Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04929210
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-06-11
Brief Title:
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 4 Multicenter Randomized Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
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:
STAR
Brief Summary:
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis PsA axial disease by assessing reduction in axial symptoms and inflammation
Detailed Description:
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains and axial disease represents one of the domains Guselkumab is a fully human immunoglobulin Ig G1 lambda monoclonal antibody mAb that by binding to the p19 protein subunit of interleukin IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor inhibiting IL-23-mediated intracellular signaling activation and cytokine production This study will consist of a screening phase up to 6 weeks a treatment phase up to 48 weeks including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48 and a safety follow-up phase up to Week 60 The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index BASDAI score and the safety assessments will include evaluations of physical examinations vital signs electrocardiograms clinical laboratory tests and adverse events The overall duration of the study will be up to 14 months
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 |
|---|---|---|---|
| 2021-000465-32 | EUDRACT_NUMBER | None | None |
| CNTO1959PSA4002 | OTHER | Janssen Research Development LLC | None |