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PRV-3279 for Lupus (PREVAIL-2 Trial)
PREVAIL-2 Trial Summary
This trial is testing a drug to see if it can prevent flares in people with lupus who are in remission.
PREVAIL-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPREVAIL-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PREVAIL-2 Trial Design
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Who is running the clinical trial?
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- I haven't taken antibiotics in the last 2 weeks or been hospitalized for an infection in the last month.I haven't been in a drug study for at least 42 days or five half-lives of the drug.My condition is still severe despite taking my regular medication.Nothing will stop me from following the study's required checks.I haven't had B-cell depleting treatments like rituximab in the last 6 months, or my B cells have returned to normal since then.I have not had certain immune treatments or high-dose steroids recently.I have a significant immune system disorder.I haven't had a live vaccine in the last 2 months or any vaccine in the last 2 weeks.I have been diagnosed with SLE for at least 6 months.I do not have any autoimmune diseases that could affect treatment results.I have active kidney issues or brain symptoms due to lupus.I have had COVID-19 or tested positive for it in the last 4 weeks.I am willing to stop all my lupus treatments except for antimalarials, low-dose steroids, and NSAIDs.I haven't taken any biologic treatments like TNF inhibitors or interleukin antagonists in the last 42 days.
- Group 1: PRV-3279
- Group 2: Placebo
- 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
What potential risks could arise from using PRV-3279 as a therapeutic?
"Our risk assessment gave PRV-3279 a score of 2 due to the lack of efficacy data, although there is some evidence for safety."
Is this medical trial accommodating seniors in its participant criteria?
"Candidates eligible for this trial must fall between 18 and 70 years of age."
Could I be accepted to join this clinical trial?
"This clinical study is accepting 100 adults, aged 18-70, that meet the safety and efficacy criteria. Patients must present with a high SLEDAI score of 6 or greater at screening (4 points from non-serological findings) and demonstrate ≥ 4 point reduction in hSLEDAI, OR an improvement of one BILAG letter grade for any A or B scores detected at Screening with investigator/central adjudication committee rating as definite/major/complete improvement. Additionally, participants need to be willing to cease all lupus treatments aside from antimalarials, corticosteroids (< 10 mg prednisone equivalent),"
How many participants are currently participating in this research experiment?
"Affirmative. The information on clinicaltrials.gov confirms that this medical trial is accepting participants. This study was first posted to the platform on January 24th 2022 and has since been revised, with its latest edit being made on November 14th 2022. A total of 100 individuals are needed for 10 distinct sites involved in the project."
In what areas is this experimental investigation taking place?
"This clinical trial is now taking place at 10 dispersed medical centres, including Tujunga, Tamarac and Whittier. To minimize any inconvenience of travel for participants, it's recommended to enroll in the closest clinic possible."
Are there any vacancies left for enrollees in this research?
"Affirmative. The information held on clinicaltrials.gov attests that this experiment is presently recruiting participants, having been initially posted on January 24th 2022 and recently refreshed on November 14th 2022. 100 patients must be enrolled from 10 different medical centres."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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