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Anti IL-18 (GSK1070806) in Behcet's Disease

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ClinicalTrials.gov Identifier: NCT03522662
Recruitment Status : Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Rona Smith, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
The primary outcome measure of the study is to demonstrate the safety and tolerability of GSK1070806 in the Behcet's disease population at 24 weeks, with biochemical and clinical efficacy and mechanistic studies to further explore the pathogenesis of Behcet's disease important secondary and exploratory outcomes.

Condition or disease Intervention/treatment Phase
Behcet's Disease Drug: GSK1070806 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Experimental Medicine Study to Characterise the Importance of IL-18 Production and to Evaluate the Therapeutic Potential of IL-18 Blockade With GSK1070806 in Subjects With Behcet's Disease
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020



Intervention Details:
  • Drug: GSK1070806
    Single 10mg/kg infusion on Day 0
    Other Name: anti IL-18


Primary Outcome Measures :
  1. The occurrence of all moderate, severe and life threatening adverse events [ Time Frame: 24 weeks ]
    Events that that are possibly, probably or definitely attributable to a single IV dose of GSK1070806 (10mg/kg)


Secondary Outcome Measures :
  1. All adverse events, including mild events [ Time Frame: 24 weeks ]
    Events that that are possibly, probably or definitely attributable to a single IV dose of GSK1070806 (10mg/kg)

  2. Measurement of disease activity [ Time Frame: 24 weeks ]
    Using a clinical scoring tool, the Behcet's disease current activity form (BDCAF)

  3. Measurement of the accumulation of damage [ Time Frame: 24 weeks ]
    Using a clinical scoring tool, the Vasculitis Damage Index (VDI)


Other Outcome Measures:
  1. Comparison of serum free IL-18 and total IL-18 levels [ Time Frame: 6 weeks ]
    Pre and post GSK1070806

  2. Comparison of downstream Th1 cytokines [ Time Frame: 6 weeks ]
    Including interferon gamma, IP-10, IL-10, IL-2, IL-1β and TNF. Pre and post GSK1070806.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have given written informed consent to participate
  • Be aged 18 years and over
  • Have a diagnosis of Behcet's disease (according to the International Study Group (ISG) diagnostic guidelines or International Criteria for BD (ICBD)).
  • Have active disease, severe enough to necessitate the use of biological therapy at the time of enrolment (i.e. Subjects have refractory disease as defined by the UK Centres of Excellence criteria as failure to respond to steroid and/or immunosuppressive therapy with significant or major organ-threatening disease.

Exclusion Criteria:

  1. Age under 18 years
  2. Allergies to humanized monoclonal antibodies
  3. Subjects who have received any of the following agents within 364 days of day 0:

    1. Alemtuzumab
    2. Rituximab or any other B cell depleting or modulating biological agent
  4. Subjects who have received any of the following agents within 180 days of day 0:

    1. Cyclophosphamide
    2. Anti-thymocyte globulin
  5. Subjects who have received any of the following agents within 90 days of Day 0:

    1. Intravenous immunoglobulin (IVIG)
    2. Plasmapheresis
  6. Subjects who have received any of the following agents within 30 days of Day 0:

    1. Anti-TNF (e.g. adalimumab, etanercept, infliximab)
    2. Anti-IL-6 therapy (e.g. tocilizumab)
    3. Interleukin-1 receptor antagonist (e.g. anakinra)
    4. Alpha interferon
    5. Any live vaccine
  7. Subjects who have received any other investigational product within 30 days, 5 half lives or twice the duration of the biological effect, whichever is longer.
  8. Subjects required more than 15mg prednisolone daily in the 4 week run in phase.
  9. Positive human immunodeficiency virus (HIV) antibody test
  10. Positive serology for Hepatitis B (HB), defined as: (i) HB surface antigen positive (HBsAg+) OR (ii) HB core antibody positive (HBcAb+)
  11. Positive Hepatitis C (HCV) antibody test
  12. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and a positive (not indeterminate) QuantiFERON®-TB Gold test.
  13. Evidence of chronic infection requiring long term antimicrobial therapy
  14. Serum IgG level < 3g/l
  15. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and carcinoma in situ of the uterine cervix.
  16. QTc interval (single or average) > 480msec or in subjects with bundle branch block QTc > 500msec (these criteria do not apply to subjects with predominantly paced rhythm).
  17. Liver function: ALT > 2xULN and bilirubin > 1.5 ULN (isolated bilirubin > 1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
  18. Compliance: is unlikely to comply with scheduled study visits based on investigator judgment or has a history of substance abuse, psychiatric disorder or condition that may compromise communication with the investigator
  19. Women who are pregnant or breast feeding
  20. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for one month before and 12 months after administration of GSK1070806

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): NCT03522662


Contacts
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Contact: Rona M Smith, MD MRCP 00441223217259 rona.smith@addenbrookes.nhs.uk

Locations
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United Kingdom
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom, CB20QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Rona M Smith, MD MRCP Cambridge University Hospitals NHS Foundation Trust

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Responsible Party: Dr. Rona Smith, Dr Rona Smith, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03522662     History of Changes
Other Study ID Numbers: Behcet1070806
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vasculitis
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular