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. Part A will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. Both parts (Part A and Part B) will consist of 4 periods:
o Screening Period of up to 6 weeks
o Induction Period of up to approximately 16 weeks
o Maintenance Period of up to approximately 36 weeks
o Post-treatment Follow-up Period
This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.
This is a Phase 3, 52-week, multi-center, double-blind, parallel-group, randomized withdrawal (RW), dose-up titration (DUT) extension study investigating the safety, tolerability, efficacy and durability of response of ritlecitinib (50 mg QD and 100 mg QD) in adult and adolescent (where permitted) participants with nonsegmental vitiligo following their participation in pivotal Study B7981040. The maximum duration of study participation is approximately 14 months, including a screening period up to 25 days, a 52-week treatment period, and a 4-week follow-up period.
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared to active control (ustekinumab) in children and adolescents (from 6 to <18 years of age) with moderate to severe plaque PSO. This study will consist of the following periods:
• Screening Period: up to 5 weeks
• Initial Treatment Period: 16 weeks
• Maintenance Period: 32 weeks
• OLE Period: 104 weeks
• SFU Period: 20 weeks after final dose of IMP
After the Screening Period of up to 5 weeks, eligible study participants will be randomized in a 2:1 ratio of bimekizumab to ustekinumab. Study participants will participate in a 16-week double-blinded Initial Treatment Period and continue into a 32-week double-blinded Maintenance Period. After completion of the Maintenance Period, study participants will be offered the opportunity to continue in a 104-week open label extension period and receive bimekizumab.
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.
This is a randomized, double-blind, parallel group, vehicle-controlled phase to evaluate the efficacy and safety of diacerein 1% ointment applied topically once daily for 8 weeks for the treatment of adult and pediatric (age ≥ 6 months) patients with generalized EBS. The duration of study participation is anticipated to be approximately ~16 to 20 weeks per patient consisting of a Screening Period of up to 4 weeks, a Treatment Period of 8 weeks and a No Treatment Follow-up Period of 8 weeks. Patients that complete this portion of the study will be eligible to participate in an open-label, 24-week extension phase to evaluate the long-term safety of diacerein 1% ointment for the treatment of generalized EBS.
This is a non-interventional, prospective, multinational, post-marketing, observational study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with PN. This study will be conducted globally and will collect data available from patients' medical files and other items routinely collected during disease management in clinical practice and PROs related to disease, work productivity, and QoL.
This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with Non-Segmental Vitiligo who are eligible for systemic therapy. This study is comprised of a 35-day Screening Period; a 48-week placebo-controlled, double-blinded treatment period (Period A); a 112-week open-label extension period (Period B); and a 30-day follow-up period. In Period A, adult and adolescent subjects who meet eligibility criteria will be randomized 2:1 to receive daily oral doses of upadacitinib 15 mg or matching placebo. Subjects who complete Period A will continue into Period B and will receive open-label upadacitinib 15 mg.
The purpose of this research study is to study if the investigational drug, MK-6194, is safe and effective to treat adults with non-segmental vitiligo. In this study, MK-6194 or placebo administration will occur every two weeks or every four weeks to evaluate how well MK-6194 may treat non-segmental vitiligo. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 14 days for safety follow-up. Eligible participants will be randomized 1:1:1 to receive MK-6194 every two weeks, every four weeks, or receive placebo.