This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient. The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
LEO 138559 is an antibody given by injection just under the skin.
LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
LEO Pharma Investigational Site
Birmingham, Alabama, United States
LEO Pharma Investigational Site
Fountain Valley, California, United States
LEO Pharma Investigational Site
Los Angeles, California, United States
LEO Pharma Investigational Site
Doral, Florida, United States
LEO Pharma Investigational Site
Hialeah, Florida, United States
LEO Pharma Investigational Site
Markham, Ontario, Canada
LEO Pharma Investigational Site
Mississauga, Ontario, Canada
LEO Pharma Investigational Site
Peterborough, Ontario, Canada
LEO Pharma Investigational Site
Berlin, Germany
LEO Pharma Investigational Site
Dresden, Germany
...and 7 more locations
Change in EASI Score From Baseline to Week 16
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive and/or severe condition.
Time frame: Week 0 to Week 16
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Week 0 to Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.