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NCT04294667 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
A Phase 3 study of Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
- 20
- Study locations
NCT04294667: Completed Phase 3 study of Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL.
NCT04294667 is a Phase 3 study of Systemic Lupus Erythematosus that has completed, run by UCB Biopharma SRL. The registered enrollment target is 321 participants, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294667, a Phase 3 study of Systemic Lupus Erythematosus, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Primary Outcome
Study participants were considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following were fulfilled: * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[≤\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Con
Conditions Studied
Interventions
- OTHER Placebo
- DRUG DZP
Study Locations (20)
California
- Sl0043 50383 - Beverly Hills
- Sl0043 50257 - La Jolla
- Sl0043 50275 - La Palma
- Sl0043 50378 - Loma Linda
- Sl0043 50258 - Los Angeles
- Sl0043 50340 - Orange
- Sl0043 50331 - Poway
- Sl0043 50377 - San Diego
- Sl0043 50316 - San Leandro
Florida
- Sl0043 50239 - Brandon
- Sl0043 50362 - Gainesville
- Sl0043 50122 - Miami
- Sl0043 50059 - Ormond Beach
- Sl0043 50324 - Plantation
Arizona
- Sl0043 50052 - Phoenix
- Sl0043 50328 - Tucson
Alabama
- Sl0043 50140 - Birmingham
Colorado
- Sl0043 50339 - Denver
Connecticut
- Sl0043 50367 - New Haven
District of Columbia
- Sl0043 50341 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 3 |
What the finished NCT04294667 record still lists
NCT04294667 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (15% lower).
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.
NCT04294667 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04294667 about?
NCT04294667 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus". The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
What is the current status of trial NCT04294667?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2020-08-12. Estimated completion is 2024-06-04.
What conditions does trial NCT04294667 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT04294667?
The interventions under investigation include: Placebo (OTHER), DZP (DRUG).
Who is sponsoring clinical trial NCT04294667?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04294667 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
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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 NCT04294667's enrollment target sits among peer trials
321 26th of 99 higher than 74 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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