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Novartis SIRIUS-SLE 1 Study (lupus)

Lupus | SLE

To see if ADDING a new biologic (ianalumab) improves lupus of patients with active lupus despite the medications they are taking.

Participants will be randomly assigned, like flipping a coin, to one of three groups and will have a:

3 in 7 chance of receiving ianalumab every 4 weeks
3 in 7 chance of receiving ianalumab every 12 weeks.
2 in 7 chance of receiving placebo (fake study drug).

It is given by injection (two at each visit) into the fatty layer of the arms, abdomen or thighs.

There may be up to 27 visits over a maximum of 2 years.

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Participation Requirements

  • Sex:

    Female, Male

  • Eligible Ages:

    18 to 90

Participation Criteria

Inclusion Criteria:
Male and females, with active lupus (positive ANA) in spite of the current lupus medications being taken.

Current lupus medications can be:
- Corticosteroids alone (e.g. prednisone) 30 mg or less per day, and the dose must be unchanged for at least 8 weeks before the first dose of study drug.

- Corticosteroids taken along with other medications, in which case the corticosteroid dose must be unchanged for at least 2 weeks before the first dose of study drug.

- Antimalarials (e.g. plaquenil) and/or ONE of: methotrexate, imuran, mycophenolate mofetil, for at least 12 weeks before screening and the dose must have been stable (unchanged) for at least 8 weeks before screening.

Much of the other criteria is based on laboratory results done at the Screening Visit and the study doctors assessment/examination at the Screening Visit.
Exclusion Criteria:
Chronic infection with Hepatitis B, Hepatitis C as they could worsen if on the study drug.
Active Tuberculosis as it could worsen if on the study drug.
History or organ or stem cell transplant.
Uncontrolled medical conditions, such as uncontrolled high blood pressure, diabetes.
History of cancer within the past 5 years (EXCEPT possibly basal cell skin cancer or cervix cancer)
Pregnancy or breast feeding.
Laboratory results that are abnormal and outside what the sponsor will accept.

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Edna Hutchings

[email protected]
780-492-8290
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00138887