Study Complete
Sponsor ID
VIB7734.P2.S1

Study of VIB7734 for the Treatment of Moderate to Severely Active SLERECAST SLE

Sponsor ID
VIB7734.P2.S1
Clinicaltrials.gov ID
NCT04925934
EUCTIS ID
N/A
EudraCT ID
2020-005528-12

Study Details

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
214
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48

Timeframe: Week 48

Secondary Outcome Measures

Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12

Timeframe: Week 12

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

Timeframe: 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

Timeframe: Week 36 to Week 48

Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48

Timeframe: Week 48

Locations

Location
Status
Contact Us
Location
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Status
Withdrawn
Location
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States, 91786
Status
Completed
Location
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States, 33765-2616
Status
Completed
Location
Millennium Research
Ormond Beach, Florida, United States, 32174
Status
Completed
Location
IRIS Research and Development LLC
Plantation, Florida, United States, 33324
Status
Completed
Location
Clinical Research of West Florida Inc – Tampa
Tampa, Florida, United States, 33606-1246
Status
Completed
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