Placebo-Controlled Study of ANB020 in Patient with Atopic Dermatitis
Research type
Research Study
Full title
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity upon House Dust Mite Skin Challenge in Patients Suffering from Moderate to Severe Atopic Dermatitis
IRAS ID
216042
Contact name
Graham Ogg
Contact email
Sponsor organisation
AnaptysBio Inc.
Eudract number
2016-002539-14
Duration of Study in the UK
0 years, 5 months, 9 days
Research summary
This is a phase II proof of concept, single centre study, investigating the safety, tolerability and activity of a single dose of ANB020 in patients with atopic dermatitis (AD) undergoing House Dust Mite (HDM) skin challenge.
Approximately 12 patients aged 18 years or over with moderate to severe AD will be recruited to take part in the study. Patients who meet inclusion and exclusion criteria and have signed an informed consent form will be assigned an enrolment number. All patients will be dosed with placebo followed by house dust mite (HDM) and saline skin challenge. Patients who have had a positive response to the HDM skin challenge will then receive a single dose of ANB020 followed by an HDM and saline skin challenge test administration. HDM and saline skin challenges will be delivered by intra-epidermal skin prick tests. Both placebo and study drug will be administered by intravenous (into a vein) infusions. All patients that receive study medication will be followed for 8 weeks (56 days) post dose of ANB020. Patients will have both in-patient clinic visits as well as site staff telephone contacts throughout the follow-up period.REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1959
Date of REC Opinion
13 Dec 2016
REC opinion
Further Information Favourable Opinion