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

NCT ID: NCT02554019

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-28
• Study Completion Date: 2017-10-25

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BT063

50 mg BT063 administered by intravenous (IV) infusion 8 times

Group Type: EXPERIMENTAL

BT063

Intervention Type: BIOLOGICAL

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Placebo

Placebo administered by IV infusion 8 times

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Interventions

BT063

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Intervention Type: BIOLOGICAL

Placebo

Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotest

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nemanja Damjanov, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Rheumatology, University of Belgrade School of Medicine

Locations

Study Site 37505

Homyel, , Belarus

Study Site 37501

Minsk, , Belarus

Study Site 37502

Minsk, , Belarus

Study Site 37503

Minsk District, , Belarus

Study Site 37504

Vitebsk, , Belarus

Study Site 99501

Tbilisi, , Georgia

Study Site 99502

Tbilisi, , Georgia

Study Site 48003

Bialystok, , Poland

Study Site 48004

Krakow, , Poland

Study Site 48002

Poznan, , Poland

Study Site 48001

Warsaw, , Poland

Study Site 38101

Belgrade, , Serbia

Study Site 38103

Belgrade, , Serbia

Study Site 38102

Niška Banja, , Serbia

Countries

Belarus; Georgia; Poland; Serbia

References

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.

Reference Type: DERIVED

PMID: 33687069 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

990

Identifier Type: -

Identifier Source: org_study_id