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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Conc

Brief 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.

Detailed Summary:
Sponsor: Theramab LLC

Current Primary Outcome:

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


Original Primary Outcome:

  • SLE Responder Index (SRI) [ Time Frame: 24 weeks ]
  • Adverse Events [ Time Frame: 24 weeks ]


Current Secondary Outcome:

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


Original Secondary Outcome:

  • SF-36 [ Time Frame: 24 weeks ]
  • CLASI [ Time Frame: 24 weeks ]


Information By: Theramab LLC

Dates:
Date Received: March 14, 2016
Date Started: March 2016
Date Completion: June 2017
Last Updated: December 5, 2016
Last Verified: December 2016