Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)

Phase 1

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 19.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-005526-35-PL
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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 × 109/L
- Leucocytes < 2.0 × 109/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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified