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

May 21, 2018 updated by: Theramab LLC

Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
  • Active SLE (SLE Disease Activity Index ≥ 6)
  • Skin or joint SLE manifestations

Exclusion Criteria:

  • Lupus-nephritis and/or central nervous system affection (neuro-lupus)
  • Prohibited treatment
  • Pregnant or nursing women
  • Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo to TAB08
Other: Placebo
Experimental: TAB08 Dose 1
Drug: TAB08
biologic
Experimental: TAB08 Dose 2
Drug: TAB08
biologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of treatment responders per SLE Responder Index (SRI)
Time Frame: 24 weeks
24 weeks
Adverse Events
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
Time Frame: 24 weeks
24 weeks
Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theramab LLC

Investigators

  • Study Director: Daniil Nemenov, M.D., Theramab LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAB08-SLE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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