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

Theramab

Status and phase: Terminated; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Other: Placebo; Drug: TAB08

Study type: Interventional

Funder types: Industry

Identifiers

NCT02711813

TAB08-SLE-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to TAB08

Treatment:

Other: Placebo

TAB08 Dose 1

Experimental group

Treatment:

Drug: TAB08

TAB08 Dose 2

Experimental group

Treatment:

Drug: TAB08