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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05966480
Other study ID # ESK-001-010
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 26, 2023
Est. completion date December 1, 2025

Study information

Verified date June 2024
Source Alumis Inc
Contact Central Recruiting
Phone (+1) 650-538-2502
Email clinicaltrials@alumis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 388
Est. completion date December 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ESK-001
Oral tablet
Placebo
Oral tablet

Locations

Country Name City State
Argentina Investigator Site #3023 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
Argentina Investigator Site #3009 San Miguel de Tucuman Tucman
Argentina Investigator Site #3010 San Miguel De Tucumán Tucman
Argentina Investigator Site #3015 San Miguel De Tucumán Tucumán
Bulgaria Investigator Site #5521 Plovdiv
Bulgaria Investigator Site #5525 Plovdiv
Bulgaria Investigator Site #5529 Ruse
Bulgaria Investigator Site #5522 Sofia
Bulgaria Investigator Site #5541 Sofia
Bulgaria Investigator Site #5547 Sofia
Chile Investigator Site #3006 Providencia
Chile Investigator Site #3002 Santiago
Colombia Investigator Site #3011 Barranquilla
Colombia Investigator Site #3019 Barranquilla
Colombia Investigator Site #3021 Bogotá
Colombia Investigator Site #3022 Bogotá
Colombia Investigator Site #3020 Cali
Colombia Investigator Site #3003 Chia
Colombia Investigator Site #3014 Medellín
Croatia Investigator Site #5542 Rijeka
Croatia Investigator Site #5543 Split
Denmark Investigator Site #4011 Køge
Georgia Investigator Site #5516 Tbilisi
Georgia Investigator Site #5523 Tbilisi
Georgia Investigator Site #5534 Tbilisi
Georgia Investigator Site #5536 Tbilisi
Georgia Investigator Site #5538 Tbilisi
Germany Investigator Site #4001 Kirchheim Unter Teck
Germany Investigator Site #4004 Koeln
Germany Investigator Site #4003 Leipzig
Germany Investigator Site #4005 Mainz
Germany Investigator Site #4006 Munich
Hungary Investigator Site #5548 Debrecen
Hungary Investigator Site #5544 Gyula
India Investigator Site #6005 Ahmedabad
India Investigator Site #6006 Ahmedabad
India Investigator Site #6010 Ahmedabad
India Investigator Site #6016 Ahmedabad
India Investigator Site #6001 Bangalore
India Investigator Site #6009 Bengaluru
India Investigator Site #6012 Chandigarh
India Investigator Site #6004 Haryana
India Investigator Site #6013 Jaipur
India Investigator Site #6011 Lucknow
India Investigator Site #6008 Nagpur
India Investigator Site # 6015 New Delhi Delhi
India Investigator Site #6007 Pune
India Investigator Site #6014 Pune
India Investigator Site #6002 Surat
India Investigator Site #6003 Surat
Korea, Republic of Investigator Site #8007 Anyang-si
Korea, Republic of Investigator Site #8004 Busan
Korea, Republic of Investigator Site #8002 Namdong Incheon
Korea, Republic of Investigator Site #8012 Seoul
Korea, Republic of Investigator Site #8016 Seoul
Korea, Republic of Investigator Site #8019 Seoul
Mexico Investigator Site #2501 Chihuahua
Mexico Investigator Site #2503 Ciudad de Mexico
Mexico Investigator Site #2506 Ciudad De Mexico
Mexico Investigator Site #2509 Ciudad de Mexico
Mexico Investigator Site #2504 Cuauhtémoc
Mexico Investigator Site #2502 Guadalajara
Mexico Investigator Site #2507 Guadalajara
Mexico Investigator Site #2512 Guadalajara
Mexico Investigator Site #2508 Madero
Mexico Investigator Site #2516 Merida
Mexico Investigator Site #2511 Mérida
Mexico Investigator Site #2514 Mexico City
Mexico Investigator Site # 2517 Naucalpan De Juárez
Mexico Investigator Site #2510 Oaxaca
Mexico Investigator Site #2505 San Luis Potosí
Mexico Investigator Site #2513 Torreon
Peru Investigator Site #3004 Lima
Peru Investigator Site #3013 Lima
Peru Investigator Site #3018 San Martin De Porres
Peru Investigator Site #3005 Santiago De Surco
Peru Investigator Site #3017 Trujillo
Philippines 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
Poland Investigator Site #5518 Bialystok
Poland Investigator Site #5519 Bialystok
Poland Investigator Site #5546 Bialystok
Poland Investigator Site #5531 Bydgoszcz
Poland Investigator Site #5520 Bytom
Poland Investigator Site #5539 Czestochowa
Poland Investigator Site #5533 Kraków
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 Warszawa
Poland Investigator Site #5528 Wroclaw
Romania Investigator Site #5526 Bucuresti
Romania Investigator Site #5530 Bucuresti
Romania Investigator Site #5549 Bucuresti
Spain Investigator Site #4013 A Coruña
Spain Investigator Site #4008 Alicante
Spain Investigator Site #4007 Barcelona
Spain Investigator Site #4002 Sevilla
Spain Investigator Site #4009 Valencia
Taiwan 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
United Kingdom Investigator Site #4017 Leeds
United Kingdom Investigator Site #4015 London
United Kingdom Investigator Site #4016 London
United Kingdom Investigator Site #4014 Southampton
United States Investigator Site #1101 Albuquerque New Mexico
United States Investigator Site #1046 Anniston Alabama
United States Investigator Site #1048 Aventura Florida
United States Investigator Site #1063 Avon Park Florida
United States Investigator Site #1058 Brooklyn New York
United States Investigator Site #1077 Burlington Massachusetts
United States Investigator Site #1056 Charlotte North Carolina
United States Investigator Site #1095 Charlotte North Carolina
United States Investigator Site #1045 Clearwater Florida
United States Investigator Site #1052 College Park Georgia
United States Investigator Site #1049 Colleyville Texas
United States Investigator Site #1055 Coral Gables Florida
United States Investigator Site #1097 Coral Springs Florida
United States Investigator Site #1051 DeBary Florida
United States Investigator Site #1087 Hollywood Florida
United States Investigator Site #1096 Hoover Alabama
United States Investigator Site #1094 Houston Texas
United States Investigator Site #1092 Lansing Michigan
United States Investigator Site #1050 Los Alamitos California
United States Investigator Site #1044 Memphis Tennessee
United States Investigator Site #1057 Miami Florida
United States Investigator Site #1060 Miami Florida
United States Investigator Site #1093 Miami Florida
United States Investigator Site #1062 Pittsburgh Pennsylvania
United States Investigator Site #1090 Plantation Florida
United States Investigator Site #1089 Tampa Florida
United States Investigator Site #1061 Upland California

