Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus (BT063 in SLE)

Biotest

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: BT063; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554019

990

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.

Full description

Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is divided into 2 parts. After Part I an interim analysis will be performed. Each Part will enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times over 12 weeks and will be followed for 4 months after their last dose.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible male and female subjects, Age ≥ 18 and ≤ 75 years with Body mass index ≥ 18 and ≤ 35 kg/m2 at screening visit
• Diagnosed SLE (defined by ≥ 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE) for at least 3 months before screening
• Moderate to severe SLE disease activity demonstrated by SLEDAI-2K total score ≥ 6, including skin and joint involvement
• CLASI Activity score ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation
• Positive anti-nuclear antibodies (ANA) test at screening
• No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks)
• Normal electrocardiogram (ECG)

Exclusion criteria

• Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis
• Diagnosed psoriasis
• Presence or history of malignancy within the previous 5 years
• Systemic antibiotic treatment within 2 weeks before baseline visit
• A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening
• Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin < 8 g/dL; Platelets < 50 E9/L; Leucocytes < 2.0 E9/L
• Active or history of inflammatory bowel disease (including active or history of colitis)
• Received the following medications: - Rituximab within the last 48 weeks before screening - Belimumab within the last 12 weeks before screening - IV immunoglobulin (Ig) within the last 12 weeks before screening - Intramuscular (IM) or intra-articular glucocorticosteroids within the last 4 weeks before screening - IV cyclophosphamide within the last 6 months before screening - IV glucocorticosteroids (pulse therapy) within the last 6 months before screening
• Pregnant or nursing women or women who intend to become pregnant
• Known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction)
• Known intolerance to proteins of human origin
• History of clinically significant drug or alcohol abuse within the last 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

BT063

Experimental group

Description:

50 mg BT063 administered by intravenous (IV) infusion 8 times

Treatment:

Biological: BT063

Placebo

Placebo Comparator group

Description:

Placebo administered by IV infusion 8 times

Treatment:

Biological: Placebo