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SLEPhase 2LUMUSNCT05966480

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

A Phase 2 study testing Envudeucitinib in people with SLE, run by Alumis Inc at 169 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
SLE
What is being tested?
Envudeucitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
169 sitesin 21 countries
Study dates
26 Jun 2023to 1 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

169 sites in 21 countries.

169 sites in 21 countries

United States48 sites

  • Investigator Site #1101

    Albuquerque, New Mexico, 87102

  • Investigator Site #1046

    Anniston, Alabama, 36207

  • Investigator Site #1170

    Atlanta, Georgia, 30328

  • Investigator Site #1048

    Aventura, Florida, 33180

  • Investigator Site #1063

    Avon Park, Florida, 33825

  • Investigator Site #1176

    Bradenton, Florida, 34209

  • Investigator Site #1058

    Brooklyn, New York, 11201

  • Investigator Site #1195

    Carrollton, Texas, 75006

  • Investigator Site #1095

    Charlotte, North Carolina, 28207

  • Investigator Site #1056

    Charlotte, North Carolina, 28210

  • Investigator Site #1173

    Charlotte, North Carolina, 28277

  • Investigator Site #1204

    Chesterfield, Missouri, 63017

  • Investigator Site #1045

    Clearwater, Florida, 33765

  • Investigator Site #1052

    College Park, Georgia, 30329

  • Investigator Site #1049

    Colleyville, Texas, 76034

  • Investigator Site #1055

    Coral Gables, Florida, 33134

  • Investigator Site #1097

    Coral Springs, Florida, 33071

  • Investigator Site #1091

    Daytona Beach, Florida, 32117

  • Investigator Site #1051

    DeBary, Florida, 32713

  • Investigator Site #1071

    Fort Worth, Texas, 76177

  • Investigator Site #1087

    Hollywood, Florida, 33020

  • Investigator Site #1094

    Houston, Texas, 77054

  • Investigator Site #1169

    Houston, Texas, 77095

  • Investigator site #1178

    Houston, Texas, 77386

  • Investigator Site #1135

    Kissimmee, Florida, 34741

  • Investigator Site #1104

    La Jolla, California, 92037

  • Investigator site #1209

    Las Vegas, Nevada, 89102

  • Investigator Site #1050

    Los Alamitos, California, 90720

  • Investigator Site #1044

    Memphis, Tennessee, 38119

  • Investigator Site #1060

    Miami, Florida, 33136

  • Investigator Site #1093

    Miami, Florida, 33155

  • Investigator Site #1057

    Miami, Florida, 33176

  • Investigator Site #1067

    Miami Lakes, Florida, 33014

  • Investigator Site #1168

    Mission Hills, California, 91345

  • Investigator Site #1174

    Napa, California, 94558

  • Investigator Site #1088

    New York, New York, 10032

  • Investigator Site #1171

    Philadelphia, Pennsylvania, 19114

  • Investigator Site #1062

    Pittsburgh, Pennsylvania, 15224

  • Investigator Site #1090

    Plantation, Florida, 33324

  • Investigator Site #1175

    Queens, New York, 11001

  • Investigator Site #1187

    Red Oak, Texas, 75154

  • Investigator site #1053

    San Antonio, Texas, 78215

  • Investigator Site #1186

    San Antonio, Texas, 78229

  • Investigator Site #1189

    Sparta, New Jersey, 07871

  • Investigator Site #1172

    Spring, Texas, 77388

  • Investigator Site #1089

    Tampa, Florida, 33606

  • Investigator Site #1194

    Tomball, Texas, 77375

  • Investigator Site #1061

    Upland, California, 91786

Other trials in United States

India16 sites

  • Investigator Site #6005

    Ahmedabad, 380005

  • Investigator Site #6010

    Ahmedabad, 380006

  • Investigator Site #6016

    Ahmedabad, 380013

  • Investigator Site #6006

    Ahmedabad, 380015

  • Investigator Site #6001

    Bangalore, 560034

  • Investigator Site #6009

    Bengaluru, 560010

  • Investigator Site #6012

    Chandigarh, 160012

  • Investigator Site #6004

    Haryāna, 122001

  • Investigator Site #6013

    Jaipur, 302004

  • Investigator Site #6011

    Lucknow, 226014

  • Investigator Site #6008

    Nagpur, 440012

  • Investigator Site # 6015

    New Delhi, National Capital Territory of Delhi, 110 029

  • Investigator Site #6014

    Pune, 411007

  • Investigator Site #6007

    Pune, 411057

  • Investigator Site #6002

    Surat, 395001

  • Investigator Site #6003

    Surat, 395002

Other trials in India

Mexico16 sites

  • Investigator Site #2501

    Chihuahua City, 31000

  • Investigator Site #2504

