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Monoclonal Antibodies

VIB7734 for Systemic Lupus Erythematosus (RECAST SLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Viela Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36 up to week 48

Summary

This trial is testing a new drug called VIB7734 to help people with severe lupus. The drug aims to reduce the harmful activity of the immune system that causes damage in lupus patients. The study will include nearly 200 participants.

Eligible Conditions
  • Systemic Lupus Erythematosus
  • Lupus

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48
Secondary study objectives
Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48
Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48
Number of Participants Who Experienced AEs of Special Interest (AESI)
+4 more
Other study objectives
Number of Participants who experience AEs, SAEs, AESIs

Side effects data

From 2023 Phase 2 trial • 214 Patients • NCT04925934
14%
COVID-19
10%
Urinary tract infection
6%
Sinusitis
6%
Diarrhoea
6%
Palpitations
6%
Influenza
4%
Headache
4%
Nasopharyngitis
1%
Peripheral artery occlusion
1%
Angina pectoris
1%
Ischaemic cardiomyopathy
1%
Pericardial effusion
1%
Cholelithiasis
1%
Herpes zoster
1%
Upper respiratory tract infection bacterial
1%
Duodenal ulcer haemorrhage
1%
Uterine polyp
1%
Pneumonia
1%
Systemic lupus erythematosus
1%
Pulmonary embolism
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daxdilimab 200mg Q4W
Placebo
Daxdilimab 200mg Q12W

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
2021
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Viela BioLead Sponsor
12 Previous Clinical Trials
890 Total Patients Enrolled
AmgenLead Sponsor
1,434 Previous Clinical Trials
1,395,622 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
732 Total Patients Enrolled
~48 spots leftby Nov 2025
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