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APATURA Trial Summary
This trial is studying a new drug for Lupus to see if it is effective and safe.
APATURA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPATURA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APATURA Trial Design
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Who is running the clinical trial?
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- I have had serious infections like histoplasmosis or candidiasis.I do not have active or untreated latent tuberculosis.I do not have a serious infection.I have severe or unstable mental health issues due to lupus.I am currently on a standard treatment for lupus.I may need several steroid treatments for a chronic condition other than lupus.I haven't had a non-live vaccine like flu or COVID-19 shot in the last 4 weeks.I haven't had steroid injections or IVs in the last 4 weeks.I haven't taken high doses of steroids or changed my dose in the last 4 weeks.I haven't taken high doses of immunosuppressants or changed my dose in the last 3 months.I have been diagnosed with lupus for at least 6 months.My weight is between 45 kg and 120 kg.I have severe kidney inflammation due to lupus.I have a history of or currently have low levels of antibodies.I have not used cyclophosphamide in the last 3 months.I have a rheumatic condition that is not lupus.I have not received any live vaccines in the last 3 months.My lupus severity score is 6 or more, with symptoms including arthritis and rash.I have a history or risk of blood clots, heart attack, stroke, or antiphospholipid syndrome.I have not changed or started a high dose of antimalarial medication in the last 3 months.
- Group 1: SAR441344
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this investigation actively seeking participants at the moment?
"Confirmed. According to information on clinicaltrials.gov, the search for participants is still ongoing and this trial has been active since November 10th 2021; with updates occurring up until September 5th 2022. The study requires 116 people across a total of 10 designated sites."
Who is eligible to join this clinical trial?
"The current trial is seeking 116 individuals with Libman-Sacks disease aged between 18 and 70 to participate. To be eligible, applicants should have a diagnosis of SLE that meets the Revised Criteria for Classification (1997 Update), test positive for antinuclear antibodies, total hSELENA-SLEDAI score ≥6, at least 1 BILAG A or 2 BILAG B scores during screening period; be taking one of the SOCs for SLE therapy along with contraceptive use in accordance to local regulations. Additionally they must weigh between 45 kg and 120kg inclusive."
Does this research accept individuals aged 65 and over as participants?
"To be eligible for this trial, participants must fall between the ages of 18 and 70. If a patient is younger than 18, they can enrol in one of the other 18 trials available whereas those over 65 may wish to consider one of the 104 options that apply to them."
How many sites are currently executing this experiment?
"This investigation is taking place at the Omega Research Centre in DeBary, Florida (Site Number: 8400002), Prolato Clinical Research Center in Houston, Texas (Site Number: 84005), and Ramesh C. Gupta, M.D.in Memphis Tennessee(Site Number:840008) as well as 10 additional sites across the country."
Could you elucidate the security of SAR441344 SC for human individuals?
"Our team at Power scored SAR441344 SC with a 2 on the safety scale since, as it is in Phase 2 of trials, there are some data that corroborate its security but none to validate its efficacy."
What is the cap for participant recruitment in this trial?
"A total of 116 eligible patients must be recruited for the trial. Omega Research-Site Number:8400002 in DeBary, Florida and Prolato Clinical Research Center-Site Number:8400005 in Houston, Texas are among the locations where recruitment is taking place."
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