Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781816
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2021-02-28
Brief Title:
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Double-blind Placebo Controlled Proof of Concept Study Assessing the Efficacy and Safety of the RIPK1-inhibitor SAR443122 in Patients With Moderate to Severe Subacute or DiscoidChronic Cutaneous Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2024-06
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:
CLEan
Brief Summary:
Primary Objective
Assess the efficacy of SAR443122 in cutaneous lupus erythematosus CLE
Secondary Objectives
Assess the effect of SAR443122 on the physicians global assessment of disease activity PhysGA - disease activity
Assess the effect of SAR443122 on CLE induced itch and overall pain
Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo
Assess the effect of SAR443122 on the CLASI components score
Assess the effect of SAR443122 on the Investigators global assessment for CLE IGA-CLE
Assess oral cavities for patients with oral lesions
Assess the disease specific quality of life QoL
Assess the safety and tolerability of SAR443122 in patients with CLE
Assess the pharmacokinetics PK exposure of SAR443122 in patients with CLE
Assess the efficacy of SAR443122 in cutaneous lupus erythematosus CLE
Secondary Objectives
Assess the effect of SAR443122 on the physicians global assessment of disease activity PhysGA - disease activity
Assess the effect of SAR443122 on CLE induced itch and overall pain
Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo
Assess the effect of SAR443122 on the CLASI components score
Assess the effect of SAR443122 on the Investigators global assessment for CLE IGA-CLE
Assess oral cavities for patients with oral lesions
Assess the disease specific quality of life QoL
Assess the safety and tolerability of SAR443122 in patients with CLE
Assess the pharmacokinetics PK exposure of SAR443122 in patients with CLE
Detailed Description:
Total study duration per participant was up 20 weeks including
A screening period of up to 4 weeks
A treatment period of 12 weeks
A post treatment follow-up period of 4 weeks
A screening period of up to 4 weeks
A treatment period of 12 weeks
A post treatment follow-up period of 4 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004703-14 | EUDRACT_NUMBER | ICTRP | None |
| U1111-1246-6784 | REGISTRY | None | None |