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NCT04925934 · ClinicalTrials.gov registry record · Phase 2
Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
A Phase 2 study of Lupus Erythematosus, Systemic, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
- 20
- Study locations
NCT04925934: Completed Phase 2 study of Lupus Erythematosus, Systemic, sponsored by Amgen.
NCT04925934 is a Phase 2 study of Lupus Erythematosus, Systemic that has completed, run by Amgen. The registered enrollment target is 214 participants, roughly in line with the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925934, a Phase 2 study of Lupus Erythematosus, Systemic, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG VIB7734
Study Locations (20)
Florida
- Clinical Research of West Florida Inc - Clearwater - Clearwater
- Millennium Research - Ormond Beach
- IRIS Research and Development LLC - Plantation
- Clinical Research of West Florida Inc - Tampa - Tampa
Texas
- Tekton Research Inc - Austin
- Precision Comprehensive Clinical Research Solutions - Colleyville
- Metroplex Clinical Research Center - Dallas
- Southwest Rheumatology Research, LLC - Mesquite
New York
- NYU Langone Ambulatory Care Brooklyn Heights - Brooklyn
- Feinstein Institute For Medical Research - Manhasset
- SUNY Upstate Medical Center - Syracuse
Buenos Aires
- Consultorios Médicos Dr. Doreski - Ciudad Autónoma de Buenos Aires
- Clínica Adventista Belgrano - Estomba
- Framingham Centro Médico - La Plata
California
- Inland Rheumatology Clinical Trials Incorporated - Upland
Georgia
- Emory University School of Medicine - Atlanta
Kentucky
- Bluegrass Community Research Inc - Lexington
North Carolina
- DJL Clinical Research - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2023-06-09 |
| Phase | Phase 2 |
What the finished NCT04925934 record still lists
NCT04925934 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target.
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04925934 names 20 study sites across 10 states, led by Florida, Texas, New York.
Frequently Asked Questions
What is clinical trial NCT04925934 about?
NCT04925934 is a clinical study titled "Study of VIB7734 for the Treatment of Moderate to Severely Active SLE". 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 pa...
What is the current status of trial NCT04925934?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2021-05-28. Estimated completion is 2023-06-09.
What conditions does trial NCT04925934 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT04925934?
The interventions under investigation include: Placebo (OTHER), VIB7734 (DRUG).
Who is sponsoring clinical trial NCT04925934?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04925934 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04925934's enrollment target sits among peer trials
214 11th of 29 higher than 19 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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