ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-06-26
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05966480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
  3. * And/or no more than 1 of the following conventional DMARDS:
  4. * Azathioprine ≤200 mg/day
  5. * Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
  6. * Oral, subcutaneous, or intramuscular (IM) methotrexate ≤20 mg/week.
  1. * Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments
  2. * Active, proliferative lupus nephritis that in the Investigator's opinion may require treatment not allowed by the protocol
  3. * 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.
  4. * 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.
  5. * That would make the patient unable to fully understand the ICF, or
  6. * 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
  7. * Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection
  8. * Currently active, clinically significant infection of any kind
  9. * Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF (chronic fungal nail infections are allowed)
  10. * Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF
  11. * Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
  12. * 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)
  13. * Active herpes zoster infection within 12 weeks of prior to signing the ICF
  14. * Active herpes simplex virus within 4 weeks of Day 1
  15. * Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Study Locations (Sites)

Investigator Site #1046
Anniston, Alabama, 36207
United States
Investigator Site #1104
La Jolla, California, 92037
United States
Investigator Site #1050
Los Alamitos, California, 90720
United States
Investigator Site #1168
Mission Hills, California, 91345
United States
Investigator Site #1174
Napa, California, 94558
United States
Investigator Site #1061
Upland, California, 91786
United States
Investigator Site #1048
Aventura, Florida, 33180
United States
Investigator Site #1063
Avon Park, Florida, 33825
United States
Investigator Site #1176
Bradenton, Florida, 34209
United States
Investigator Site #1045
Clearwater, Florida, 33765
United States
Investigator Site #1055
Coral Gables, Florida, 33134
United States
Investigator Site #1097
Coral Springs, Florida, 33071
United States
Investigator Site #1091
Daytona Beach, Florida, 32117
United States
Investigator Site #1051
DeBary, Florida, 32713
United States
Investigator Site #1087
Hollywood, Florida, 33020
United States
Investigator Site #1135
Kissimmee, Florida, 34741
United States
Investigator Site #1067
Miami Lakes, Florida, 33014
United States
Investigator Site #1060
Miami, Florida, 33136
United States
Investigator Site #1093
Miami, Florida, 33155
United States
Investigator Site #1057
Miami, Florida, 33176
United States
Investigator Site #1090
Plantation, Florida, 33324
United States
Investigator Site #1089
Tampa, Florida, 33606
United States
Investigator Site #1170
Atlanta, Georgia, 30328
United States
Investigator Site #1052
College Park, Georgia, 30329
United States
Investigator Site #1204
Chesterfield, Missouri, 63017
United States
Investigator site #1209
Las Vegas, Nevada, 89102
United States
Investigator Site #1189
Sparta, New Jersey, 07871
United States
Investigator Site #1101
Albuquerque, New Mexico, 87102
United States
Investigator Site #1058
Brooklyn, New York, 11201
United States
Investigator Site #1088
New York, New York, 10032
United States
Investigator Site #1175
Queens, New York, 11001
United States
Investigator Site #1095
Charlotte, North Carolina, 28207
United States
Investigator Site #1056
Charlotte, North Carolina, 28210
United States
Investigator Site #1173
Charlotte, North Carolina, 28277
United States
Investigator Site #1171
Philadelphia, Pennsylvania, 19114
United States
Investigator Site #1062
Pittsburgh, Pennsylvania, 15224
United States
Investigator Site #1044
Memphis, Tennessee, 38119
United States
Investigator Site #1195
Carrollton, Texas, 75006
United States
Investigator Site #1049
Colleyville, Texas, 76034
United States
Investigator Site #1071
Fort Worth, Texas, 76177
United States
Investigator Site #1094
Houston, Texas, 77054
United States
Investigator Site #1169
Houston, Texas, 77095
United States
Investigator site #1178
Houston, Texas, 77386
United States
Investigator Site #1187
Red Oak, Texas, 75154
United States
Investigator site #1053
San Antonio, Texas, 78215
United States
Investigator Site #1186
San Antonio, Texas, 78229
United States
Investigator Site #1172
Spring, Texas, 77388
United States
Investigator Site #1194
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: Alumis Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2023-06-26
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • SLE