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

NCT05966480 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ESK-001-010
• Study Type: interventional
• Target: 408
• Locations: 21 countries
• Sites: 169

Brief 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.

Conditions

SLE

Keywords

Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Immune-mediated Diseases; Active Systemic Lupus Erythematosus; SLE; Lupus; LUMUS; Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• To assess the safety and tolerability of multiple dose levels of ESK-001

  Week 48

• 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

• To compare corticosteroid use in patients at Week 48

  Week 48

• 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

• 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

Study Arms (4)

ESK-001 Dose Level 1

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: Envudeucitinib

ESK-001 Dose Level 2

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: Envudeucitinib

ESK-001 Dose Level 3

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: Envudeucitinib

Placebo

PLACEBO COMPARATOR

Placebo administered as an oral tablet

Drug: Placebo

Interventions

Envudeucitinib DRUG

Oral tablet

ESK-001 Dose Level 1; ESK-001 Dose Level 2; ESK-001 Dose Level 3

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (169)

Investigator Site #1046

Anniston, Alabama, 36207, United States

Location

Investigator Site #1104

La Jolla, California, 92037, United States

Location

Investigator Site #1050

Los Alamitos, California, 90720, United States

Location

Investigator Site #1168

Mission Hills, California, 91345, United States

Location

Investigator Site #1174

Napa, California, 94558, United States

Location

Investigator Site #1061

Upland, California, 91786, United States

Location

Investigator Site #1048

Aventura, Florida, 33180, United States

Location

Investigator Site #1063

Avon Park, Florida, 33825, United States

Location

Investigator Site #1176

Bradenton, Florida, 34209, United States

Location

Investigator Site #1045

Clearwater, Florida, 33765, United States

Location

Investigator Site #1055

Coral Gables, Florida, 33134, United States

Location

Investigator Site #1097

Coral Springs, Florida, 33071, United States

Location

Investigator Site #1091

Daytona Beach, Florida, 32117, United States

Location

Investigator Site #1051

DeBary, Florida, 32713, United States

Location

Investigator Site #1087

Hollywood, Florida, 33020, United States

Location

Investigator Site #1135

Kissimmee, Florida, 34741, United States

Location

Investigator Site #1060

Miami, Florida, 33136, United States

Location

Investigator Site #1093

Miami, Florida, 33155, United States

Location

Investigator Site #1057

Miami, Florida, 33176, United States

Location

Investigator Site #1067

Miami Lakes, Florida, 33014, United States

Location

Investigator Site #1090

Plantation, Florida, 33324, United States

Location

Investigator Site #1089

Tampa, Florida, 33606, United States

Location

Investigator Site #1170

Atlanta, Georgia, 30328, United States

Location

Investigator Site #1052

College Park, Georgia, 30329, United States

Location

Investigator Site #1204

Chesterfield, Missouri, 63017, United States

Location

Investigator site #1209

Las Vegas, Nevada, 89102, United States

Location

Investigator Site #1189

Sparta, New Jersey, 07871, United States

Location

Investigator Site #1101

Albuquerque, New Mexico, 87102, United States

Location

Investigator Site #1058

Brooklyn, New York, 11201, United States

Location

Investigator Site #1088

New York, New York, 10032, United States

Location

Investigator Site #1175

Queens, New York, 11001, United States

Location

Investigator Site #1095

Charlotte, North Carolina, 28207, United States

Location

Investigator Site #1056

Charlotte, North Carolina, 28210, United States

Location

Investigator Site #1173

Charlotte, North Carolina, 28277, United States

Location

Investigator Site #1171

Philadelphia, Pennsylvania, 19114, United States

Location

Investigator Site #1062

Pittsburgh, Pennsylvania, 15224, United States

Location

Investigator Site #1044

Memphis, Tennessee, 38119, United States

Location

Investigator Site #1195

