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ACTIVE NOT RECRUITING

NCT05966480

PHASE2

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

Sponsor: Alumis Inc

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2023-06-26

Completion Date

2027-09-01

Last Updated

2026-07-21

Healthy Volunteers

Conditions

SLE

Interventions

DRUG

Envudeucitinib

Oral tablet

DRUG

Placebo

Oral tablet

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

Locations (169)

Investigator Site #1046

Anniston, Alabama, United States

Investigator Site #1104

La Jolla, California, United States

Investigator Site #1050

Los Alamitos, California, United States

Investigator Site #1168

Mission Hills, California, United States

Investigator Site #1174

Napa, California, United States

Investigator Site #1061

Upland, California, United States

Investigator Site #1048

Aventura, Florida, United States

Investigator Site #1063

Avon Park, Florida, United States

Investigator Site #1176

Bradenton, Florida, United States

Investigator Site #1045

Clearwater, Florida, United States

Investigator Site #1055

Coral Gables, Florida, United States

Investigator Site #1097

Coral Springs, Florida, United States

Investigator Site #1091

Daytona Beach, Florida, United States

Investigator Site #1051

DeBary, Florida, United States

Investigator Site #1087

Hollywood, Florida, United States

Investigator Site #1135

Kissimmee, Florida, United States

Investigator Site #1060

Miami, Florida, United States

Investigator Site #1093

Miami, Florida, United States

Investigator Site #1057

Miami, Florida, United States

Investigator Site #1067

Miami Lakes, Florida, United States

Investigator Site #1090

Plantation, Florida, United States

Investigator Site #1089

Tampa, Florida, United States

Investigator Site #1170

Atlanta, Georgia, United States

Investigator Site #1052

College Park, Georgia, United States

Investigator Site #1204

Chesterfield, Missouri, United States

Investigator site #1209

Las Vegas, Nevada, United States

Investigator Site #1189

Sparta, New Jersey, United States

Investigator Site #1101

Albuquerque, New Mexico, United States

Investigator Site #1058

Brooklyn, New York, United States

Investigator Site #1088

New York, New York, United States

Investigator Site #1175

Queens, New York, United States

Investigator Site #1095

Charlotte, North Carolina, United States

Investigator Site #1056

Charlotte, North Carolina, United States

Investigator Site #1173

Charlotte, North Carolina, United States

Investigator Site #1171

Philadelphia, Pennsylvania, United States

Investigator Site #1062

Pittsburgh, Pennsylvania, United States

Investigator Site #1044

Memphis, Tennessee, United States

Investigator Site #1195

Carrollton, Texas, United States

Investigator Site #1049

Colleyville, Texas, United States

Investigator Site #1071

Fort Worth, Texas, United States

Investigator Site #1094

Houston, Texas, United States

Investigator Site #1169

Houston, Texas, United States

Investigator site #1178

Houston, Texas, United States

Investigator Site #1187

Red Oak, Texas, United States

Investigator site #1053

San Antonio, Texas, United States

Investigator Site #1186

San Antonio, Texas, United States

Investigator Site #1172

Spring, Texas, United States

Investigator Site #1194

Tomball, Texas, United States

Investigator Site #3023

Buenos Aires, Buenos Aires, Argentina

Investigator Site #3012

CABA, Buenos Aires, Argentina

Investigator Site #3001

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Investigator Site #3016

La Plata, Buenos Aires, Argentina

Investigator Site #3008

Mendoza, Mendoza Province, Argentina

Investigator Site #3009

San Miguel de Tucumán, Tucman, Argentina

Investigator Site #3010

San Miguel de Tucumán, Tucman, Argentina

Investigator Site #3015

San Miguel de Tucumán, Tucumán Province, Argentina

Investigator Site #5603

Haskovo, Bulgaria

Investigator Site #5602

Pleven, Bulgaria

Investigator Site #5525

Plovdiv, Bulgaria

Investigator Site #5521

Plovdiv, Bulgaria

Investigator Site #5529

Rousse, Bulgaria

Investigator Site #5522

Sofia, Bulgaria

Investigator Site #5547

Sofia, Bulgaria

Investigator Site #3006

Providencia, Chile

Investigator Site #3002

Santiago, Chile

Investigator Site #3019

Barranquilla, Colombia

Investigator Site #3011

Barranquilla, Colombia

Investigator Site #3021

Bogotá, Colombia

Investigator Site #3022

Bogotá, Colombia

Investigator Site #3020

Cali, Colombia

Investigator Site #3003

Chía, Colombia

Investigator Site #3014

Medellín, Colombia

Investigator Site #5542

Rijeka, Croatia

Investigator Site #5543

Split, Croatia

Investigator Site #4012

Aarhus, Denmark

Investigator Site #4011

Køge, Denmark

Investigator Site #5516

Tbilisi, Georgia

Investigator Site #5523

Tbilisi, Georgia

Investigator Site #5538

Tbilisi, Georgia

Investigator Site #5536

Tbilisi, Georgia

Investigator Site #5534

Tbilisi, Georgia

Investigator Site #5517

Tbilisi, Georgia

Investigator Site #4003

Leipzig, Germany

Investigator Site #4005

Mainz, Germany

Investigator Site #4006

Munich, Germany

Investigator Site #5548

Debrecen, Hungary

Investigator Site #5544

Gyula, Hungary

Investigator Site # 6015

New Delhi, National Capital Territory of Delhi, India

Investigator Site #6005

Ahmedabad, India

Investigator Site #6010

Ahmedabad, India

Investigator Site #6016

Ahmedabad, India

Investigator Site #6006

Ahmedabad, India

Investigator Site #6001

Bangalore, India

Investigator Site #6009

Bengaluru, India

Investigator Site #6012

Chandigarh, India

Investigator Site #6004

Haryāna, India

Investigator Site #6013

Jaipur, India

Investigator Site #6011

Lucknow, India

Investigator Site #6008

Nagpur, India

Investigator Site #6014

Pune, India

And 69 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (169)