Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04961567
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2021-07-05
Brief Title:
A Study to Learn About the Safety of Litifilimab BIIB059 Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Status:
RECRUITING
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:
TOPAZ-2
Brief Summary:
In this study researchers will learn more about a study drug called litifilimab BIIB059 in participants with systemic lupus erythematosus SLE The study will focus on participants who have active disease and are already taking standard of care medications These may include antimalarials steroids and immunosuppressants
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease The main question researchers want to answer is
- How many participants have an improvement in their symptoms after 52 weeks of treatment Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools These include the SLE Responder Index SRI the Systemic Lupus Erythematosus Disease Activity Index-2000 SLEDAI-2K and the Patient Global Assessment - Visual Analog Scale PGA-VAS
Researchers will also learn more about the safety of litifilimab They will study how participants immune systems respond to litifilimab Additionally they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires
The study will be done as follows
After screening participants will be randomized to receive either a high or low dose of litifilimab or placebo A placebo looks like the study drug but contains no real medicine
All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks The treatment period will last 52 weeks Participants will continue to take their standard of care medications
Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo
There will be a follow-up safety period that lasts up to 24 weeks
In total participants will have up to 22 study visits The total study duration for participants will be up to 80 weeks
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease The main question researchers want to answer is
- How many participants have an improvement in their symptoms after 52 weeks of treatment Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools These include the SLE Responder Index SRI the Systemic Lupus Erythematosus Disease Activity Index-2000 SLEDAI-2K and the Patient Global Assessment - Visual Analog Scale PGA-VAS
Researchers will also learn more about the safety of litifilimab They will study how participants immune systems respond to litifilimab Additionally they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires
The study will be done as follows
After screening participants will be randomized to receive either a high or low dose of litifilimab or placebo A placebo looks like the study drug but contains no real medicine
All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks The treatment period will last 52 weeks Participants will continue to take their standard of care medications
Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo
There will be a follow-up safety period that lasts up to 24 weeks
In total participants will have up to 22 study visits The total study duration for participants will be up to 80 weeks
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-505696-74 | OTHER | EU CTIS | None |