BridgeMD
Efficacy and safety of Frexalimab (SAR441344) in the treatment of Systemic Lupus Erythematosus
EU CTIS ID: 2023-508654-26-00
What this study is testing
To evaluate the efficacy of SAR441344 in comparison with placebo and in addition to standard of care (SOC), over a 24-week period, on disease activity 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
- Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria
- Positive ANA (titer ≥1:80) during screening
- Positivity for at least one serological characteristic
- Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s)
- At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
- Receiving at least one of the SOC for SLE (combination is possible)
You likely can't join if
- Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
- High dose of steroids, or a change in dose within 4 weeks prior to randomization
- High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
- High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
- Use of cyclophosphamide within 3 months prior to screening
- Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
See the full eligibility criteria
- Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria
- Positive ANA (titer ≥1:80) during screening
- Positivity for at least one serological characteristic
- Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s)
- At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
- Receiving at least one of the SOC for SLE (combination is possible)
- Body weight within 45 kg to 120 kg (inclusive) at screening
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
- High dose of steroids, or a change in dose within 4 weeks prior to randomization
- High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
- High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
- Use of cyclophosphamide within 3 months prior to screening
- Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
- Participants likely to require multiple courses of OCS during the study for chronic diseases other than SLE
- Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
- Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization
- Active and severe lupus nephritis
- Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
- Known or suspected drug-induced lupus
- History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment
- History or current hypogammaglobulinemia
- Serious systemic viral, bacterial or fungal infection
- Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution
- Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest X-rays) and examination, and tuberculosis testing
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Mexico
- Argentina
- Brazil
- Ukraine
- Turkey
- United States
- Georgia
- Switzerland
- Russian Federation
- Mauritius
- Puerto Rico
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Mexico; Argentina; Brazil; Ukraine; Turkey and 6 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.