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Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus

Sheetal Desai


A Study On:

  • Systemic Lupus Erythematosus

Status:

  • Open

Eligibility

Active Systemic Lupus Erythematosus
18 Years to 75 Years (Adult, Older Adult)

Interested in joining this trial?

Official Title

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in
Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy


Eligibility

You can join if...

Inclusion Criteria:

  1. Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  2. Participant is aged between 18 and 75.
  3. Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody greater than or equal to 1:80 by immunofluorescence on Hep-2 cells being present at screening.
  4. Hybrid SLEDAI score greater than or equal to 6 points with a "Clinical" hSLEDAI score greater than or equal to 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
  5. British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of greater than or equal to 1 A item or greater than or equal to 2 B items.
  6. Must be taking greater than or equal to 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants must be on a stable dose for greater than or equal to 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for greater than or equal to 2 weeks prior to screening.
  7. For participants taking OCS, dose must be less than or equal to 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for greater than or equal to 2 weeks prior to screening visit.
  8. Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.
  9. Disease activity: active disease as indicated by clinical hSLEDAI score greater than or equal to 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters).

Exclusion Criteria: Contact study investigator for more information.

Get in touch with our study team