Atopic Dermatitis

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months with Atopic Dermatitis

• Population: Infants and toddlers 3 months to < 24 months (post-natal)
• Study Condition: Participants must have a diagnosis of mild to severe atopic dermatitis (AD) covering ≥ 5% of the body, excluding the scalp.
• Study Design: This study is a Phase 3 study with a randomized, double-blind, 8-week period followed by a 48-week open-label (OL) period to evaluate tapinarof cream, 1% in pediatric participants with AD. Following screening, eligible participants will receive tapinarof cream, 1% or a vehicle cream once daily for 8 weeks. After this initial phase, participants will enter the 48-week open-label period. Throughout the study, a participant’s AD will be evaluated by trial physicians to determine if treatment should be continued during the OL period or if the participant’s AD has cleared and treatment can be discontinued.
• Reimbursement may be provided
  
  

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 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

• Population: Children aged 6 to less than 12 years old.
• Study Condition: Participants must have a diagnosis of moderate to severe atopic dermatitis and a documented history of inadequate response to treatment with medicated topical therapy for atopic dermatitis for at least 4 weeks
• Study Design: This study will assess the efficacy and safety of abrocitinib. Participants will be randomized 2:1 to receive either abrocitinib 100 mg AED QD oral suspension or a matching placebo.
• Reimbursement will be provided

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 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