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Efficacy and Safety of Afimetoran Compared with Placebo in Participants with Active Systemic Lupus Erythematosus
EU CTIS ID: 2023-504320-25-00
What this study is testing
To assess the efficacy of Afimetoran versus placebo using a composite measure of improvement in lupus activity that is primarily driven by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in participants with active SLE
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosed ≥ 12 weeks before the screening visit and qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
- Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody
- Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash
- Inclusion criteria for long-term extension (LTE) period: - Completion of study treatment through Week 48 - In the opinion of the investigator, participant may benefit from continuation in the optional LTE period
You likely can't join if
- Active severe lupus nephritis (LN) as assessed by the investigator
- Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
- Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- Antiphospholipid Syndrome
- Exclusion criteria for long-term extension (LTE) period: - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric) or active infection/infectious illness that, as determined by the investigator's clinical judgment, will substantially increase the risk to the participant if he or she participates in the LTE
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Taiwan
- Argentina
- Japan
- Australia
- United States
- Mexico
- Brazil
- Colombia
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Taiwan; Argentina; Japan; Australia; United States and 4 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 EU CTIS; the study team decides eligibility.