Safety, tolerability and blood levels of ONO-4685
Research type
Research Study
Full title
A randomised, multi-centre, double-blind, placebo-controlled, single ascending dose, multiple dose study to assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intravenous infusion doses of ONO-4685 in patients with plaque psoriasis (21-502)
IRAS ID
303525
Contact name
Mick Herdman
Contact email
Sponsor organisation
ONO Pharmaceutical Co., Ltd
Eudract number
2021-002151-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
ONO-4685 (the study medicine) is an experimental new treatment for diseases linked to problems with the immune system that cause inflammation, such as plaque psoriasis. ONO-4685 contains a protein called a ‘monoclonal antibody’, which is designed to attach to and block the activity of substances that may cause the immune system to be overactive. We hope that ultimately the study medicine will reduce skin inflammation and improve symptoms in people who have plaque psoriasis.
We’ll test single and repeated doses of ONO-4685, given by slow injection into a vein, in patients with psoriasis, aged 18–65. We aim to find out its side effects and blood levels, its effect on the immune system, and whether the body develops antibodies to it. We’ll also assess if it improves the symptoms of psoriasis.
The study is in 3 parts.
In Part A, we’ll give up to 90 psoriasis patients single doses of ONO 4685. We’ll start with a small dose and increase the dose as the study progresses. Participants will take up to 12 weeks to complete the study, make up to 9 outpatient visits, and stay on the ward for 4 nights in a row.
In Parts B and C, we’ll give up to 36 patients with psoriasis repeated doses of ONO 4685 once or twice weekly, over 4 weeks. Participants will take up to about 24 weeks to finish the study, make up to 16 outpatient visits, and stay on the ward for up to 4 nights in a row on 4 occasions.
A pharmaceutical company Ono Pharmaceutical Co., Ltd is funding the study.
The study is planned to take place at 2 centres in the UK.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0064
Date of REC Opinion
16 Mar 2022
REC opinion
Further Information Favourable Opinion