Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02472795
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2015-05-14
Brief Title:
Clinical Study to Investigate the Biological Activity Safety Tolerability and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Dose-response Study to Investigate the Biological Activity Safety Tolerability and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2020-02
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:
International trial to evaluate the biological activity and safety of cenerimod ACT-334441 in systemic lupus erythematosus SLE patients
Detailed Description:
This multicentre double-blind placebo-controlled study will have a staggered approach Part A and B
In part A eligible patients will be randomly assigned 1111 to once daily oral administration of cenerimod 05 1 2 mg or placebo After all patients have completed 4 weeks of treatment during part A an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B
In part B additional patients will be randomized 31 to once daily oral administration of cenerimod 4 mg or placebo
All participants will receive study medication for 12 weeks
In part A eligible patients will be randomly assigned 1111 to once daily oral administration of cenerimod 05 1 2 mg or placebo After all patients have completed 4 weeks of treatment during part A an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B
In part B additional patients will be randomized 31 to once daily oral administration of cenerimod 4 mg or placebo
All participants will receive study medication for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None