Last updated 16 days ago
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
388 patients around the world
Available in Spain, Colombia, United States, Mexico, Chile, Peru, Argentina
This study will consist of a 5 week screening period, 48 week treatment period, and a 4
week follow up period for a total of 57 weeks. Each participant will be randomized to
receive ESK-001 or placebo for 48 weeks. An open label extension study will be available
for those patients who complete the study.
Alumis Inc
388Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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.
- Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessmentsActive, proliferative lupus nephritis that in the Investigator's opinion may require treatment not allowed by the protocolCurrent 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 indicatedKnown history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infectionCurrently active, clinically significant infection of any kindClinically 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 ICFAny infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1Any 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 1Other protocol-defined inclusion/exclusion criteria apply
StudyLUMUS
SponsorAlumis Inc
Conditions
Systemic lupus erythematosus
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05966480
