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Assessing ESK-001 for treating active systemic lupus erythematosus

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus

Phase 2 Interventional Alumis Inc · NCT05966480

This study is testing a new treatment called ESK-001 to see if it can help adults with active lupus feel better and stay safe while using it.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment388 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAlumis Inc Industry-sponsored
Drugs / interventionsmethotrexate, prednisone
Locations175 sites (Anniston, Alabama and 174 other locations)
Trial IDNCT05966480 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of ESK-001 in adult patients with active systemic lupus erythematosus (SLE) through a randomized, placebo-controlled design. Participants will undergo a 5-week screening period followed by a 48-week treatment phase where they will receive either ESK-001 or a placebo. The study will also include a 4-week follow-up period and an open-label extension for those who complete the initial study. The primary focus is on measuring clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of ESK-001.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of active systemic lupus erythematosus for at least six months and specific clinical criteria indicating disease activity.

Not a fit: Patients with drug-induced lupus or other autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from active systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise in treating systemic lupus erythematosus with similar approaches, but the specific efficacy of ESK-001 remains to be established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Patients with 6 or more months of SLE according to the 2019 EULAR/ACR criteria, have positive autoantibodies or low complement at screening, and have active SLE as measured by SLEDAI-2K of 6 or more, or 4 or more if joint involvement is present.

Patients need to be on treatment which can be:

* A stable dose of oral corticosteroid (≤40 mg/day prednisone or equivalent) for a minimum of 2 weeks prior to signing of the informed consent form (ICF) at the Screening Visit. The dose of oral corticosteroid the patient is taking should not increase between screening and Week 0 (Day 1).
* And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
* And/or no more than 1 of the following conventional DMARDS:

  * Azathioprine ≤200 mg/day
  * Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
  * Oral, subcutaneous, or intramuscular (IM) methotrexate ≤20 mg/week.

Exclusion Criteria:

* Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments
* Active, proliferative lupus nephritis that in the Investigator's opinion may require treatment not allowed by the protocol
* Current disease other than SLE that, in the opinion of the Investigator, is likely to interfere with SLE disease activity assessments. Examples include severe fibromyalgia, severe osteoarthritis and severe cardiorespiratory diseases.
* Active severe or unstable neuropsychiatric SLE including, but not limited to the following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending or transverse myelitis, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures; cerebellar ataxia; and mononeuritis multiplex.

  * That would make the patient unable to fully understand the ICF, or
  * Where, in the opinion of the Principal Investigator, protocol-specified SOC is insufficient and utilization of a more aggressive therapeutic approach not permitted in the protocol, is indicated
* Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection
* Currently active, clinically significant infection of any kind
* Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF (chronic fungal nail infections are allowed)
* Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF
* Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
* Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years), or ophthalmic herpes (ever)

  * Active herpes zoster infection within 12 weeks of prior to signing the ICF
  * Active herpes simplex virus within 4 weeks of Day 1
* Other protocol-defined inclusion/exclusion criteria apply

Where this trial is running

Anniston, Alabama and 174 other locations

+125 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SLEAutoimmune DiseasesImmune System DiseasesConnective Tissue DiseasesImmune-mediated DiseasesActive Systemic Lupus ErythematosusLupusLUMUS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.