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NCT04877691 · ClinicalTrials.gov registry record · Phase 3
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 367
- Enrollment target
- 20
- Study locations
NCT04877691: Active Phase 3 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
NCT04877691 is a Phase 3 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 367 participants, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04877691, a Phase 3 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 367 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Primary Outcome
BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria: * Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG 2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is define
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Medi-546
Study Locations (20)
California
- Research Site - El Cajon
- Research Site - Fullerton
- Research Site - Hemet
- Research Site - La Mesa
- Research Site - Los Angeles
- Research Site - Menifee
- Research Site - Upland
Florida
- Research Site - Brandon
- Research Site - Clearwater
- Research Site - Clearwater
- Research Site - Miami
- Research Site - Tampa
- Research Site - Tampa
Arizona
- Research Site - Paradise Valley
- Research Site - Phoenix
Michigan
- Research Site - Flint
- Research Site - Lansing
Alabama
- Research Site - Birmingham
Colorado
- Research Site - Aurora
Idaho
- Research Site - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2026-11-06 |
| Phase | Phase 3 |
What the registry record for NCT04877691 still lists
NCT04877691 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04877691 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04877691 about?
NCT04877691 is a clinical study titled "Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus". The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
What is the current status of trial NCT04877691?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2021-06-08. Estimated completion is 2026-11-06.
What conditions does trial NCT04877691 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT04877691?
The interventions under investigation include: Placebo (DRUG), Medi-546 (DRUG).
Who is sponsoring clinical trial NCT04877691?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04877691 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
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 NCT04877691's enrollment target sits among peer trials
367 23rd of 99 higher than 77 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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