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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02711813
• Other study ID #: TAB08-SLE-01
• Status: Terminated
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Theramab LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• TAB08
biologic

Other:
• Placebo

Locations

Country	Name	City	State
Russian Federation	Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Theramab LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and proportion of treatment responders per SLE Responder Index (SRI)		24 weeks
Primary	Adverse Events		24 weeks
Secondary	Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)		24 weeks
Secondary	Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)		24 weeks