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

NCT03522662 | Unknown Phase 2 DMC

• 1 other identifier: Behcet1070806
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet's Disease

Outcome Measures

Primary Outcomes (1)

• The occurrence of all moderate, severe and life threatening adverse events

  Events that that are possibly, probably or definitely attributable to a single IV dose of GSK1070806 (10mg/kg)

  24 weeks

Secondary Outcomes (3)

• All adverse events, including mild events

  24 weeks

• Measurement of disease activity

  24 weeks

• Measurement of the accumulation of damage

  24 weeks

Other Outcomes (2)

• Comparison of serum free IL-18 and total IL-18 levels

  6 weeks

• Comparison of downstream Th1 cytokines

  6 weeks

Interventions

GSK1070806 DRUG

Single 10mg/kg infusion on Day 0

Also known as: anti IL-18

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age under 18 years
• Allergies to humanized monoclonal antibodies
• Subjects who have received any of the following agents within 364 days of day 0:
• Alemtuzumab
• Rituximab or any other B cell depleting or modulating biological agent
• Subjects who have received any of the following agents within 180 days of day 0:
• Cyclophosphamide
• Anti-thymocyte globulin
• Subjects who have received any of the following agents within 90 days of Day 0:
• Intravenous immunoglobulin (IVIG)
• Plasmapheresis
• Subjects who have received any of the following agents within 30 days of Day 0:
• Anti-TNF (e.g. adalimumab, etanercept, infliximab)
• Anti-IL-6 therapy (e.g. tocilizumab)
• Interleukin-1 receptor antagonist (e.g. anakinra)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust

Cambridge, CB20QQ, United Kingdom

Location

MeSH Terms

Conditions

Behcet Syndrome

Interventions

GSK1070806

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Rona M Smith, MD MRCP

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rona M Smith, MD MRCP

CONTACT

00441223217259; rona.smith@addenbrookes.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Rona Smith

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 11, 2018
• Study Start: August 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)