by the PUCAI score. 23. Endoscopic improvement at Week M-44. 24. Corticosteroid-free clinical remission at Week M-44. 25. Clinical remission at Week M-44 and not receiving corticosteroids for at least 90 days prior to Week M-44 among participants who received corticosteroids at Week I-0. 26. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8. 27. Histologic-endoscopic mucosal improvement at Week M-44.;Timepoint(s) of evaluation of this end point: 1 to 4. and 11 to 15. Week I-8 5 to 10. and 16 to 20. Week M-44 | — |
Countries
Belgium, Germany, Hungary, Japan, Poland, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International N.V.
Outcome results
None listed