Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559163
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study of Obexelimab in Patients with Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SunStone
Brief Summary:
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus SLE
Detailed Description:
This study consists of a 24-week treatment period followed by a 12-week follow-up period Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism EULARAmerican College of Rheumatology ACR Classification Criteria To enter the Screening Period Day -28 to Day -1 patients will have active SLE as defined by having a hybrid Systemic Lupus Erythematosus Disease Activity Index hSLEDAI 6 and clinical hSLEDAI 4 and b British Isles Lupus Assessment Group BILAG-2004 Grade A or B in 1 organ system Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies oral corticosteroid antimalarial andor immunosuppressant
On Day 1 patients will be randomized 11 to obexelimab or placebo subcutaneous SC injection once per week QW for 24 weeks All patients will return to the study site for scheduled visits at Week 2 Week 4 and then every 4 weeks thereafter until study completion During the study patients will undergo assessments for efficacy safety PK PD and immunogenicity
Including screening and follow-up the maximum duration of participation in this study for an individual patient is approximately 40 weeks ie up to a 28-day Screening Period 24-week Treatment Period and a 12-week follow-up
On Day 1 patients will be randomized 11 to obexelimab or placebo subcutaneous SC injection once per week QW for 24 weeks All patients will return to the study site for scheduled visits at Week 2 Week 4 and then every 4 weeks thereafter until study completion During the study patients will undergo assessments for efficacy safety PK PD and immunogenicity
Including screening and follow-up the maximum duration of participation in this study for an individual patient is approximately 40 weeks ie up to a 28-day Screening Period 24-week Treatment Period and a 12-week follow-up
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