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

Primary Purpose

SLE

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ESK-001
Placebo
Sponsored by
Alumis Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SLE focused on measuring Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, SLE, Lupus, LUMUS, Lupus Erythematosus, Systemic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site #1046Recruiting
  • Investigator Site #1050Recruiting
  • Investigator Site #1061
  • Investigator Site #1048Recruiting
  • Investigator Site #1063
  • Investigator Site #1045Recruiting
  • Investigator Site #1055Recruiting
  • Investigator Site #1051Recruiting
  • Investigator Site # 1067
  • Investigator Site #1060
  • Investigator Site #1057Recruiting
  • Investigator Site #1052Recruiting
  • Investigator Site #1058
  • Investigator Site #1056Recruiting
  • Investigator Site #1062
  • Investigator Site #1044Recruiting
  • Investigator Site #1049Recruiting
  • Investigator Site #1071
  • Investigator Site #3012
  • Investigator Site #3001
  • Investigator Site #3016
  • Investigator Site #3009
  • Investigator Site #3010
  • Investigator Site #3015
  • Investigator Site #3023
  • Investigator Site #3008
  • Investigator Site #5525
  • Investigator Site #5521
  • Investigator Site #5529
  • Investigator Site #5522
  • Investigator Site #5547
  • Investigator Site #5541
  • Investigator Site #3006
  • Investigator Site #3002
  • Investigator Site #3019
  • Investigator Site #3011
  • Investigator Site #3021
  • Investigator Site #3022
  • Investigator Site #3020
  • Investigator Site #3003
  • Investigator Site #3014
  • Investigator Site #5542
  • Investigator Site #5543
  • Investigator Site #4012
  • Investigator Site #4011
  • Investigator Site #5516
  • Investigator Site #5523
  • Investigator Site #5538
  • Investigator Site #5536
  • Investigator Site #5534
  • Investigator Site #4010
  • Investigator Site #4001
  • Investigator Site #4004
  • Investigator Site #4003
  • Investigator Site #4005
  • Investigator Site #4006
  • Investigator Site #5548
  • Investigator Site #5544
  • Investigator Site # 6015
  • Investigator Site #6005
  • Investigator Site #6010
  • Investigator Site #6006
  • Investigator Site #6001
  • Investigator Site #6009
  • Investigator Site #6012
  • Investigator Site #6004
  • Investigator Site #6013
  • Investigator Site #6011
  • Investigator Site #6008
  • Investigator Site #6014
  • Investigator Site #6007
  • Investigator Site #6002
  • Investigator Site #6003
  • Investigator Site #8002
  • Investigator Site #8007
  • Investigator Site #8004
  • Investigator Site #8016
  • Investigator Site #8019
  • Investigator Site #8012
  • Investigator Site #2501
  • Investigator Site #2509
  • Investigator Site #2503
  • Investigator Site #2506
  • Investigator Site #2504
  • Investigator Site #2502
  • Investigator Site #2512
  • Investigator Site #2507
  • Investigator Site #2508
  • Investigator Site #2516
  • Investigator Site #2514
  • Investigator Site #2511
  • Investigator Site # 2517
  • Investigator Site #2510
  • Investigator Site #2505
  • Investigator Site #2513
  • Investigator Site #3013
  • Investigator Site #3004
  • Investigator Site #3018
  • Investigator Site #3005
  • Investigator Site #3017
  • Investigator Site #8003
  • Investigator Site #8009
  • Investigator Site #8011
  • Investigator Site #8001
  • Investigator Site #8010
  • Investigator Site #8018
  • Investigator Site #8006
  • Investigator Site #5519
  • Investigator Site #5546
  • Investigator Site #5518
  • Investigator Site #5531
  • Investigator Site #5520
  • Investigator Site #5539
  • Investigator Site #5533
  • Investigator Site #5537
  • Investigator Site #5545
  • Investigator Site #5535
  • Investigator Site #5532
  • Investigator Site #5527
  • Investigator Site #5540
  • Investigator Site #5528
  • Investigator Site #5530
  • Investigator Site #5549
  • Investigator Site #5526
  • Investigator Site #5524
  • Investigator Site #4013
  • Investigator Site #4008
  • Investigator Site #4007
  • Investigator Site #4002
  • Investigator Site #4009
  • Investigator Site #8013
  • Investigator Site #8014
  • Investigator Site #8008
  • Investigator Site #8015
  • Investigator Site #8017
  • Investigator Site #4017
  • Investigator Site #4015
  • Investigator Site #4016
  • Investigator Site #4014

