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 Study of Upadacitinib in Adult Participants with Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

• Population: Adult subjects ≥ 18 years of age and < 64
• Study Condition: Moderate to severe atopic dermatitis (AD) and inadequate response to dupilumab after at least 6 months of current use
• Study Design: This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.
• Compensation may be provided for study participation

  

A Study of Upadacitinib Compared to Dupilumab in Pediatric Subjects with Moderate-to-Severe Atopic Dermatitis (START UP)

• Population: Pediatric subjects 6 years of age and < 12
• Study Condition: Moderate to severe atopic dermatitis (AD) for at least 6 months.
• Study Design: This is a Phase 3, open-label, efficacy-assessor-blinded Study, comparing the safety and efficacy of upadacitinib to dupilumab in children from 6 to less than 12 years of age with moderate to severe AD who are candidates for systemic therapy for AD. The study consists of a 35-day Screening Period; a 16-week randomized, open-label, efficacy assessor blinded treatment period for all subjects; an open-label period lasting up to week 52 for subjects in dupilumab arm; an open-label period lasting up to week 160 for subjects assigned to upadacitinib; and a 30-day follow up visit/call after the last dose is administered for upadacitinib or dupilumab.
• Compensation may be provided for participation.

A study to evaluate the efficacy and safety of subcutaneous amlitelimab on background topical corticosteroids therapy in participants aged 12 years and older with moderate-to-severe AD who have had an inadequate response to prior biologic therapy or an oral JAK inhibitor

• Population: Patients aged 12 years and older
• Study Condition: Moderate-to-Severe Atopic Dermatitis (AD)
• Study Design: This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.
• Compensation will be provided

A TWO-PART, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

• Population: Patients aged 18 years and older
• Study Condition: Moderate-to-Severe Atopic Dermatitis (AD)
• Study Design: This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of APG777 in adult patients with moderate-to-severe atopic dermatitis. Both parts (Part A and Part B) will consist of 4 periods:
  • Screening Period of up to 6 weeks
  • Induction Period of up to approximately 16 weeks
  • Maintenance Period of up to approximately 36 weeks
  • Post-treatment Follow-up Period:
    • Up to approximately 48 weeks for patients who completed the Maintenance Period, representing up to approximately 52 weeks from the last dose date of study drug.
    • Up to approximately 52 weeks from the last dose date of study drug for patients who do not enter the OLE or who terminated early.
• Compensation may be provided

 

Please contact Courtney Rowley for more information regarding ongoing atopic dermatitis studies. 

Email: rowle@musc.edu

Phone: (843) 792-9784