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Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

NCT02554019 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-27

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.

Conditions

Interventions

BIOLOGICAL

BT063

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

BIOLOGICAL

Placebo

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Nemanja Damjanov, Professor · Institute of Rheumatology, University of Belgrade School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-28
Primary Completion
2017-10-25
Completion
2017-10-25

Countries

  • Belarus
  • Georgia
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02554019 on ClinicalTrials.gov