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ESK-001 Dose Level 1

ESK-001 Dose Level 2

ESK-001 Dose Level 3

Placebo

Arm Description

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

ESK-001 administered as an oral tablet

Placebo administered as an oral tablet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2023
Last Updated
July 21, 2023
Sponsor
Alumis Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05966480
Brief Title
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
Acronym
LUMUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alumis Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SLE
Keywords
Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, SLE, Lupus, LUMUS, Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESK-001 Dose Level 1
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 2
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
ESK-001 Dose Level 3
Arm Type
Experimental
Arm Description
ESK-001 administered as an oral tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as an oral tablet
Intervention Type
Drug
Intervention Name(s)
ESK-001
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of multiple dose levels of ESK-001
Description
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.
Time Frame
Week 48
Title
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
Time Frame
Week 48
Title
To compare corticosteroid use in patients at Week 48
Description
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.
Time Frame
Week 48
Title
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
Time Frame
Week 48
Title
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
Time Frame
Week 48
Title
To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48
Time Frame
Week 48
Title
To compare the annualized flare rate through Week 48
Time Frame
Week 48
Title
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
Description
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.
Time Frame
Week 48
Title
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
Description
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.
Time Frame
Week 48
Title
To compare disease-specific QoL between doses of ESK-001 and placebo
Description
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.
Time Frame
Week 48
Title
To compare disease-specific QoL between doses of ESK-001 and placebo
Description
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).
Time Frame
Week 48
Title
To compare disease-specific QoL between doses of ESK-001 and placebo
Description
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).
Time Frame
Week 48
Title
To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo
Description
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.
Time Frame
Week 48
Title
To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo
Description
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.
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central Recruiting
Phone
(+1) 650-538-2502
Email
clinicaltrials@alumis.com
Facility Information:
Facility Name
Investigator Site #1046
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1050
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1061
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1048
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1063
City
Avon Park
State/Province
Florida
ZIP/Postal Code
33825
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1045
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1055
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1051
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site # 1067
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1060
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1057
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1052
City
College Park
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1058
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1056
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1062
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #1044
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1049
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigator Site #1071
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3012
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3001
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3016
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3009
City
San Miguel de Tucuman
State/Province
Tucman
ZIP/Postal Code
T4000BRD
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3010
City
San Miguel De Tucumán
State/Province
Tucman
ZIP/Postal Code
T4000BRD
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3015
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3023
City
Buenos Aires
ZIP/Postal Code
C1114 AAH
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3008
City
Mendoza
ZIP/Postal Code
M5500CPH
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5525
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5521
City
Plovdiv
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5529
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5522
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5547
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5541
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3006
City
Providencia
ZIP/Postal Code
7510586
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3002
City
Santiago
ZIP/Postal Code
75500587
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3019
City
Barranquilla
ZIP/Postal Code
11111
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3011
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3021
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3022
City
Bogotá
ZIP/Postal Code
504
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3020
City
Cali
ZIP/Postal Code
760035
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3003
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3014
City
Medellín
ZIP/Postal Code
50034
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5542
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5543
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4012
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4011
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5516
City
Tbilisi
ZIP/Postal Code
0168
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5523
City
Tbilisi
ZIP/Postal Code
102
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5538
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5536
City
Tbilisi
ZIP/Postal Code
114
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5534
City
Tbilisi
ZIP/Postal Code
180
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4010
City
Bad Bramstedt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4001
City
Kirchheim Unter Teck
ZIP/Postal Code
73230
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4004
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4003
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4005
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4006
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5548
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5544
City
Gyula
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site # 6015
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 029
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6005
City
Ahmedabad
ZIP/Postal Code
380005
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6010
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6006
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6001
City
Bangalore
ZIP/Postal Code
560034
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6009
City
Bengaluru
ZIP/Postal Code
560010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6012
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6004
City
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6013
City
Jaipur
ZIP/Postal Code
302004
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6011
City
Lucknow
ZIP/Postal Code
226014
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6008
City
Nagpur
ZIP/Postal Code
440012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6014
City
Pune
ZIP/Postal Code
411007
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6007
City
Pune
ZIP/Postal Code
411057
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6002
City
Surat
ZIP/Postal Code
395001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #6003
City
Surat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8002
City
Namdong
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8007
City
Anyang-si
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8004
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8016
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8019
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8012
City
Seoul
ZIP/Postal Code
6273
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2501
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2509
City
Ciudad de Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2503
City
Ciudad de Mexico
ZIP/Postal Code
3720
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2506
City
Ciudad De Mexico
ZIP/Postal Code
6700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2504
City
Cuauhtémoc
ZIP/Postal Code
6720
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2502
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2512
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2507
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2508
City
Madero
ZIP/Postal Code
7760
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2516
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2514
City
Mexico City
ZIP/Postal Code
3100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2511
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site # 2517
City
Naucalpan De Juárez
ZIP/Postal Code
54769
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2510
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2505
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #2513
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3013
City
Lima
ZIP/Postal Code
15047
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3004
City
Lima
ZIP/Postal Code
15801
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3018
City
San Martin De Porres
ZIP/Postal Code
15102
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3005
City
Santiago De Surco
ZIP/Postal Code
15023
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #3017
City
Trujillo
ZIP/Postal Code
13001
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8003
City
Angeles City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8009
City
Iloilo City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8011
City
Lipa City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8001
City
Manila
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8010
City
Manila
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8018
City
Manila
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8006
City
Quezon City
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5519
City
Bialystok
ZIP/Postal Code
15-077
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5546
City
Białystok
ZIP/Postal Code
15-297
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5518
City
Białystok
ZIP/Postal Code
15-707
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5531
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5520
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5539
City
Częstochowa
ZIP/Postal Code
42-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5533
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5537
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5545
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5535
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5532
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5527
City
Warsaw
ZIP/Postal Code
00-215
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5540
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5528
City
Wrocław
ZIP/Postal Code
50-088
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5530
City
Bucuresti
ZIP/Postal Code
11025
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5549
City
Bucuresti
ZIP/Postal Code
11057
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5526
City
Bucuresti
ZIP/Postal Code
11172
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #5524
City
Târgu-Mureş
ZIP/Postal Code
540096
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4013
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4008
City
Alicante
ZIP/Postal Code
3699
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4007
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4002
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4009
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8013
City
Chiayi City
ZIP/Postal Code
622
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8014
City
Kaohsiung City
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8008
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8015
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #8017
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4017
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4015
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4016
City
London
ZIP/Postal Code
SE1 7RT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Investigator Site #4014
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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