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NCT02804763 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
A Phase 2 study of Systemic Lupus Erythematosus (SLE), sponsored by UCB Biopharma S.P.R.L..
- Completed
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT02804763: Completed Phase 2 study of Systemic Lupus Erythematosus (SLE), sponsored by UCB Biopharma S.P.R.L..
NCT02804763 is a Phase 2 study of Systemic Lupus Erythematosus (SLE) that has completed, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 182 participants, below the 1,052-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02804763, a Phase 2 study of Systemic Lupus Erythematosus (SLE), has completed, sponsored by UCB Biopharma S.P.R.L..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
Primary Outcome
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: A scores at Baseline improved to B,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dapirolizumab pegol (DZP)
Study Locations (20)
California
- Sl0023 307 - El Cajon
- Sl0023 309 - El Cajon
- Sl0023 323 - Huntington Beach
- Sl0023 311 - Los Angeles
- Sl0023 314 - Thousand Oaks
- Sl0023 302 - Upland
Florida
- Sl0023 304 - Clearwater
- Sl0023 322 - DeBary
- Sl0023 321 - Miami
- Sl0023 301 - Miami Lakes
- Sl0023 319 - Palm Harbor
- Sl0023 310 - Tampa
Georgia
- Sl0023 324 - Atlanta
- Sl0023 327 - Stockbridge
Alabama
- Sl0023 312 - Birmingham
Connecticut
- Sl0023 326 - New Haven
Idaho
- Sl0023 320 - Idaho Falls
New Mexico
- Sl0023 306 - Albuquerque
New York
- Sl0023 313 - Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2016-06-02 |
| Est. Completion | 2018-11-19 |
| Phase | Phase 2 |
What the finished NCT02804763 record still lists
NCT02804763 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,052-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02804763 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02804763 about?
NCT02804763 is a clinical study titled "A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus". The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
What is the current status of trial NCT02804763?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2016-06-02. Estimated completion is 2018-11-19.
What conditions does trial NCT02804763 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE).
What interventions are being tested in trial NCT02804763?
The interventions under investigation include: Placebo (DRUG), Dapirolizumab pegol (DZP) (DRUG).
Who is sponsoring clinical trial NCT02804763?
This trial is sponsored by UCB Biopharma S.P.R.L., which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02804763 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. 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 NCT02804763's enrollment target sits among peer trials
182 6th of 14 higher than 9 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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