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

NCT02804763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2021-06-30

Study results available
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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

  • Systemic Lupus Erythematosus (SLE)

Interventions

DRUG

Placebo

Solution for infusion, 0,9% saline

DRUG

Dapirolizumab pegol (DZP)

Solution for infusion

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-02
Primary Completion
2018-05-31
Completion
2018-11-19

Countries

  • United States
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Hungary
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804763 on ClinicalTrials.gov