NCT02554019

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

September 28, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

September 16, 2015

Results QC Date

September 24, 2019

Last Update Submit

January 15, 2020

Conditions

Systemic Lupus Erythematosus

Keywords

SLE, LupusIL10, IL-10, BT063, BT-063

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    Baseline through End of Trial Visit (Week 14)

Secondary Outcomes (3)

  • Number of Participants With Improvements of Joints

    At week14 and week 28

  • Number of Participants With Improvement of Skin

    At week14 and week 28

  • Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000

    Baseline to week 14 and at week 28

Study Arms (2)

BT063

EXPERIMENTAL

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

Biological: BT063

Placebo

PLACEBO COMPARATOR

Placebo administered by IV infusion 8 times

Biological: Placebo

Interventions

BT063BIOLOGICAL

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

BT063
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Study Site 37505

Homyel, Belarus

Location

Study Site 37501

Minsk, Belarus

Location

Study Site 37502

Minsk, Belarus

Location

Study Site 37503

Minsk District, Belarus

Location

Study Site 37504

Vitebsk, Belarus

Location

Study Site 99501

Tbilisi, Georgia

Location

Study Site 99502

Tbilisi, Georgia

Location

Study Site 48003

Bialystok, Poland

Location

Study Site 48004

Krakow, Poland

Location

Study Site 48002

Poznan, Poland

Location

Study Site 48001

Warsaw, Poland

Location

Study Site 38101

Belgrade, Serbia

Location

Study Site 38103

Belgrade, Serbia

Location

Study Site 38102

Niška Banja, Serbia

Location

Related Publications (1)

  • 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.

    PMID: 33687069DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr. Peter Röttgen
Organization
Biotest AG
peter.roettgen@biotest.com
+496103801

Study Officials

  • Nemanja Damjanov, Professor

    Institute of Rheumatology, University of Belgrade School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 18, 2015

Study Start

September 28, 2015

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

January 27, 2020

Results First Posted

January 27, 2020

Record last verified: 2020-01

Locations

GE(2)BE(5)PL(4)SE(3)