Carrollton, Texas, 75006, United States

Location

Investigator Site #1049

Colleyville, Texas, 76034, United States

Location

Investigator Site #1071

Fort Worth, Texas, 76177, United States

Location

Investigator Site #1094

Houston, Texas, 77054, United States

Location

Investigator Site #1169

Houston, Texas, 77095, United States

Location

Investigator site #1178

Houston, Texas, 77386, United States

Location

Investigator Site #1187

Red Oak, Texas, 75154, United States

Location

Investigator site #1053

San Antonio, Texas, 78215, United States

Location

Investigator Site #1186

San Antonio, Texas, 78229, United States

Location

Investigator Site #1172

Spring, Texas, 77388, United States

Location

Investigator Site #1194

Tomball, Texas, 77375, United States

Location

Investigator Site #3023

Buenos Aires, Buenos Aires, C1114 AAH, Argentina

Location

Investigator Site #3012

CABA, Buenos Aires, C1425, Argentina

Location

Investigator Site #3001

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1221ADC, Argentina

Location

Investigator Site #3016

La Plata, Buenos Aires, B1900, Argentina

Location

Investigator Site #3008

Mendoza, Mendoza Province, M5500CPH, Argentina

Location

Investigator Site #3009

San Miguel de Tucumán, Tucman, T4000BRD, Argentina

Location

Investigator Site #3010

San Miguel de Tucumán, Tucman, T4000BRD, Argentina

Location

Investigator Site #3015

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

Location

Investigator Site #5603

Haskovo, 6300, Bulgaria

Location

Investigator Site #5602

Pleven, 2873, Bulgaria

Location

Investigator Site #5525

Plovdiv, 4003, Bulgaria

Location

Investigator Site #5521

Plovdiv, Bulgaria

Location

Investigator Site #5529

Rousse, 7002, Bulgaria

Location

Investigator Site #5522

Sofia, 1407, Bulgaria

Location

Investigator Site #5547

Sofia, 1463, Bulgaria

Location

Investigator Site #3006

Providencia, 7510586, Chile

Location

Investigator Site #3002

Santiago, 75500587, Chile

Location

Investigator Site #3019

Barranquilla, 11111, Colombia

Location

Investigator Site #3011

Barranquilla, 80020, Colombia

Location

Investigator Site #3021

Bogotá, 110221, Colombia

Location

Investigator Site #3022

Bogotá, 504, Colombia

Location

Investigator Site #3020

Cali, 760035, Colombia

Location

Investigator Site #3003

Chía, 250001, Colombia

Location

Investigator Site #3014

Medellín, 50034, Colombia

Location

Investigator Site #5542

Rijeka, 51000, Croatia

Location

Investigator Site #5543

Split, 21000, Croatia

Location

Investigator Site #4012

Aarhus, Denmark

Location

Investigator Site #4011

Køge, 4600, Denmark

Location

Investigator Site #5516

Tbilisi, 0168, Georgia

Location

Investigator Site #5523

Tbilisi, 102, Georgia

Location

Investigator Site #5538

Tbilisi, 112, Georgia

Location

Investigator Site #5536

Tbilisi, 114, Georgia

Location

Investigator Site #5534

Tbilisi, 180, Georgia

Location

Investigator Site #5517

Tbilisi, Georgia

Location

Investigator Site #4003

Leipzig, 4103, Germany

Location

Investigator Site #4005

Mainz, 55131, Germany

Location

Investigator Site #4006

Munich, 80336, Germany

Location

Investigator Site #5548

Debrecen, 4032, Hungary

Location

Investigator Site #5544

Gyula, Hungary

Location

Investigator Site # 6015

New Delhi, National Capital Territory of Delhi, 110 029, India

Location

Investigator Site #6005

Ahmedabad, 380005, India

Location

Investigator Site #6010

Ahmedabad, 380006, India

Location

Investigator Site #6016

Ahmedabad, 380013, India

Location

Investigator Site #6006

Ahmedabad, 380015, India

Location

Investigator Site #6001

Bangalore, 560034, India

Location

Investigator Site #6009

Bengaluru, 560010, India

Location

Investigator Site #6012

Chandigarh, 160012, India

Location

Investigator Site #6004

Haryāna, 122001, India

Location

Investigator Site #6013

Jaipur, 302004, India

Location

Investigator Site #6011

Lucknow, 226014, India

Location

Investigator Site #6008

Nagpur, 440012, India

Location

Investigator Site #6014

Pune, 411007, India

Location

Investigator Site #6007

Pune, 411057, India

Location

Investigator Site #6002

Surat, 395001, India

Location

Investigator Site #6003

Surat, 395002, India

Location

