Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130540
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-11-08
Brief Title:
Study to Evaluate the Pharmacokinetics Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multicenter Study to Evaluate the Pharmacokinetics Safety and Tolerability of Intravenous Secukinumab Infusion in Adults With Giant Cell Arteritis GCA or Polymyalgia Rheumatica PMR
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:
None
Brief Summary:
This study will examine how intravenous iv Secukinumab will be processed in the body pharmacokinetics PK and whether it will be safe and tolerable after multiple doses of iv Secukinumab infusion in adult patients with giant cell arteritis GCA or polymyalgia rheumatica PMR
Detailed Description:
This is a 12-week open-label multicenter basket design study followed by an 8-week follow-up period in two cohorts of participants one cohort with GCA and one cohort with PMR
This study will consist of 3 phases screening treatment and follow-up
Participants will enter a screening period up to 6 weeks to assess eligibility or up to 8 weeks in the event of a major healthcare disruption or a need to complete screening requirements eg required washouts TB testing and work up and treatment as needed per local guidelines Participants will enter a treatment period of 12 weeks 2 cohorts GCA and PMR cohorts receiving total of 3 iv doses of Secukinumab Week 0 Week 4 and Week 8 After treatment participants will enter a follow-up period 8 weeks treatment-free follow-up 12 weeks after last dose of study treatment
The total duration of the trial for a participant from screening to follow up is approximately 26 weeks maximum of approximately 28 weeks including safety follow-up
This study will consist of 3 phases screening treatment and follow-up
Participants will enter a screening period up to 6 weeks to assess eligibility or up to 8 weeks in the event of a major healthcare disruption or a need to complete screening requirements eg required washouts TB testing and work up and treatment as needed per local guidelines Participants will enter a treatment period of 12 weeks 2 cohorts GCA and PMR cohorts receiving total of 3 iv doses of Secukinumab Week 0 Week 4 and Week 8 After treatment participants will enter a follow-up period 8 weeks treatment-free follow-up 12 weeks after last dose of study treatment
The total duration of the trial for a participant from screening to follow up is approximately 26 weeks maximum of approximately 28 weeks including safety follow-up
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 |
|---|---|---|---|
| 2023-507667-19-00 | OTHER | EU CT number | None |