Atopic Dermatitis

Below is a list of our atopic dermatitis studies that are currently enrolling.

 

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

• Population: Patients aged 6 months to less than 18 years
• Study Condition: Moderate-to-Severe Atopic Dermatitis (AD)
• Study Design: This is a randomized, double-blind, placebo-controlled, Phase 3 study to assess the efficacy, safety and pharmacokinetics of lebrikizumab in participants 6 months to <18 years of age with moderate-to-severe AD. Subjects will be randomized in a 2:1 ratio to receive either lebrikizumab or placebo. Subjects will attend 12 clinic visits for up to 30 weeks. Participants who complete this trial may be given the option to enroll into a long-term extension study where lebrikizumab will be provided.
• Compensation for time and travel may be provided 

 

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects with Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

• Population: Patients aged 12 years to less than 18 years
• Study Condition: Moderate-to-Severe Atopic Dermatitis (AD)
• Study Design: This is a randomized, double-blind, placebo-controlled, Phase 3 study to assess the efficacy, safety and pharmacokinetics of rocatinlimab in participants 12 years to <18 years of age with moderate-to-severe AD. Subjects will be randomized in a 2:1 ratio to receive either rocatinlimab or placebo. Subjects will attend 16 clinic visits for up to 72 weeks. Participants who complete this trial may be given the option to enroll into a long-term extension study where rocatinlimab will be provided.
• Compensation will be provided

 

Atopic Dermatitis: Comparison of Safety and Assessor Blinded Efficacy of a Study Drug to Dupilumab in Adult and Adolescent Subjects

• Population: Patients 12 years to less than 65 years old who weigh at least 40 kg
• Study Condition: Moderate to Severe Atopic Dermatitis
• Study Design: This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate a study drug compared with dupilumab, as monotherapy, in adolescents and adult subjects who have inadequate response to systemic therapy. The study will consist of a 35-day Screening Period; Period 1, a 16-week randomized, open-label, efficacy assessor blinded treatment period for all subjects, and a 30-day or 12-week follow-up visit for subjects on the study drug and dupilumab respectively, who will not enter the Period 2; Period 2, a 16-week open-label, efficacy assessor blinded extension period for those subjects with a < EASI 75 response at Week 16 (total duration 32 weeks) and a 30-day follow-up visit.
• Compensation for study-related expenses may be provided

 

Please contact Dr. Veronica Emmerich for more information regarding ongoing atopic dermatitis studies. 

 

Email: emmerich@musc.edu

Phone: (843) 876-0110