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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02711813

Enrollment

Registered

2016-03-17

Start date

2016-03-31

Completion date

2018-05-31

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Systemic

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.

Interventions

DRUGTAB08

biologic

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026