SLEek

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

Status:
Completed
Conditions:
Systemic Lupus Erythematosus (SLE)
Enrollment:
341 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-130
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 65 Years.

Inclusion Criteria:

- Participant has clinical diagnosis of Systemic Lupus Erythematosus (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 (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and
independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic
brain syndrome) at Screening:

- 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 Principal Investigator (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 prior to 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

More information about this study

clinicaltrials.gov