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New treatment option for Systemic Lupus Erythematosus
Official title A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06559163
What this study is testing
What is Obexelimab?
Obexelimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Males and females, ≥ 18 to ≤ 70 years of age
- Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
- Patient has all 3 of the following based on features active on the day of the visits:
- hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except...
- BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
You likely can't join if
- Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's...
- A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid...
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not...
- Active severe neuropsychiatric or central nervous system SLE.
- Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive...
See the full eligibility criteria
- Males and females, ≥ 18 to ≤ 70 years of age
- Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
- Patient has all 3 of the following based on features active on the day of the visits:
- hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
- BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
- In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
- Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
- Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is...
- A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
- Active severe neuropsychiatric or central nervous system SLE.
- Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Huntington Park, California, United States
- La Jolla, California, United States
- Clearwater, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Lake Charles, Louisiana, United States
- Detroit, Michigan, United States
- Lansing, Michigan, United States
- Charlotte, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
- Mansfield, Texas, United States
- Liège, Belgium
- Haskovo, Bulgaria
- Plovdiv, Bulgaria
- Richmond, British Columbia, Canada
- Sydney, Nova Scotia, Canada
- Hefei, Anhui, China
+ 51 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Huntington Park, California, United States; La Jolla, California, United States; Clearwater, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 65 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.