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NCT04058028 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
A Phase 2 study of Systemic Lupus Erythematosus (SLE), sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT04058028: Completed Phase 2 study of Systemic Lupus Erythematosus (SLE), sponsored by Amgen.
NCT04058028 is a Phase 2 study of Systemic Lupus Erythematosus (SLE) that has completed, run by Amgen. The registered enrollment target is 244 participants, below the 1,047-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04058028, a Phase 2 study of Systemic Lupus Erythematosus (SLE), has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
Primary Outcome
SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
Conditions Studied
Interventions
- DRUG Rozibafusp Alfa
- DRUG Placebo for Rozibafusp Alfa
Study Locations (20)
California
- Medvin Clinical Research - Covina
- Southern California Permanente Medical Group - Fontana
- University of California San Diego - La Jolla
- University of California Los Angeles - Los Angeles
- Stanford University Hospitals and Clinics - Palo Alto
- TriWest Research Associates - San Diego
Florida
- Centre for Rheumatology Immunology and Arthritis - Fort Lauderdale
- University of Florida - Gainesville
- Lakes Research LLC - Miami Lakes
- Heuer Medical Doctor Research LLC - Orlando
- Southwest Florida Clinical Research Center - Tampa
- AdventHealth Medical Group - Tampa
Georgia
- Piedmont Atlanta Hospital - Atlanta
- The Emory Clinic - Atlanta
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Imaging Endpoints - Scottsdale
Colorado
- University of Colorado Denver - Aurora
Connecticut
- Yale University - New Haven
Illinois
- Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc - Skokie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2023-07-25 |
| Phase | Phase 2 |
What the finished NCT04058028 record still lists
NCT04058028 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 1,047-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 2 interventions - of which Rozibafusp Alfa is the first listed.
NCT04058028 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04058028 about?
NCT04058028 is a clinical study titled "Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)". The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
What is the current status of trial NCT04058028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2020-02-19. Estimated completion is 2023-07-25.
What conditions does trial NCT04058028 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE).
What interventions are being tested in trial NCT04058028?
The interventions under investigation include: Rozibafusp Alfa (DRUG), Placebo for Rozibafusp Alfa (DRUG).
Who is sponsoring clinical trial NCT04058028?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04058028 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus (SLE)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04058028's enrollment target sits among peer trials
244 3rd of 14 higher than 11 of 14 other Systemic Lupus Erythematosus (SLE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus (SLE) 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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