Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475742
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-28
First Post:
2024-06-20
Brief Title:
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Single-arm Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus SLE on Top of Background Therapy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
OPUS OLE
Brief Summary:
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus
The main questions it aims to answer are
Whether cenerimod causes any adverse effects side effects when given on top of drugs already being given for systemic lupus erythematosus
How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years
Participants taking part in this study will have already taken part in another study where they received either cenerimod or placebo look-alike substance containing no active drug for 1 year
In this clinical study approximately 680 participants will receive cenerimod on top of drugs already being given for systemic lupus erythematosus for at least 1 year and up to 3 years
The main questions it aims to answer are
Whether cenerimod causes any adverse effects side effects when given on top of drugs already being given for systemic lupus erythematosus
How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years
Participants taking part in this study will have already taken part in another study where they received either cenerimod or placebo look-alike substance containing no active drug for 1 year
In this clinical study approximately 680 participants will receive cenerimod on top of drugs already being given for systemic lupus erythematosus for at least 1 year and up to 3 years
Detailed Description:
Participants who completed the 12-month double-blind treatment period cenerimod 4 mg or placebo in either of the parent studies ID-064A301 or ID-064A302 are eligible to participate in this extension study
All participants in this study will receive cenerimod 4 mg for at least 12 months 1 year and up to a maximum of 36 months 3 years All participants may additionally receive standard of care treatment for systemic lupus erythematosus ie at least 1 of the following oral corticosteroids antimalarial drugs or immunosuppressant drugs
When all participants have reached at least 12 months of study treatment or have prematurely discontinued study treatment before the end of Month 12 the end-of-treatment will be scheduled for all participants who are still on study treatment
The safety follow-up period starts on the day after the last dose of study treatment and ends after 6 months with the final study visit Thus the maximum duration of participation is 35 years
Data collected in this extension study will allow an assessment of whether the safety and tolerability profile of cenerimod established in the controlled parent studies remains the same after a longer period of treatment
All participants in this study will receive cenerimod 4 mg for at least 12 months 1 year and up to a maximum of 36 months 3 years All participants may additionally receive standard of care treatment for systemic lupus erythematosus ie at least 1 of the following oral corticosteroids antimalarial drugs or immunosuppressant drugs
When all participants have reached at least 12 months of study treatment or have prematurely discontinued study treatment before the end of Month 12 the end-of-treatment will be scheduled for all participants who are still on study treatment
The safety follow-up period starts on the day after the last dose of study treatment and ends after 6 months with the final study visit Thus the maximum duration of participation is 35 years
Data collected in this extension study will allow an assessment of whether the safety and tolerability profile of cenerimod established in the controlled parent studies remains the same after a longer period of treatment
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 |
|---|---|---|---|
| 2024-514354-67 | EUDRACT_NUMBER | None | None |