UCB9741 - First doses in humans; Version 1
Research type
Research Study
Full title
A phase I/IIA, randomized, placebo-controlled, single ascending dose (Part A, participant- and investigator-blind) and repeated-dose (Part B, participant-, investigator-, and sponsor-blind) study to investigate the safety, pharmacokinetics and efficacy of UCB9741 in healthy study participants (Part A) and in study participants with moderate-to-severe atopic dermatitis (Part B). HMR code: 20-507
IRAS ID
288620
Contact name
Nathalie De Beule
Contact email
Sponsor organisation
UCB Pharma Biopharma SRL
Eudract number
2020-003639-41
Duration of Study in the UK
1 years, 0 months, days
Research summary
UCB9741 (the study medicine) is a medicine for treating atopic dermatitis, a type of eczema associated with inflammation of the skin, and which causes the skin to become itchy, red, dry and cracked. The study medicine contains a large protein called a ‘monoclonal antibody’, which is made specifically for use in humans. It’s designed to attach to and block the activity of substances that play a role in increased inflammation. We hope that the study medicine will be more effective at reducing the symptoms of atopic dermatitis than existing treatments.
We’ll test doses of the study medicine, given as a slow injection into a vein or an injection under the skin, to assess its safety, how well its tolerated, blood levels, after dosing, its effect on the immune system, and whether the body makes antibodies against it. Also, we’ll assess if it improves symptoms in participants with atopic dermatitis.
The study is in 2 parts. In Part A, we’ll give up to 84 healthy volunteers single doses of the study medicine by slow injection into a vein or an injection under the skin. The study medicine has never been given to humans before, so we’ll start with a small dose, and increase it as the study progresses. In Part B, we’ll give up to 75 participants with moderate-to-severe atopic dermatitis repeated doses of UCB9741 by slow injection into a vein.
Participants will take up to 16 weeks (Part A) or 26 weeks (Part B) to complete the study. They’ll make up to 14 outpatient visits and stay on the ward for up to a total of 5 nights.
A pharmaceutical company (UCB Biopharma SRL) is funding the study.
The study will take place at 1 centre in the UK (Part A), London, and multiple centres elsewhere in Europe (Part B).
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1048
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion