Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Public ClinicalTrials.gov record NCT04058028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04058028
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 244 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 18, 2020
- Primary completion
- Jul 24, 2023
- Completion
- Jul 24, 2023
- Last update posted
- Sep 23, 2024
2020 – 2023
United States locations
- U.S. sites
- 39
- U.S. states
- 17
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Imaging Endpoints | Scottsdale | Arizona | 85258 | — |
| Medvin Clinical Research | Covina | California | 91723 | — |
| Southern California Permanente Medical Group | Fontana | California | 92335 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Stanford University Hospitals and Clinics | Palo Alto | California | 94304 | — |
| TriWest Research Associates | San Diego | California | 92108 | — |
| University of Colorado Denver | Aurora | Colorado | 80010 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Centre for Rheumatology Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Lakes Research LLC | Miami Lakes | Florida | 33014 | — |
| Heuer Medical Doctor Research LLC | Orlando | Florida | 32819 | — |
| Southwest Florida Clinical Research Center | Tampa | Florida | 33609 | — |
| AdventHealth Medical Group | Tampa | Florida | 33613 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30318 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc | Skokie | Illinois | 60076 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| University of Maryland School of Medicine Division of Rheumatology | Baltimore | Maryland | 21201 | — |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | — |
| New York University Langone Orthopedic Center | New York | New York | 10016 | — |
| Hospital For Special Surgery | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | — |
| DJL Clinical Research PLLC | Charlotte | North Carolina | 28210 | — |
| Arthritis and Rheumatology Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73102 | — |
| The Oklahoma Center for Arthritis Therapy and Research Inc | Tulsa | Oklahoma | 74104 | — |
| Penn State Milton South Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Articularis Healthcare Group Inc dba Low Country Rheumatology | Summerville | South Carolina | 29486 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Austin Regional Clinic Specialty Research | Austin | Texas | 78731 | — |
| Trinity Universal Research Associates, Inc | Carrollton | Texas | 75007 | — |
| Rheumatic Disease Clinical Research Center LLC | Houston | Texas | 77004 | — |
| Southwest Rheumatology | Mesquite | Texas | 75150 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04058028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04058028 live on ClinicalTrials.gov.