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Deucravacitinib for Lupus (POETYK SLE-1 Trial)
POETYK SLE-1 Trial Summary
This trial tests a new drug to treat active Systemic Lupus Erythematosus (SLE) to see if it's safe and effective. #SLE #clinicaltrial
POETYK SLE-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOETYK SLE-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 220 Patients • NCT04167462POETYK SLE-1 Trial Design
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Who is running the clinical trial?
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- My lupus was caused by medication, not naturally occurring.I have a history of immune system problems.I was diagnosed with Lupus more than 24 weeks ago.I have severe lupus affecting my kidneys that might need strong medication.I do not have autoimmune diseases except for type 1 diabetes, thyroid issues, Celiac, or Sjögren's.I am currently being treated for a chronic infection.I do not have active or severe mental health issues from lupus.I am taking more than one immunosuppressant.I have been on a stable dose of my lupus medication for at least 8 weeks.My lupus is active, with a score of 6 or more, affecting my joints, skin, or causing rash.I do not have conditions like rheumatoid arthritis, scleroderma, or mixed connective tissue disease along with SLE.I have lupus with specific symptoms not counting towards my eligibility score.I have not had a serious infection or needed strong antibiotics in the last month.I have tested positive for specific autoimmune markers.I may be taking a stable dose of corticosteroids, not exceeding 30 mg/day, and it has been stable for at least 2 weeks.
- Group 1: Arm 1: Deucravacitinib
- Group 2: Arm 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Am I eligible to enroll in this research study?
"Up to 490 patients with systemic lupus erythematosus between the ages of 18 and 75 will be admitted into this trial. Eligibility criteria include: a positive ANA reading ≥ 1:80, a SLEDAI-2K score ≥ 6 points, clinical SLEDAI 2K score ≥ 4 points with joint involvement and/or rash, a diagnosis of SLE at least 24 weeks before screening, meeting the 2019 EULAR/ACR classification criteria for SLE, and being on one or more background therapies (immunosuppressant and/or antimalarial) for 12 weeks prior"
Are there any more positions available for test subjects?
"According to the information readily available on clinicaltrials.gov, this trial is no longer looking for patients as of their last update on November 8th, 2022. This study was initially posted on 21/11/2022. Right now, there are 128 other trials that are actively recruiting patients."
Does this research include elderly participants?
"The age requirement for this clinical trial is that patients must be over 18 but under 75 years old."
What is the status of Deucravacitinib's FDA approval?
"We believe that arm 1 of the deucravacitinib clinical trial is safe, as it has received a score of 3. This is due to there being data supporting efficacy and safety from multiple rounds of testing."
Is this trial taking place in more than one urban location?
"With 21 sites available, patients have plenty of options for participating in this study. Some notable locations include the Arthritis & Rheumatology Research Institute in Allen, Yale University School of Medicine in New Haven, and the University of Florida College of Medicine in Gainesville."
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