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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BT063
Placebo
Sponsored by
Biotest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, IL10, IL-10, BT063, BT-063

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Study Site 37505
  • Study Site 37503
  • Study Site 37501
  • Study Site 37502
  • Study Site 37504
  • Study Site 99501
  • Study Site 99502
  • Study Site 48003
  • Study Site 48004
  • Study Site 48002
  • Study Site 48001
  • Study Site 38101
  • Study Site 38103
  • Study Site 38102

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BT063

Placebo

Arm Description

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

Placebo administered by IV infusion 8 times

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14)
Number of Participants With Changes of Safety Parameters
Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals.

Secondary Outcome Measures

Number of Participants With Improvements of Joints
Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity.
Number of Participants With Improvement of Skin
Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study. The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome.
Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000
Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score. The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity.

Full Information

First Posted
September 16, 2015
Last Updated
January 15, 2020
Sponsor
Biotest
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1. Study Identification

Unique Protocol Identification Number
NCT02554019
Brief Title
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Acronym
BT063 in SLE
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2015 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE, Lupus, IL10, IL-10, BT063, BT-063

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BT063
Arm Type
Experimental
Arm Description
50 mg BT063 administered by intravenous (IV) infusion 8 times
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered by IV infusion 8 times
Intervention Type
Biological
Intervention Name(s)
BT063
Intervention Description
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14)
Time Frame
Baseline through End of Trial Visit (Week 14)
Title
Number of Participants With Changes of Safety Parameters
Description
Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals.
Time Frame
Baseline through End of Trial Visit (Week 14)
Secondary Outcome Measure Information:
Title
Number of Participants With Improvements of Joints
Description
Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity.
Time Frame
At week14 and week 28
Title
Number of Participants With Improvement of Skin
Description
Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study. The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome.
Time Frame
At week14 and week 28
Title
Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000
Description
Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score. The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity.
Time Frame
Baseline to week 14 and at week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nemanja Damjanov, Professor
Organizational Affiliation
Institute of Rheumatology, University of Belgrade School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study Site 37505
City
Gomel
Country
Belarus
Facility Name
Study Site 37503
City
Minsk District
Country
Belarus
Facility Name
Study Site 37501
City
Minsk
Country
Belarus
Facility Name
Study Site 37502
City
Minsk
Country
Belarus
Facility Name
Study Site 37504
City
Vitebsk
Country
Belarus
Facility Name
Study Site 99501
City
Tbilisi
Country
Georgia
Facility Name
Study Site 99502
City
Tbilisi
Country
Georgia
Facility Name
Study Site 48003
City
Bialystok
Country
Poland
Facility Name
Study Site 48004
City
Krakow
Country
Poland
Facility Name
Study Site 48002
City
Poznan
Country
Poland
Facility Name
Study Site 48001
City
Warsaw
Country
Poland
Facility Name
Study Site 38101
City
Belgrade
Country
Serbia
Facility Name
Study Site 38103
City
Belgrade
Country
Serbia
Facility Name
Study Site 38102
City
Niska Banja
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
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.
Results Reference
derived

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

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