Investigator Site # 2517

Naucalpan, State of Mexico, 54769, Mexico

Location

Investigator Site #2501

Chihuahua City, 31000, Mexico

Location

Investigator Site #2504

Cuauhtémoc, 6720, Mexico

Location

Investigator Site #2502

Guadalajara, 44160, Mexico

Location

Investigator Site #2512

Guadalajara, 44620, Mexico

Location

Investigator Site #2507

Guadalajara, 44650, Mexico

Location

Investigator Site #2508

Madero, 7760, Mexico

Location

Investigator Site #2509

Mexico City, 14080, Mexico

Location

Investigator Site #2514

Mexico City, 3100, Mexico

Location

Investigator Site #2503

Mexico City, 3720, Mexico

Location

Investigator Site #2506

Mexico City, 6700, Mexico

Location

Investigator Site #2511

Mérida, 97070, Mexico

Location

Investigator Site #2516

Mérida, 97070, Mexico

Location

Investigator Site #2510

Oaxaca City, 68000, Mexico

Location

Investigator Site #2505

San Luis Potosí City, 78213, Mexico

Location

Investigator Site #2513

Torreón, 27000, Mexico

Location

Investigator Site #3013

Lima, 15047, Peru

Location

Investigator Site #3004

Lima, 15801, Peru

Location

Investigator Site #3018

San Martín de Porres, 15102, Peru

Location

Investigator Site #3005

Santiago de Surco, 15023, Peru

Location

Investigator Site #3017

Trujillo, 13001, Peru

Location

Investigator Site #8003

Angeles City, Philippines

Location

Investigator Site #8009

Iloilo City, Philippines

Location

Investigator Site #8011

Lipa City, Philippines

Location

Investigator Site #8001

Manila, Philippines

Location

Investigator Site #8010

Manila, Philippines

Location

Investigator Site #8018

Manila, Philippines

Location

Investigator Site #8006

Quezon City, Philippines

Location

Investigator Site #5520

Bytom, Bytom, 41-902, Poland

Location

Investigator Site #5519

Bialystok, 15-077, Poland

Location

Investigator Site #5546

Bialystok, 15-297, Poland

Location

Investigator Site #5518

Bialystok, 15-707, Poland

Location

Investigator Site #5531

Bydgoszcz, 85-168, Poland

Location

Investigator Site #5539

Częstochowa, 42-200, Poland

Location

Investigator Site #5533

Krakow, 30-363, Poland

Location

Investigator Site #5537

Nadarzyn, 05-830, Poland

Location

Investigator Site #5545

Poznan, 61-397, Poland

Location

Investigator Site #5535

Sosnowiec, 41-200, Poland

Location

Investigator Site #5532

Szczecin, 71-252, Poland

Location

Investigator Site #5527

Warsaw, 00-215, Poland

Location

Investigator Site #5540

Warsaw, 02-637, Poland

Location

Investigator Site #5528

Wroclaw, 50-088, Poland

Location

Investigator site #3028

Caguas, 00725, Puerto Rico

Location

Investigator site #3029

San Juan, 00909-1908, Puerto Rico

Location

Investigator Site #5530

Bucharest, 11025, Romania

Location

Investigator Site #5549

Bucharest, 11057, Romania

Location

Investigator Site #5526

Bucharest, 11172, Romania

Location

Investigator Site #8007

Anyang-si, 14068, South Korea

Location

Investigator Site #8004

Busan, 49241, South Korea

Location

Investigator Site #8016

Seoul, 3080, South Korea

Location

Investigator Site #8019

Seoul, 5030, South Korea

Location

Investigator Site #8012

Seoul, 6273, South Korea

Location

Investigator Site #4013

A Coruña, 15006, Spain

Location

Investigator Site #4008

Alicante, 3699, Spain

Location

Investigator Site #4007

Barcelona, 8035, Spain

Location

Investigator Site #4002

Seville, 41014, Spain

Location

Investigator Site #4009

Valencia, 46010, Spain

Location

Investigator Site #8013

Chiayi City, 622, Taiwan

Location

Investigator Site #8014

Kaohsiung City, 11490, Taiwan

Location

Investigator Site #8008

Taichung, 40201, Taiwan

Location

Investigator Site #8015

Taichung, 40447, Taiwan

Location

Investigator Site #8017

Taipei, 100, Taiwan

Location

Investigator Site #4017

Leeds, LS1 3EX, United Kingdom

Location

Investigator Site #4015

London, NW1 2BU, United Kingdom

Location

Investigator Site #4016

London, SE1 7RT, United Kingdom

Location

Investigator Site #4014

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 28, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); IN (16); RO (3); CO (7); GB (4); ME (16); KR (5); CR (2); BU (7); CL (2); ES (5); PH (7); TW (5); DK (2); PE (5); US (48); PL (14); PR (2); AR (8); DE (3); HU (2)