CDAID GSK1070806
Research type
Research Study
Full title
A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease
IRAS ID
251945
Contact name
Marietta Iacucci
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2018-002001-65
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
In this trial we will be using a treatment called GSK1070806 to assess whether it can be delivered safely via intravenous infusion (IV) in patients with moderate to severe Crohn’s disease. Patients who consent to take part in the trial will be allocated a place in the trial and will receive one dose of the active GSK1070806 drug or a placebo drug.
Crohn’s disease is a disorder that causes inflammation of the gastrointestinal tract from mouth to anus. Crohn’s disease is a type of inflammatory bowel disease and can present with a range of symptoms including diarrhoea, abdominal pain, tiredness and fatigue. The treatment of inflammatory bowel disease, both ulcerative colitis and Crohn’s disease is rapidly changing. Current therapies aim to control inflammation in the gut rather than simply control symptoms. Therefore, accurate assessment of the presence or absence of inflammation of the lining of the gut and healing of ulcers in ulcerative colitis and Crohn’s disease is important. Currently the treatment for Crohn’s disease can be medicinal, surgical or a combination of both.
In this trial we aim to assess the safety and tolerability of an antibody treatment GSK1070806 in patients with moderate to severe Crohn’s disease. IL-18 is a key cytokine involved in inflammation resulting in Crohn’s disease. We are testing an antibody to this key cytokine in moderate to severe Crohn’s disease where there is a large unmet need. The drug will be delivered via IV over approximately 1 hour. We will also be looking at the change in CDAI score over the course of the trial (24 weeks). Patients will be treated in the Wellcome Clinical Research Facility at University Hospitals Birmingham NHS Foundation Trust.
|Summary of Results
Abstract Crohn’s disease (CD) is a type of debilitating inflammatory bowel disease that causes inflammation of the gastrointestinal tract. Symptoms include diarrhoea, abdominal pain, tiredness and fatigue. Current therapies aim to control inflammation in the gut rather than symptoms. Therefore, accurate assessment of the presence or absence of inflammation of the lining of the gut in CD is important. IL-18 is a key cytokine involved in the inflammatory process in CD. This placebo-controlled trial aimed to assess the safety and tolerability of an antibody treatment called GSK1070806 to the IL-18 cytokine in 36 patients with moderate to severe CD. However, due to expiring drug product and slow recruitment, an amendment to reduce the recruitment target and remove the Crohn’s Disease Activity Index (CDAI) score from the eligibility criteria, meant that fewer patients with milder disease were recruited.
Five patients were recruited to the trial and followed up. The average age at trial entry was 39.4 years (range 21 to 47 years) with the majority being female (4 out of 5). All five patients had mildly active disease at screening with a mean (SD) CDAI score of 136.4 (39.12), range 102 – 200. Four patients received GSK1070806, and one patient received the placebo control. Of the 119 Adverse Events reported, all were unrelated or unlikely to be related to treatment. There were no deaths or drug induced liver injuries. The two Serious Adverse Events (SAEs) reported were not related to treatment.
The trial had several limitations, notably the change in patient population studied (mild disease vs moderate/severe disease planned) and poor recruitment rate (5 participants vs 36 planned). Nonetheless, single dose intravenous administrations of humanised antibody GSK1070806 caused no related SAEs and no drug related toxicities in treated patients with CD.REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0320
Date of REC Opinion
12 Dec 2018
REC opinion
Further Information Favourable Opinion