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Behcet's DiseasePhase 2NCT03522662

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

A Phase 2 study testing GSK1070806 in people with Behcet's Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Behcet's Disease
What is being tested?
GSK1070806
Type of treatment
Injection or infusion
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2018to 1 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 31Show fewer
  • 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)
  • Alpha interferon
  • Any live vaccine
  • 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.
  • Subjects required more than 15mg prednisolone daily in the 4 week run in phase.
  • Positive human immunodeficiency virus (HIV) antibody test
  • Positive serology for Hepatitis B (HB), defined as: (i) HB surface antigen positive (HBsAg+) OR (ii) HB core antibody positive (HBcAb+)
  • Positive Hepatitis C (HCV) antibody test
  • 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.
  • Evidence of chronic infection requiring long term antimicrobial therapy
  • Serum IgG level < 3g/l
  • 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.
  • 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).
  • Liver function: ALT > 2xULN and bilirubin > 1.5 ULN (isolated bilirubin > 1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
  • 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
  • Women who are pregnant or breast feeding
  • 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

Trial locations and contacts

1 site in 1 country.

Rona M Smith, MD MRCP contact

00441223217259

rona.smith@addenbrookes.nhs.uk

United Kingdom1 site

  • Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust

    Cambridge, CB20QQ

Other trials in United Kingdom

About this study

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

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.

Being tested
GSK1070806
Medical subject headings
Behcet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1070806Drug

    Also called anti IL-18

    Single 10mg/kg infusion on Day 0

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 weeks

Secondary outcomes (3)

  1. All adverse events, including mild events

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

    Measured: 24 weeks

  2. Measurement of disease activity

    Using a clinical scoring tool, the Behcet's disease current activity form (BDCAF)

    Measured: 24 weeks

  3. Measurement of the accumulation of damage

    Using a clinical scoring tool, the Vasculitis Damage Index (VDI)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start1 Aug 2018 (estimated)
  3. Primary completion1 Apr 2020 (estimated)
  4. Study completion1 Apr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522662
Sponsor's protocol ID
Behcet1070806
Status last verified
May 2018
First submitted
1 May 2018
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1070806 in people with Behcet's Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rona M Smith, MD MRCP (00441223217259, rona.smith@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of all moderate, severe and life threatening adverse events (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03522662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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