Sponsors (1)

Lead Sponsor Collaborator
Alumis Inc

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Chile,  Colombia,  Croatia,  Denmark,  Georgia,  Germany,  Hungary,  India,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo Week 48
Secondary To assess the safety and tolerability of multiple dose levels of ESK-001 Safety and Tolerability will be assessed with clinical and laboratory assessments including blood tests for liver and kidney function, ECGs, hematological measures and physical examinations throughout the time of the study and safety follow up. The number and proportion of TEAEs, SAEs, AEs of greater than grade 3 severity and AEs of Clinical Interest will be recorded. Week 48
Secondary To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of =4 (SRI[4]) response at Week 48 Week 48
Secondary To compare corticosteroid use in patients at Week 48 To compare the number and percentage of patients using corticosteroids and continuous summaries of dose used will be assessed as well as the frequency and percentage of patients able to taper corticosteroids and maintain low doses following taper. Week 48
Secondary To compare the effect on cutaneous disease activity measured by the proportion of patients with a CLASI activity score of =8 at baseline achieving = 50% reduction in the CLASI activity score at Week 48 between doses of ESK-001 and placebo Week 48
Secondary To compare the effect on disease activity measured by the proportion of patients achieving BICLA responses at Week 48 between doses of ESK-001 and placebo by stratification groups Week 48
Secondary To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48 Week 48
Secondary To compare the annualized flare rate through Week 48 Week 48
Secondary To use the SF-36 (Short Form-36 item QoL measure) to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SF-36 (Short Form-36 item QoL measure) Questionnaire which uses a scale of 0 to 100. The higher numbers mean better health. Week 48
Secondary To use the SLE-specific Lupus Quality of Life (LQoL) questionnaire to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SLE-specific Lupus Quality of Life (LQoL) questionnaire which uses a scale of 0 to 100. The higher numbers mean better health. Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the SLE Disease Activity Index 2000 (SLEDAI2K) measured on a scale of 0 to 105 where the higher numbers mean more disease activity. Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the British Isle Lupus Assessment Group 2004 (BILAG-2004) with a scale of A to E (A meaning very active disease and E no current or previous disease). Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the Physician's Global Assessment (PGA) evaluating disease response using the 4-point VAS (Visual Analog Scale) of 0 to 3 (0 means no flares and 3 means severe flare in disease). Week 48
Secondary To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo To compare patient-reported fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire between doses of ESK-001 and placebo, where the score range is 0 to 52 and a lower score indicates greater fatigue/worse outcome. Week 48
Secondary To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the PtGA (Patient Global Assessment) instrument. Patients record on a visual analog scale (VAS) how well or badly they feel as a result of the disease in their own estimation over the course of the study. Week 48
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