    Cuauhtémoc, 6720

  • Investigator Site #2502

    Guadalajara, 44160

  • Investigator Site #2512

    Guadalajara, 44620

  • Investigator Site #2507

    Guadalajara, 44650

  • Investigator Site #2508

    Madero, 7760

  • Investigator Site #2511

    Mérida, 97070

  • Investigator Site #2516

    Mérida, 97070

  • Investigator Site #2509

    Mexico City, 14080

  • Investigator Site #2514

    Mexico City, 3100

  • Investigator Site #2503

    Mexico City, 3720

  • Investigator Site #2506

    Mexico City, 6700

  • Investigator Site # 2517

    Naucalpan, State of Mexico, 54769

  • Investigator Site #2510

    Oaxaca City, 68000

  • Investigator Site #2505

    San Luis Potosí City, 78213

  • Investigator Site #2513

    Torreón, 27000

Other trials in Mexico

Poland14 sites

  • Investigator Site #5519

    Bialystok, 15-077

  • Investigator Site #5546

    Bialystok, 15-297

  • Investigator Site #5518

    Bialystok, 15-707

  • Investigator Site #5531

    Bydgoszcz, 85-168

  • Investigator Site #5520

    Bytom, Bytom, 41-902

  • Investigator Site #5539

    Częstochowa, 42-200

  • Investigator Site #5533

    Krakow, 30-363

  • Investigator Site #5537

    Nadarzyn, 05-830

  • Investigator Site #5545

    Poznan, 61-397

  • Investigator Site #5535

    Sosnowiec, 41-200

  • Investigator Site #5532

    Szczecin, 71-252

  • Investigator Site #5527

    Warsaw, 00-215

  • Investigator Site #5540

    Warsaw, 02-637

  • Investigator Site #5528

    Wroclaw, 50-088

Other trials in Poland

Argentina8 sites

  • Investigator Site #3023

    Buenos Aires, Buenos Aires, C1114 AAH

  • Investigator Site #3012

    CABA, Buenos Aires, C1425

  • Investigator Site #3001

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1221ADC

  • Investigator Site #3016

    La Plata, Buenos Aires, B1900

  • Investigator Site #3008

    Mendoza, Mendoza Province, M5500CPH

  • Investigator Site #3009

    San Miguel de Tucumán, Tucman, T4000BRD

  • Investigator Site #3010

    San Miguel de Tucumán, Tucman, T4000BRD

  • Investigator Site #3015

    San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Bulgaria7 sites

  • Investigator Site #5603

    Haskovo, 6300

  • Investigator Site #5602

    Pleven, 2873

  • Investigator Site #5525

    Plovdiv, 4003

  • Investigator Site #5521

    Plovdiv

  • Investigator Site #5529

    Rousse, 7002

  • Investigator Site #5522

    Sofia, 1407

  • Investigator Site #5547

    Sofia, 1463

Other trials in Bulgaria

Colombia7 sites

  • Investigator Site #3019

    Barranquilla, 11111

  • Investigator Site #3011

    Barranquilla, 80020

  • Investigator Site #3021

    Bogotá, 110221

  • Investigator Site #3022

    Bogotá, 504

  • Investigator Site #3020

    Cali, 760035

  • Investigator Site #3003

    Chía, 250001

  • Investigator Site #3014

    Medellín, 50034

Other trials in Colombia

Philippines7 sites

  • Investigator Site #8003

    Angeles City

  • Investigator Site #8009

    Iloilo City

  • Investigator Site #8011

    Lipa City

  • Investigator Site #8001

    Manila

  • Investigator Site #8010

    Manila

  • Investigator Site #8018

    Manila

  • Investigator Site #8006

    Quezon City

Other trials in Philippines

Georgia6 sites

  • Investigator Site #5516

    Tbilisi, 0168

  • Investigator Site #5523

    Tbilisi, 102

  • Investigator Site #5538

    Tbilisi, 112

  • Investigator Site #5536

    Tbilisi, 114

  • Investigator Site #5534

    Tbilisi, 180

  • Investigator Site #5517

    Tbilisi

Other trials in Georgia

Peru5 sites

  • Investigator Site #3013

    Lima, 15047

  • Investigator Site #3004

    Lima, 15801

  • Investigator Site #3018

    San Martín de Porres, 15102

  • Investigator Site #3005

    Santiago de Surco, 15023

  • Investigator Site #3017

    Trujillo, 13001

Other trials in Peru

South Korea5 sites

  • Investigator Site #8007

    Anyang-si, 14068

  • Investigator Site #8004

    Busan, 49241

  • Investigator Site #8016

    Seoul, 3080

  • Investigator Site #8019

    Seoul, 5030

  • Investigator Site #8012

    Seoul, 6273

Other trials in South Korea

Spain5 sites

  • Investigator Site #4013

    A Coruña, 15006

  • Investigator Site #4008

    Alicante, 3699

  • Investigator Site #4007

    Barcelona, 8035

  • Investigator Site #4002

    Seville, 41014

  • Investigator Site #4009

    Valencia, 46010

