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Corticosteroid
PRV-3279 for Lupus (PREVAIL-2 Trial)
Phase 2
Waitlist Available
Research Sponsored by Provention Bio, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has moderate to severe disease activity despite stable standard-of-care medication
Be older than 18 years old
Must not have
Participation in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product
Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights
Summary
This trial is testing a drug to see if it can prevent flares in people with lupus who are in remission.
Who is the study for?
This trial is for people who've had systemic lupus erythematosus (SLE) for at least 6 months and meet specific criteria showing active disease despite treatment. They must have improved after steroids before joining, can't be on certain other lupus treatments, and should not have severe kidney or brain SLE symptoms, recent serious infections, COVID-19 recently, or been in another study or received certain vaccines too close to the start of this trial.
What is being tested?
The PREVAIL-2 study is testing PRV-3279 against a placebo to see if it can prevent flares in SLE patients whose symptoms got better with corticosteroids. Participants will either receive PRV-3279 or a placebo without knowing which one they're getting.
What are the potential side effects?
Possible side effects of PRV-3279 are not detailed here but generally could include reactions where the drug is given, increased risk of infection due to immune system changes, fatigue, headaches, and potential unknown risks as it's being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is still severe despite taking my regular medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't been in a drug study for at least 42 days or five half-lives of the drug.
Select...
I have a significant immune system disorder.
Select...
I have active kidney issues or brain symptoms due to lupus.
Select...
I haven't taken any biologic treatments like TNF inhibitors or interleukin antagonists in the last 42 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the ability of PRV-3279 to prevent flare, defined by LFA international consensus definition of flare, worsening on CGIC, and increase in hSLEDAI/BILAG scores
Secondary study objectives
To evaluate the safety of PRV-3279
To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids
Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Sterile solution for intravenous administration, every 4 weeks
Group II: PRV-3279Experimental Treatment1 Intervention
Sterile solution for intravenous administration, every 4 weeks
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Who is running the clinical trial?
Provention Bio, a Sanofi CompanyLead Sponsor
4 Previous Clinical Trials
440 Total Patients Enrolled
Provention Bio, Inc.Lead Sponsor
10 Previous Clinical Trials
1,246 Total Patients Enrolled
Chief Medical Officer, MDStudy DirectorProvention Bio, Inc.
22 Previous Clinical Trials
7,266 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: PRV-3279
- Group 2: Placebo
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.
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