Atopic Dermatitis Clinical Trials in Raleigh, NC

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) 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. Read Less

The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B following SC injections, as monotherapy or as add-on therapy with dupilumab. The study will enroll patients with moderate to severe AD in 4 cohorts. There will be 2 Monotherapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. There will be 2 Add-on Therapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. Patients in the Monotherapy Cohorts will be treated with BSI 045B. Patients in the Add-on Therapy Cohorts will be treated with BSI-045B, concomitantly with steady-state dupilumab treatment. Patients in each of these 4 cohorts will initially be treated with a loading dose of BSI-045B given every week (QW) for 3 weeks. Thereafter, BSI-045B will be administered every 2 weeks (Q2W) and patients will receive their assigned dose of BSI-045B (300 mg or 480 mg) Q2W through Week 24. Read Less