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NCT06617325 · 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.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06617325: Recruiting Phase 3 study of Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL.
NCT06617325 is a Phase 3 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by UCB Biopharma SRL. The registered enrollment target is 450 participants, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06617325, a Phase 3 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by UCB Biopharma SRL.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 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
A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease
Conditions Studied
Interventions
- OTHER Placebo
- DRUG DZP
Study Locations (20)
California
- Sl0044 50737 - Beverly Hills
- Sl0044 50257 - La Jolla
- Sl0044 50275 - La Palma
- Sl0044 50755 - Los Alamitos
- Sl0044 50258 - Los Angeles
- Sl0044 50725 - Menifee
- Sl0044 50340 - Orange
- Sl0044 50316 - San Leandro
Arizona
- Sl0044 50058 - Avondale
- Sl0044 50550 - Chandler
- Sl0044 50713 - Gilbert
- Sl0044 50662 - Glendale
- Sl0044 50052 - Phoenix
Florida
- Sl0044 50239 - Brandon
- Sl0044 50630 - Clearwater
- Sl0044 50747 - Coral Gables
- Sl0044 50751 - Coral Gables
- Sl0044 50362 - Gainesville
Arkansas
- Sl0044 50670 - Searcy
Colorado
- Sl0044 50719 - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 3 |
What NCT06617325 shows while recruiting
NCT06617325 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (20% higher).
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.
NCT06617325 names 20 study sites across 5 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06617325 about?
NCT06617325 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 NCT06617325?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-11-21. Estimated completion is 2028-05-31.
What conditions does trial NCT06617325 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06617325?
The interventions under investigation include: Placebo (OTHER), DZP (DRUG).
Who is sponsoring clinical trial NCT06617325?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06617325 being conducted?
This trial has 20 study locations across Arizona, Arkansas, 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 NCT06617325's enrollment target sits among peer trials
450 18th of 99 higher than 82 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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