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SAR441344 for Lupus (APATURA Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Body weight within 45 kg to 120 kg (inclusive) at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until week 36

Awards & highlights

APATURA Trial Summary

This trial is studying a new drug for Lupus to see if it is effective and safe.

Who is the study for?

Adults aged 18-70 with active Systemic Lupus Erythematosus (SLE) can join this trial. They must have been diagnosed at least 6 months ago, be on standard SLE care, and meet certain disease activity levels. Participants need to weigh between 45-120 kg and use approved contraception methods. Those with drug-induced lupus, other major diseases that could affect the study, recent high-dose steroids or immunosuppressants, serious infections or a history of severe lupus complications cannot participate.Check my eligibility

What is being tested?

The trial is testing SAR441344's effectiveness in treating SLE against a placebo. It's given either intravenously (IV) or subcutaneously (SC). Over 36 weeks, participants will receive treatment for half that time and visit the clinic every two weeks to compare how well SAR441344 works compared to no active treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, clinical trials like this one typically monitor for any adverse reactions related to the immune system due to the nature of treatments being tested for autoimmune conditions like SLE.

APATURA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with lupus for at least 6 months.

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My weight is between 45 kg and 120 kg.

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My lupus severity score is 6 or more, with symptoms including arthritis and rash.

APATURA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24.

Secondary outcome measures

Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS)

Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) from Baseline to Week 36 End of Study (EoS)

Measurement of anti-drug antibodies (ADA) (before administration at Week 0, 4, 8, 12, 16, 20, 24 and after treatment discontinuation at Week 36)

+15 more

APATURA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR441344Experimental Treatment2 Interventions

SAR441344 intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks

Group II: PlaceboPlacebo Group2 Interventions

Placebo IV loading dose followed by SC, 24 weeks

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,864 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,723 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05039840 — Phase 2

Lupus Research Study Groups: SAR441344, Placebo

Lupus Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05039840 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039840 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus

2021. "Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05039840.

All > Systemic Lupus Erythematosus > Lupus