A SAD MAD study of LEO 138559
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single and multiple ascending dose trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis
IRAS ID
239074
Contact name
Jim Bush
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2017-003701-18
Clinicaltrials.gov Identifier
18/NW/0004, REC
Duration of Study in the UK
1 years, 5 months, 16 days
Research summary
The study drug (LEO 138559) is an investigational drug which is being developed by the sponsor as a potential treatment for atopic dermatitis.
Atopic dermatitis is a type of eczema where the skin becomes itchy, red, dry and cracked and lasts for long-term. What causes atopic dermatitis is not well known but high levels of a protein called interleukin 22 (IL-22) in the body is believed to play a role in developing the disease.
Many people with atopic dermatitis improve their condition and relieve their symptoms using moisturising treatments and drugs such as corticosteroids, lifestyle changes and phototherapy. However for about one-fifth of people with moderate to severe forms of atopic dermatitic these treatments are not as effective especially in the long-term, and currently there is no cure for the disease.
The study drug works to reduce the symptoms of atopic dermatitic by decreasing the levels of IL 22 in the body. The study drug could therefore be used to treat people with moderate to severe atopic dermatitis in the future.
This study is the first time that the study drug is being given to humans.
Up to 68 participants will be participating in this multiple-site study (up to 36 in Part 1 and up to 32 in Part 2)
Part 1 will include 6 cohorts of healthy subjects. Participants in this cohort will receive a single dose of study drug/ placebo.
Part 2 will include 3 cohorts of health subjects and 1 cohort of atopic dermatitis patients. Participants in this cohort will receive 5 once-weekly doses of study drug/ placebo.
Participation in the study is expected to last up to 17 weeks in Part 1 and up to 22 weeks in Part 2.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0004
Date of REC Opinion
27 Feb 2018
REC opinion
Favourable Opinion