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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
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36 up to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 up to week 48
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 moreOther study objectives
Number of Participants who experience AEs, SAEs, AESIs
Side effects data
From 2023 Phase 2 trial • 214 Patients • NCT0492593413%
COVID-19
11%
Urinary tract infection
6%
Upper respiratory tract infection bacterial
6%
Dyspepsia
3%
Influenza
3%
Diarrhoea
3%
Sinusitis
3%
Nasopharyngitis
1%
Ischaemic stroke
1%
Loss of consciousness
1%
Headache
1%
Hydrosalpinx
1%
Hiatus hernia
1%
Acute myocardial infarction
1%
Abdominal hernia
1%
Osteoarthritis
1%
Huntington's disease
1%
Pneumonia
1%
Abortion induced incomplete
1%
Hyponatraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daxdilimab 200mg Q12W
Placebo
Daxdilimab 200mg Q4W
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
1,427 Previous Clinical Trials
1,384,521 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
732 Total Patients Enrolled
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