Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260163
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-02-07
Brief Title:
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Induction Double-blind Maintenance Parallel-group Multicenter Protocol to Evaluate the Efficacy Safety and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUASAR Jr
Brief Summary:
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502238-22-00 | REGISTRY | EUCT number | None |
| 2022-001285-35 | EUDRACT_NUMBER | None | None |
| CNTO1959PUC3001 | OTHER | None | None |