Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03905525
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2019-03-25
Brief Title:
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogrens Syndrome
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 48-week 6-arm Randomized Double-blind Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogrens Syndrome TWINSS
Status:
COMPLETED
Status Verified Date:
2023-09
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
Brief Summary:
This study will evaluate safety efficacy pharmacokinetics PK and pharmacodynamics PD of multiple doses of CFZ533 iscalimab in patients with Sjögrens Syndrome
Detailed Description:
This is a double-blind randomized placebo-controlled multicenter study of CFZ533 in 2 distinct populations cohorts of patients with Sjögrens Syndrome 1 moderate-to-severe disease systemic and symptomatic involvement and 2 low systemic involvement but high symptom burden
The study includes up to 6 weeks screening period 48 weeks of treatment divided into treatment periods of 24 weeks each and 12 weeks follow up Study treatment will be administered as bi-weekly subcutaneous injections
The study includes up to 6 weeks screening period 48 weeks of treatment divided into treatment periods of 24 weeks each and 12 weeks follow up Study treatment will be administered as bi-weekly subcutaneous injections
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 |
|---|---|---|---|
| 2018-004476-35 | EUDRACT_NUMBER | None | None |