Clinical trial NCT02554019: Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE, Lupus
IL10, IL-10, BT063, BT-063
Lead sponsor: Biotest
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline through End of Trial Visit (Week 14)
measure: Number of Participants With Changes of Safety Parameters
timeFrame: Baseline through End of Trial Visit (Week 14)
Secondary outcomes:
measure: Number of Participants With Improvements of Joints
timeFrame: At week14 and week 28
measure: Number of Participants With Improvement of Skin
timeFrame: At week14 and week 28
measure: Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000
timeFrame: Baseline to week 14 and at week 28
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Study Site 37505
city: Minsk District
country: Belarus
facility: Study Site 37503
city: Minsk
country: Belarus
facility: Study Site 37501
city: Minsk
country: Belarus
facility: Study Site 37502
city: Vitebsk
country: Belarus
facility: Study Site 37504
city: Tbilisi
country: Georgia
facility: Study Site 99501
city: Tbilisi
country: Georgia
facility: Study Site 99502
city: Bialystok
country: Poland
facility: Study Site 48003
city: Krakow
country: Poland
facility: Study Site 48004
city: Poznan
country: Poland
facility: Study Site 48002
city: Warsaw
country: Poland
facility: Study Site 48001
city: Belgrade
country: Serbia
facility: Study Site 38101
city: Belgrade
country: Serbia
facility: Study Site 38103
city: Niska Banja
country: Serbia
facility: Study Site 38102
Study officials:
affiliation: Institute of Rheumatology, University of Belgrade School of Medicine
name: Nemanja Damjanov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.