The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life. LEO 138559 is also called "Temtokibart".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
LEO 138559 given by injection just under the skin
Placebo given by injection just under the skin
LEO Investigational Site
Fountain Valley, California, United States
LEO Investigational Site
Los Angeles, California, United States
LEO Investigational Site
San Francisco, California, United States
LEO Investigational Site
Hialeah, Florida, United States
LEO investigational site
Indianapolis, Indiana, United States
Percent Change in Eczema Area and Severity Index (EASI) Score
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
Time frame: From baseline to Week 16
Number of Treatment-emergent Adverse Events (TEAEs)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP.
Time frame: From baseline (Week 0) to Week 16
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LEO investigational Site
New Albany, Indiana, United States
LEO Investigational Site
Ann Arbor, Michigan, United States
LEO Investigational Site
New York, New York, United States
LEO Investigational Site
Raleigh, North Carolina, United States
LEO Investigational Site
Cincinnati, Ohio, United States
...and 63 more locations