Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633447
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2020-11-06
Brief Title:
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Placebo-controlled Double-blind Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study primary endpoint was not met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THEIA
Brief Summary:
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo in combination with a 26-week glucocorticoid GC taper regimen in adult participants with new-onset or relapsing giant cell arteritis GCA
Detailed Description:
Giant cell arteritis GCA is a non-necrotizing granulomatous systemic vasculitis of unknown etiology affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation Guselkumab is a monoclonal antibody mAb that binds to the p19 sub-unit of human interleukin IL-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production It is used in treatment of psoriatic arthritis generalized pustular psoriasis erythrodermic psoriasis The study consists of a screening period less than or equal to 6 weeks double-blind treatment period 48 weeks and safety follow-up period 12 weeks Participants who complete the Week 52 visit and are assessed to be in glucocorticoid GC-free remission may have the option to participate in the long-term extension LTE period of the study for up to 12 months This study will evaluate the efficacy safety Pharmacokinetics PK and immunogenicity of guselkumab in combination with a 26-week GC taper regimen for the treatment of active new-onset or relapsing GCA in adult participants The total duration of the study is up to 66 weeks for the main study and for participants that continue in the LTE period the total study duration will be up to 112 weeks
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 |
|---|---|---|---|
| 2020-000622-26 | EUDRACT_NUMBER | None | None |
| CNTO1959GCA2001 | OTHER | Janssen Research Development LLC | None |