Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus

Study Purpose

The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05966480
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alumis Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Bulgaria, Chile, Colombia, Croatia, Denmark, Georgia, Germany, Hungary, India, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	SLE

Additional Details

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.

Arms & Interventions

Arms

Experimental: ESK-001 Dose Level 1

ESK-001 administered as an oral tablet

Experimental: ESK-001 Dose Level 2

ESK-001 administered as an oral tablet

Experimental: ESK-001 Dose Level 3

ESK-001 administered as an oral tablet

Placebo Comparator: Placebo

Placebo administered as an oral tablet

Interventions

Drug: - ESK-001

Oral tablet

Drug: - Placebo

Oral tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigator Site #1046, Anniston, Alabama

Status

Recruiting

Address

Investigator Site #1046

Anniston, Alabama, 36207

Site Contact

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