Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
NCT ID: NCT05966480
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
408 participants
INTERVENTIONAL
2023-06-26
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ESK-001 Dose Level 1
ESK-001 administered as an oral tablet
ESK-001
Oral tablet
ESK-001 Dose Level 2
ESK-001 administered as an oral tablet
ESK-001
Oral tablet
ESK-001 Dose Level 3
ESK-001 administered as an oral tablet
ESK-001
Oral tablet
Placebo
Placebo administered as an oral tablet
Placebo
Oral tablet
Interventions
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ESK-001
Oral tablet
Placebo
Oral tablet
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Alumis Inc
INDUSTRY
Responsible Party
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Locations
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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 #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 #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 #3023
Buenos Aires, , Argentina
Investigator Site #3008
Mendoza, , 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
Investigator Site #6007
Pune, , India
Investigator Site #6002
Surat, , India
Investigator Site #6003
Surat, , India
Investigator Site #2501
Chihuahua City, , Mexico
Investigator Site #2504
Cuauhtémoc, , Mexico
Investigator Site #2502
Guadalajara, , Mexico
Investigator Site #2512
Guadalajara, , Mexico
Investigator Site #2507
Guadalajara, , Mexico
Investigator Site #2508
Madero, , Mexico
Investigator Site #2509
Mexico City, , Mexico
Investigator Site #2514
Mexico City, , Mexico
Investigator Site #2503
Mexico City, , Mexico
Investigator Site #2506
Mexico City, , Mexico
Investigator Site #2511
Mérida, , Mexico
Investigator Site #2516
Mérida, , Mexico
Investigator Site # 2517
Naucalpan, , Mexico
Investigator Site #2510
Oaxaca City, , Mexico
Investigator Site #2505
San Luis Potosí City, , Mexico
Investigator Site #2513
Torreón, , Mexico
Investigator Site #3013
Lima, , Peru
Investigator Site #3004
Lima, , Peru
Investigator Site #3018
San Martín de Porres, , Peru
Investigator Site #3005
Santiago de Surco, , Peru
Investigator Site #3017
Trujillo, , Peru
Investigator Site #8003
Angeles City, , Philippines
Investigator Site #8009
Iloilo City, , Philippines
Investigator Site #8011
Lipa City, , Philippines
Investigator Site #8001
Manila, , Philippines
Investigator Site #8010
Manila, , Philippines
Investigator Site #8018
Manila, , Philippines
Investigator Site #8006
Quezon City, , Philippines
Investigator Site #5519
Bialystok, , Poland
Investigator Site #5546
Bialystok, , Poland
Investigator Site #5518
Bialystok, , Poland
Investigator Site #5531
Bydgoszcz, , Poland
Investigator Site #5520
Bytom, , Poland
Investigator Site #5539
Częstochowa, , Poland
Investigator Site #5533
Krakow, , Poland
Investigator Site #5537
Nadarzyn, , Poland
Investigator Site #5545
Poznan, , Poland
Investigator Site #5535
Sosnowiec, , Poland
Investigator Site #5532
Szczecin, , Poland
Investigator Site #5527
Warsaw, , Poland
Investigator Site #5540
Warsaw, , Poland
Investigator Site #5528
Wroclaw, , Poland
Investigator site #3028
Caguas, , Puerto Rico
Investigator site #3029
San Juan, , Puerto Rico
Investigator Site #5530
Bucharest, , Romania
Investigator Site #5549
Bucharest, , Romania
Investigator Site #5526
Bucharest, , Romania
Investigator Site #8007
Anyang-si, , South Korea
Investigator Site #8004
Busan, , South Korea
Investigator Site #8016
Seoul, , South Korea
Investigator Site #8019
Seoul, , South Korea
Investigator Site #8012
Seoul, , South Korea
Investigator Site #4013
A Coruña, , Spain
Investigator Site #4008
Alicante, , Spain
Investigator Site #4007
Barcelona, , Spain
Investigator Site #4002
Seville, , Spain
Investigator Site #4009
Valencia, , Spain
Investigator Site #8013
Chiayi City, , Taiwan
Investigator Site #8014
Kaohsiung City, , Taiwan
Investigator Site #8008
Taichung, , Taiwan
Investigator Site #8015
Taichung, , Taiwan
Investigator Site #8017
Taipei, , Taiwan
Investigator Site #4017
Leeds, , United Kingdom
Investigator Site #4015
London, , United Kingdom
Investigator Site #4016
London, , United Kingdom
Investigator Site #4014
Southampton, , United Kingdom
Countries
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Other Identifiers
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ESK-001-010
Identifier Type: -
Identifier Source: org_study_id
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