ANB020-004 Placebo controlled study in Adults with Eosinophilic Asthma
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients with Severe Eosinophilic Asthma
126765, IND No.
Duration of Study in the UK
0 years, 10 months, 30 days
This is a phase IIa proof of concept study, investigating the safety, tolerability and activity of a single 300mg/100ml intravenous (IV) infusion dose of ANB020 compared to placebo in patients with severe eosinophilic asthma.\nApproximately 24 patients age between 18 and 65 years old with severe eosinophilic asthma will be recruited to take part in the study. The study will be conducted at 3 centres in UK.\nThe study consists of 3 periods:\no\tScreening Period (7 to 14 days prior to Day 1)\no\tTreatment Day (Day 1)\no\tFollow-up Period (Day 2 to Day 127, including telephone interviews and study centre visits).\nPatients who meet inclusion and exclusion criteria and have signed an informed consent form will be randomly assigned in ratio 1:1 to either single dose of ANB020 or placebo treatment arm. The process is called randomisation and means that the treatment choice will be decided by chance, like a toss of a coin. Both placebo and study drug will be administered by intravenous (into a vein) infusions. Neither patients nor the study doctor will know if patients are receiving study drug or placebo. \nDuring the study all patients will undergo study specific assessments and safety laboratory tests. Blood and urine samples will be collected for routine health and safety testing. Blood samples will also be taken for pharmacokinetic (PK - measures how the body processes the drug) and pharmacodynamics (PD - measures how the drug affects the body) assessments of the study drug and immunity testing. In addition tests to check lungs function and identify airway inflammation will be performed and patients will be required to complete several health questionnaires and patient diary. \nAll patients will be followed for 18 weeks after receiving dose of ANB020 or placebo. During the follow-up period, patients will be required to attend visits at the study centre and will be contacted via telephone by study staff.
London - Hampstead Research Ethics Committee
Date of REC Opinion
14 Jun 2017
Further Information Favourable Opinion