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TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

NCT02711813 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-05-23

No results posted yet for this study

Summary

The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

TAB08

biologic

OTHER

Placebo

Sponsors & Collaborators

  • Theramab LLC

    lead INDUSTRY

Principal Investigators

  • Daniil Nemenov, M.D. · Theramab LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Russia

Study Locations

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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 NCT02711813 on ClinicalTrials.gov