A Study to Investigate the Safety and Efficacy of an Active Drug Given Alone or in Combination with another active drug in Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Brief summary

The main objective of this study is to evaluate the safety and efficacy of a combination of 3 active drugs vs placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses for further development.

Interventional study

Systemic Lupus Erythematosus (SLE)
341 patients
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  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Eligibility criteria

Participant attributes:
Male and Female


From 18 Years to 65 Years.

Inclusion Criteria:

- Participant has clinical diagnosis of SLE at least 24 weeks prior to screening,
meeting at least 4 of the 11 revised Criteria for Classification of SLE according to
the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least
4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion
and 1 immunologic criterion.

- At Screening, must have at least one of the following:

- antinuclear antibody(ANA)+ (titer >= 1:80).

- anti-dsDNA+.

- anti-Smith+.

- SLEDAI-2K >= 6 despite background therapy as reported and independently adjudicated
(clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at

- If 4 points of the required entry points are for arthritis, there must also be a
minimum of 3 tender and 3 swollen joints.

- If participant has rash and PI considers it to be attributable to SLE,
participant must consent to skin photograph collection for adjudication.

- Score must be re-confirmed at the Baseline visit.

- Physician's Global Assessment (PhGA) >= 1 during screening period.

- Must be on background treatment, stable for 30 days, at Baseline and throughout the
study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg),
azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine,
tacrolimus, and/or methotrexate (MTX) (<=20 mg).

- No combinations of the above with immunomodulators other than prednisone (or
equivalents) and antimalarials.

Exclusion Criteria:

- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or
equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

All the cities where the clinical studies are located

Hamilton - L8S 4K1
London - N6A 4V2
Toronto - M5T 2S8
Sherbrooke - J1L 0H8

More information about this study