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ESK-001 for Lupus (LUMUS Trial)
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.
LUMUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLUMUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LUMUS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: ESK-001 Dose Level 2
- Group 2: ESK-001 Dose Level 1
- Group 3: Placebo
- Group 4: ESK-001 Dose Level 3
- 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
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."
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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