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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02554019
• Date of registration: 16/09/2015
• Prospective Registration: Yes
• Primary sponsor: Biotest
• Public title: Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus BT063 in SLE
• Scientific title: A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: September 28, 2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02554019
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belarus, Georgia, Poland, Serbia

Contacts

• Name: Nemanja Damjanov, Professor
• Affiliation: Institute of Rheumatology, University of Belgrade School of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: BT063

Biological: Placebo

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Baseline through End of Trial Visit (Week 14)]

Number of Participants With Changes of Safety Parameters [Time Frame: Baseline through End of Trial Visit (Week 14)]

Secondary Outcome(s)

Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000 [Time Frame: Baseline to week 14 and at week 28]

Number of Participants With Improvement of Skin [Time Frame: At week14 and week 28]

Number of Participants With Improvements of Joints [Time Frame: At week14 and week 28]

Secondary ID(s)

990

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02554019