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Monoclonal Antibodies
ESK-001 for Lupus (LUMUS Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Alumis Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Azathioprine ≤200 mg/day
Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
LUMUS Trial Summary
This trial tests how safe and effective a new drug is in treating adults with Lupus, and how it works in the body.
Who is the study for?
Adults with active Systemic Lupus Erythematosus (SLE) for at least 6 months, meeting specific disease criteria and on stable medications like Azathioprine or Methotrexate. Excluded are those with chronic infections, other autoimmune diseases that could affect results, recent use of oral anti-infectives, severe unrelated conditions, or a history of significant neuropsychiatric SLE.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of multiple doses of a new drug called ESK-001 against a placebo in adults with SLE. It will compare how well each treatment works and monitor any changes in the disease's activity and severity.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical drug reactions such as nausea, headaches, possible increased risk of infection due to immune system impact by ESK-001. The study aims to identify these side effects.
LUMUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I take 200 mg or less of Azathioprine daily.
Select...
I am taking no more than 2g of mycophenolate mofetil or 1.44g of mycophenolic acid daily.
Select...
I am taking methotrexate, but no more than 20 mg per week.
LUMUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo
To compare corticosteroid use in patients at Week 48
+9 moreLUMUS Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ESK-001 Dose Level 3Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group II: ESK-001 Dose Level 2Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group III: ESK-001 Dose Level 1Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered as an oral tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESK-001
2022
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Alumis IncLead Sponsor
5 Previous Clinical Trials
537 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a stable dose of corticosteroids (≤40 mg/day) for at least 2 weeks.I have had a severe herpes infection before.I have had lupus for over 6 months, with active symptoms and positive tests.I haven't had a serious infection except for nail fungus in the last 8 weeks.I haven't been hospitalized or needed IV antibiotics for an infection in the last 4 weeks.I take 200 mg or less of Azathioprine daily.I have a condition like HIV or have had my spleen removed, which makes me more prone to infections.I am taking no more than 2g of mycophenolate mofetil or 1.44g of mycophenolic acid daily.I am taking or have taken antimalarial medication.I am taking methotrexate, but no more than 20 mg per week.My lupus affects my kidneys and might need treatment not covered by this study.I have an autoimmune condition that might affect the trial's results.I haven't taken any antibiotics or antivirals in the last 2 weeks.I do not have severe conditions like fibromyalgia, osteoarthritis, or heart/lung diseases that could affect my lupus assessments.I have a serious infection right now.I have not had a shingles infection in the last 3 months.I have not had an active herpes outbreak in the last 4 weeks.I am currently receiving treatment.I am taking no more than one standard arthritis medication.I have severe or unstable brain or nerve problems due to lupus.
Research Study Groups:
This trial has the following groups:- Group 1: ESK-001 Dose Level 2
- Group 2: ESK-001 Dose Level 1
- Group 3: Placebo
- Group 4: ESK-001 Dose Level 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I qualify for inclusion in this medical research?
"Patients between 18 and 70 years old with lupus will be eligible to participate in this clinical trial, which is aiming to recruit a total of 388 patients."
Answered by AI
Is there still capacity for patient enrolment in this trial?
"The information posted on clinicaltrials.gov indicates that this medical trial is proactively recruiting participants. It was originally published in June of 2023 and its parameters were most recently adjusted at the end of July, 2023."
Answered by AI
What potential risks are associated with administering ESK-001 Dose Level 1?
"Due to the fact that this Phase 2 trial lacks evidence of ESK-001 Dose Level 1's efficacy, our team at Power has assigned it a safety rating of 2."
Answered by AI
Are elderly individuals being accepted into this experiment?
"Eligible participants of this trial should be between the age range of 18 to 70. Separately, there are 25 trials for minors and 120 specifically targeting older people aged 65 or higher."
Answered by AI
What is the enrollment count for this trial?
"Alumis Inc, the sponsor of this research project, has identified a need for 388 clinically qualified participants. Multiple sites will be involved in its execution — including Investigator Site #1050 located in Los Alamitos, California and Investigator Site #1061 found in Upland, Florida."
Answered by AI
How many geographical locations are housing this research endeavor?
"Recruitment has already started for this medical investigation, with 139 sites participating including Investigator Site #1050 in Los Alamitos, Investigator Site #1061 in Upland, and Investigator Site #1048 in Aventura. Additionally, there are many more locations providing enrollment opportunities."
Answered by AI
Who else is applying?
What site did they apply to?
Investigator Site #1058
Investigator Site #1049
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I’ve tried other medications that do not work and have increased my chances of infection. Would like to try something new.
PatientReceived 1 prior treatment
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