Other trials in Spain

Taiwan5 sites

  • Investigator Site #8013

    Chiayi City, 622

  • Investigator Site #8014

    Kaohsiung City, 11490

  • Investigator Site #8008

    Taichung, 40201

  • Investigator Site #8015

    Taichung, 40447

  • Investigator Site #8017

    Taipei, 100

Other trials in Taiwan

United Kingdom4 sites

  • Investigator Site #4017

    Leeds, LS1 3EX

  • Investigator Site #4015

    London, NW1 2BU

  • Investigator Site #4016

    London, SE1 7RT

  • Investigator Site #4014

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany3 sites

  • Investigator Site #4003

    Leipzig, 4103

  • Investigator Site #4005

    Mainz, 55131

  • Investigator Site #4006

    Munich, 80336

Other trials in Germany

Romania3 sites

  • Investigator Site #5530

    Bucharest, 11025

  • Investigator Site #5549

    Bucharest, 11057

  • Investigator Site #5526

    Bucharest, 11172

Other trials in Romania

Chile2 sites

  • Investigator Site #3006

    Providencia, 7510586

  • Investigator Site #3002

    Santiago, 75500587

Other trials in Chile

Croatia2 sites

  • Investigator Site #5542

    Rijeka, 51000

  • Investigator Site #5543

    Split, 21000

Other trials in Croatia

Denmark2 sites

  • Investigator Site #4012

    Aarhus

  • Investigator Site #4011

    Køge, 4600

Other trials in Denmark

Hungary2 sites

  • Investigator Site #5548

    Debrecen, 4032

  • Investigator Site #5544

    Gyula

Other trials in Hungary

Puerto Rico2 sites

  • Investigator site #3028

    Caguas, 00725

  • Investigator site #3029

    San Juan, 00909-1908

Other trials in Puerto Rico

About this study

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

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.

Read the detailed 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.

Conditions
SLE
Being tested
Envudeucitinib, Placebo
Keywords
Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, SLE, Lupus, LUMUS, Lupus Erythematosus, Systemic
Medical subject headings
Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvudeucitinibDrug

    Oral tablet

  • PlaceboDrug

    Oral tablet

Study groups in NCT05966480
Study groupRoleWhat they receive
ESK-001 Dose Level 1ExperimentalESK-001 administered as an oral tablet
Receives: Drug: Envudeucitinib
ESK-001 Dose Level 2ExperimentalESK-001 administered as an oral tablet
Receives: Drug: Envudeucitinib
ESK-001 Dose Level 3ExperimentalESK-001 administered as an oral tablet
Receives: Drug: Envudeucitinib
PlaceboPlacebo comparatorPlacebo administered as an oral tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 48

Secondary outcomes (14)

  1. 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.

    Measured: Week 48

  2. 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

    Measured: Week 48

  3. 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.

    Measured: Week 48

  4. 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

    Measured: Week 48

  5. 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

    Measured: Week 48

  6. To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48

    Measured: Week 48

  7. To compare the annualized flare rate through Week 48

    Measured: Week 48

  8. 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.

    Measured: Week 48

  9. 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.

    Measured: Week 48

  10. 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.

    Measured: Week 48

  11. 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).

    Measured: Week 48

  12. 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).

    Measured: Week 48

  13. 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.

    Measured: Week 48

  14. 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.

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start26 Jun 2023
  3. Primary completion23 Jun 2026
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966480
Sponsor's protocol ID
ESK-001-010
Acronym
LUMUS
Status last verified
Jul 2026
First submitted
29 Jun 2023
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envudeucitinib in people with SLE, run by Alumis Inc at 169 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, India, Mexico, Poland, Argentina and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05966480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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