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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

PREVAIL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is still severe despite taking my regular medication.

PREVAIL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
To evaluate the safety of PRV-3279
To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids

PREVAIL-2 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

Find a Location

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
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,739 Total Patients Enrolled

Media Library

Corticosteroid (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05087628 — Phase 2
Lupus Research Study Groups: PRV-3279, Placebo
Lupus Clinical Trial 2023: Corticosteroid Highlights & Side Effects. Trial Name: NCT05087628 — Phase 2
Corticosteroid (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087628 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Is this medical trial accommodating seniors in its participant criteria?

"Candidates eligible for this trial must fall between 18 and 70 years of age."

Answered by AI

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),"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PRV-3279-2a Trial in Systemic Lupus
2022. "PRV-3279-2a Trial in Systemic Lupus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05087628.
All > Systemic Lupus Erythematosus > Lupus
~37 spots leftby Sep 2025
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