ESK-001 for Lupus
(LUMUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new medication called ESK-001 to see if it can help adults with SLE, a chronic autoimmune disease. The study will check the effectiveness and safety of ESK-001 over several months.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of certain medications, like oral corticosteroids, antimalarials, or specific DMARDs (disease-modifying antirheumatic drugs), before and during the study. You should not increase the dose of these medications between screening and the start of the trial.
Are You a Good Fit for This Trial?
Adults with active Systemic Lupus Erythematosus (SLE) for at least 6 months, meeting specific disease criteria and on stable medications like Azathioprine or Methotrexate. Excluded are those with chronic infections, other autoimmune diseases that could affect results, recent use of oral anti-infectives, severe unrelated conditions, or a history of significant neuropsychiatric SLE.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ESK-001 or placebo for 48 weeks to assess efficacy, safety, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- ESK-001
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alumis Inc
Lead Sponsor