Clinical Trials Directory

Trials / Completed

CompletedNCT02804763

A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
182 (actual)
Sponsor
UCB Biopharma S.P.R.L. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPlaceboSolution for infusion, 0,9% saline
DRUGDapirolizumab pegol (DZP)Solution for infusion

Timeline

Start date
2016-06-02
Primary completion
2018-05-31
Completion
2018-11-19
First posted
2016-06-17
Last updated
2021-06-30
Results posted
2021-06-30

Locations

71 sites across 13 countries: United States, Bulgaria, Chile, Colombia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russia, Spain, Ukraine

Source: ClinicalTrials.gov record NCT02804763. Inclusion in this directory is not an endorsement.