Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655807
Status:
WITHDRAWN
Last Update Posted:
2021-09-01
First Post:
2020-11-30
Brief Title:
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohns Disease
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 2a Randomized Double-blind Placebo-controlled Parallel-group Multicenter Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 1223 in Responder Not Remitter Participants With Active Crohns Disease
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUET
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care SOC biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 1223 inhibitors in participants with active Crohns disease in response but not remission to SOC biologic therapy
Detailed Description:
Biologic agents such as anti-tumor necrosis factor TNF and interleukin IL-1223 antagonists have become the standard of care SOC in the treatment of patients with Crohns disease However many patients fail to fully respond to treatment This study will evaluate the efficacy of 10 week add on treatment with JNJ-64304500 compared to placebo in patients taking SOC anti-TNF or anti-IL1223 biologics The study consists of a screening phase up to 8 weeks treatment phase up to 12 weeks and follow-up phase up to 16 weeks after the last administration of study agent The total study duration will be up to 34 weeks Key safety assessments include adverse events clinical laboratory tests hematology and chemistry vital signs monitoring for injection-site and hypersensitivity reactions and early detection of active tuberculosis
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 |
|---|---|---|---|
| 64304500CRD2002 | OTHER | Janssen Research Development LLC | None |
| 2020-002701-26 | EUDRACT_NUMBER | None | None |