Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470048
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Placebo-controlled Multicenter Study to Evaluate Efficacy Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
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:
The purpose of this study is to evaluate efficacy safety and tolerability of sc ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Detailed Description:
The study consists of the following periods
Screening Period with a duration of up to 6 weeks
Treatment Period 1 with a duration of 52 weeks
Treatment Period 2 Open-label treatment with a duration of 52 weeks
Post-treatment Follow-up Period with a duration of at least 20 weeks post last dose and up to 2 years
Screening Period with a duration of up to 6 weeks
Treatment Period 1 with a duration of 52 weeks
Treatment Period 2 Open-label treatment with a duration of 52 weeks
Post-treatment Follow-up Period with a duration of at least 20 weeks post last dose and up to 2 years
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 |
|---|---|---|---|
| 2024-511933-36-00 | REGISTRY | None | None |