Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541589
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2020-08-14
Brief Title:
Study of Safety and Tolerability of CFZ533 in Patients With Sjögrens Syndrome
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 Iscalimab at Two Dose Levels Administered Subcutaneously in Patients With Sjögrens Syndrome
Status:
COMPLETED
Status Verified Date:
2024-09
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:
TWINSS Extn
Brief Summary:
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögrens Syndrome who participated in the TWINSS core study CCFZ533B2201NCT03905525 Additionally this Extension study will further explore the pharmacokinetics PK and efficacy of iscalimab at two dose level
Detailed Description:
This Extension study is a 48-week treatment study with a safety follow-up period of 12 weeks This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögrens Syndrome who must have participated in the TWINSS core study CCFZ533B2201 NCT03905525 and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60
Study treatment will be administered as bi-weekly subcutaneous injections Q2W sc via prefilled syringes PFS
Study treatment will be administered as bi-weekly subcutaneous injections Q2W sc via prefilled syringes PFS
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 |
|---|---|---|---|
| 2020-001942-20 | EUDRACT_NUMBER | None | None |