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Monoclonal Antibodies

VIB7734 for Systemic Lupus Erythematosus (RECAST SLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease duration of at least 6 months
Ongoing treatment for SLE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36 to week 48
Awards & highlights

RECAST SLE Trial Summary

This trial is testing a new drug for lupus in 195 people. It will last 48 weeks, with safety follow-up for 8 more weeks. There will be 3 groups, 2 taking the drug and 1 taking placebo.

RECAST SLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had the disease for at least 6 months.
Select...
You are currently receiving treatment for systemic lupus erythematosus (SLE).

RECAST SLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48
Secondary outcome measures
Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48
Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48
Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48
+1 more
Other outcome measures
Number of Participants who experience AEs, SAEs, AESIs

RECAST SLE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB7734 SC (dosing interval 2)Experimental Treatment1 Intervention
Group II: VIB7734 SC (dosing interval 1)Experimental Treatment1 Intervention
Group III: Placebo SC (dosing interval 3)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIB7734
2018
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,857 Total Patients Enrolled
Viela BioLead Sponsor
12 Previous Clinical Trials
915 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
757 Total Patients Enrolled

Frequently Asked Questions

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

Are there any documented cases of people being harmed by VIB7734?

"VIB7734's safety was given a score of 2 by our analysts. This is due to the lack of data supporting efficacy, which is typical for medications in Phase 2 clinical trials."

Answered by AI

To be eligible for this experiment, what are the required qualifications?

"This study is open to 214 patients that have been diagnosed with libman-sacks disease. The participants must be between the ages of 18 and 70 and meet the following criteria: Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE, Disease duration of at least 6 months, SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome., SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE"

Answered by AI

Will this research be beneficial for seniors?

"The age range for patients that can enroll in this clinical trial is 18 to 70 years old. However, there are 17 other trials available for minors and 112 research studies open to senior citizens."

Answered by AI

What is the maximum capacity for participants in this clinical trial?

"This study is not currently looking for new participants. It was posted on June 24th, 2021 and updated on August 11th, 2022. For those still interested in taking part in clinical trials, there are 128 other studies enrolling patients with libman-sacks disease and 1 trial involving VIB7734 that are actively searching for volunteers."

Answered by AI

How can people sign up for this research project?

"Unfortunately, this clinical trial is no longer recruiting patients. The study was first posted on June 24th, 2021 and received its last update on August 11th, 2022. However, there are 128 other trials for libman-sacks disease and 1 VIB7734 study that are still looking for participants."

Answered by AI

Are different hospitals in this city trialing this procedure?

"Enrollment for this study is available at 23 sites. Some of these locations include La Jolla, Syracuse and Greensboro. To reduce enrollee burden, please choose the nearest location to you when enrolling in the study."

Answered by AI

What is the VIB7734 research history?

"VIB7734 was first researched in 2021 by Centro de Estudios de Investigacion Basica Y Clinica SC. So far, there have been 18290 completed trials and 1 trial that is still recruiting patients. The majority of these studies are based in La Jolla, California."

Answered by AI

Have other similar trials been conducted in the past?

"VIB7734 was first researched in 2021 by Viela Bio. The initial study, which included 214 participants, occurred that same year. After the successful completion of Phase 2 drug approval in 2021, there is only one current and active study being conducted by Viela Bio."

Answered by AI
~57 spots leftby Mar 2025