Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT02472795
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Sponsor:
Viatris Innovation GmbH
Organization:
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 (1:1:1:1) to once daily oral administration of cenerimod (0.5, 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 (3:1) 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 (1:1:1:1) to once daily oral administration of cenerimod (0.5, 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 (3:1) 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:
True
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?: