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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02554019
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Biotest

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: BT063 Biological: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2015
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: BT063
50 mg BT063 administered by intravenous (IV) infusion 8 times
Biological: BT063
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Placebo Comparator: Placebo
Placebo administered by IV infusion 8 times
Biological: Placebo
Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Baseline through End of Trial Visit (Week 14) ]
    Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14)

  2. Number of Participants With Changes of Safety Parameters [ Time Frame: Baseline through End of Trial Visit (Week 14) ]
    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 :
  1. Number of Participants With Improvements of Joints [ Time Frame: At week14 and week 28 ]
    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.

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

    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.


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

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554019


Locations
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Belarus
Study Site 37505
Gomel, Belarus
Study Site 37503
Minsk District, Belarus
Study Site 37501
Minsk, Belarus
Study Site 37502
Minsk, Belarus
Study Site 37504
Vitebsk, Belarus
Georgia
Study Site 99501
Tbilisi, Georgia
Study Site 99502
Tbilisi, Georgia
Poland
Study Site 48003
Bialystok, Poland
Study Site 48004
Krakow, Poland
Study Site 48002
Poznan, Poland
Study Site 48001
Warsaw, Poland
Serbia
Study Site 38101
Belgrade, Serbia
Study Site 38103
Belgrade, Serbia
Study Site 38102
Niska Banja, Serbia
Sponsors and Collaborators
Biotest
Investigators
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Principal Investigator: Nemanja Damjanov, Professor Institute of Rheumatology, University of Belgrade School of Medicine
  Study Documents (Full-Text)

Documents provided by Biotest:
Study Protocol  [PDF] March 19, 2015
Statistical Analysis Plan  [PDF] January 23, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT02554019    
Other Study ID Numbers: 990
First Posted: September 18, 2015    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Biotest:
SLE, Lupus
IL10, IL-10, BT063, BT-063
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases