Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: BT063; Placebo
Intervention description: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12); Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: SLE, Lupus; IL10, IL-10, BT063, BT-063

Summary:

      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.
    

Eligibility criteria:

        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