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Sponsor Name:

Sanofi

Purpose of Study:

The purpose of the APATURA study is to evaluate the efficacy and safety of an investigational medication compared with placebo, in addition to standard of care SLE medication, in adult participants with active Systemic Lupus Erythematosus (SLE). In other words, we are studying whether a new drug is safe and can decrease lupus activity when it is taken with other lupus medicines.

What Does this Study Involve? 

• The APATURA study duration is 40 weeks and includes 17 visits to the study site, with the possibility of home visit/phone call for specific visits
• The APATURA study is a worldwide clinical trial including 15 countries with more than 80 site locations
• Approximately 116 SLE patients with moderate to severe disease who are under current treatment of SLE will be involved in the study
• Participants will continue their current SLE medication during the study
• Participants will receive either active study medication or placebo (which looks like the study medication but contains no active medication)
• All study-related care and study medication are covered throughout the study duration at no charge

You may participate in the study if you are:

• Between the ages of 18-70 years of age
• Diagnosed with SLE for at least 6 months
• Currently taking medication to treat SLE but still experiencing disease-related symptoms 

If you have any of the following, you will not be able to participate in the study: 

• Are pregnant, lactating, breastfeeding, or planning pregnancy during the study period
  - Have any of the following conditions in addition to SLE; Rheumatoid arthritis, Ulcerative colitis, Crohn's disease
• Have used cyclophosphamide within 3 months prior to the screening visit, or previous treatment with rituximab within 12 months 

Other protocol-defined inclusion/exclusion criteria would be considered for eligibility.

Study Type:

• Interventional (Clinical Trial)
• Phase II

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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.