Phase 2
Completed N=36
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov NCT02554019 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Adverse Events — 5; 8; 8; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 8; 8; 1; 0; 0 | — |
| PRIMARY Number of Participants With Changes of Safety Parameters |
0; 0; 0 | — |
| SECONDARY Number of Participants With Improvements of Joints |
8; 5; 8; 7; 4; 7 | — |
| SECONDARY Number of Participants With Improvement of Skin |
6; 5; 3; 7; 4; 3 | — |
| SECONDARY Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000 |
-29.3; -18.0; -18.2; -28.9; -24.4; -13.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT02554019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.