Dermatitis

Researchers are evaluating SYX-5219 in a multi-part, first-in-human Phase 1 study involving healthy volunteers and people with moderate to severe atopic dermatitis (AD). The study aims to determine the safety, tolerability, and levels of SYX-5219 in blood and urine when given in different dosing schedules. This includes single ascending doses, multiple ascending doses, and multiple dose administrations in participants with AD. The study has three parts: Part 1 involves single ascending doses and a food effect evaluation in healthy volunteers, with doses given once on Day 1 and again after a washout period. Part 2 involves multiple ascending doses given once or twice daily to healthy volunteers over a defined period. Part 3 enrolls participants with AD who receive SYX-5219 or placebo twice daily for up to 42 days. Each part includes randomization and placebo control to compare effects. Participants will undergo safety and exploratory efficacy assessments during and after treatment, including monitoring adverse events up to 10 days after dosing in Part 1, 14 days after the last dose in Part 2, and up to Day 56 in Part 3. Blood and urine samples are collected at multiple timepoints to measure SYX-5219 levels. The study includes follow-up visits to monitor participant health and drug effects for several weeks after treatment ends.

Researchers are evaluating SM17, a monoclonal antibody given by subcutaneous injection, for treating adults with moderate to severe atopic dermatitis who have not responded well or cannot tolerate certain topical treatments. This phase 2 clinical trial aims to study the effectiveness, safety, how the body processes the drug, and the immune response to SM17. The study also seeks to find the best dosing schedule for future research. Participants are randomly assigned to one of four groups receiving different doses of SM17 or a matching placebo. The treatment lasts 16 weeks during a double-blind phase, followed by an optional 4-week open-label period where all participants may receive SM17 depending on their skin condition scores. Dosages and intervals vary between groups, and participants receive subcutaneous injections throughout the study. After the treatment, a safety follow-up occurs 4 weeks after the last dose. During the study, participants will have regular assessments of their skin condition using clinical evaluations and patient questionnaires. Blood samples will be collected to monitor drug levels, immune response, and biomarkers. Safety tests, including lab work, will be performed regularly. The main outcome measured is the Eczema Area and Severity Index (EASI) at Week 16, with multiple other measures assessed at various timepoints up to Week 24. Total participation spans screening, treatment, and safety follow-up periods lasting several months.

Researchers are evaluating how different doses of galvokimig compare with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition. This Phase 2 study aims to understand the relationship between the dose given and its effects on the condition, focusing on safety, how the drug moves through and acts in the body, and its overall impact on the disease. Participants will be randomly assigned to receive one of three different doses of galvokimig or a placebo during the initial treatment period. After 16 weeks, participants will either continue on the same dose or switch to a modified dose based on the study plan. Galvokimig and placebo are given as injections, and the study is designed to be double-blind, meaning neither participants nor researchers know who receives which treatment during the initial phase. During the study, participants will be regularly evaluated for changes in their eczema severity, itch intensity, and overall response to treatment using specific scales like the Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Rating Scale (PP-NRS). Safety is closely monitored through reports of adverse events up to week 58. The study lasts at least 16 weeks with ongoing assessments to track treatment effects and safety over time.

Researchers are evaluating the effectiveness and safety of GX-03, a topical ointment, in adults with moderate to severe atopic dermatitis, also known as eczema. This Phase 2, randomized, double-blind, vehicle-controlled study plans to enroll up to 120 adults aged 18 to 80, with the possibility of expanding to 200 based on interim review by an Independent Data Monitoring Committee. The study focuses on improvements in disease severity, itch, and patient-reported eczema symptoms. Participants will be randomly assigned to receive either GX-03 ointment or a matching vehicle control ointment. The assigned treatment will be applied topically to affected skin areas at least twice daily for eight consecutive weeks. The study includes an adaptive design, with an interim assessment after about 50 participants complete the 8-week treatment or withdraw early, which could lead to continuation, expansion, or stopping of enrollment based on pre-set criteria. During the study, participants will attend visits at baseline, Week 4, and Week 8 for assessments using validated tools such as the Investigator Global Assessment, Eczema Area and Severity Index, Peak Pruritus Numeric Rating Scale, and Patient-Oriented Eczema Measure. Safety will be monitored through adverse event reporting, medication reviews, and weekly safety check-ins. The primary outcome is the change in Investigator Global Assessment at Week 8, and total participation will last for the 8-week treatment period.

Researchers are conducting a first-in-human trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of the drug DCY636. The study includes both healthy volunteers and participants with moderate to severe atopic dermatitis (AD), aiming to support further clinical development of DCY636. This randomized, placebo-controlled, double-blind study is divided into two parts to carefully assess different participant groups. The study involves multiple dose levels of DCY636 administered to healthy participants in Part 1 and to participants with moderate to severe AD in Part 2. Participants are randomly assigned to receive either DCY636 or a placebo, with dose escalation in healthy volunteers followed by multiple dosing in AD participants. The trial monitors responses across several cohorts with varying doses to understand the drug's behavior and effects. Participants will undergo regular monitoring for adverse events and serious adverse events over approximately 202 days for healthy volunteers and 301 days for those with AD. Assessments include pharmacokinetic parameters like maximum concentration and area under the curve of DCY636, as well as testing for anti-drug antibodies. The study tracks safety, drug effects, and immune responses throughout the trial duration to inform future research and development.

Researchers are evaluating the long-term safety and effectiveness of Afimkibart (also called RO7790121) in adults who have atopic dermatitis and previously took part in earlier Afimkibart clinical trials. This Phase 2 extension study focuses on participants who responded to Afimkibart in the parent study and continued follow-up through the Week 36 visit. Participants will receive Afimkibart as subcutaneous injections following a schedule defined in the study protocol. Both study groups receive the same treatment to monitor ongoing effects over a period of up to six years. This extension allows researchers to collect long-term data on the medication’s impact on eczema severity and quality of life. During the study, participants will complete various assessments including the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Dermatology Life Quality Index (DLQI), and Participant-Oriented Eczema Measure (POEM). Blood samples will be collected to measure Afimkibart levels and antibody responses at multiple timepoints. Safety will be closely monitored by tracking adverse events from baseline through up to six years of follow-up.

Researchers are studying the long-term safety and effects of APG777 in adults with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a prior APG777 study. This Phase 2, multicenter, double-blind extension study aims to understand how well APG777 works and how safe it is when used over a longer period in patients who might benefit from continued treatment. The study includes three periods: a screening visit aligned with the end of the parent study's maintenance phase, an extended treatment period, and a post-treatment follow-up phase. Participants who met certain response criteria and did not use rescue medication in the parent study will continue with the same dosing schedule of APG777 injections. Those who did not meet these criteria or used rescue medication will be assigned to an open-label escape arm and receive APG777 according to a set dosing regimen. Treatment involves subcutaneous injections of APG777 every 12 or 24 weeks. Participants will be closely monitored throughout the study, which may last up to three years. Researchers will evaluate treatment-emergent adverse events, measure improvements in eczema severity using the Eczema Area and Severity Index (EASI), assess skin clearance via Investigator Global Assessment scores, and track itch severity using a numeric rating scale. Use of rescue therapy, treatment discontinuations related to adverse effects, and serum drug levels will also be recorded. The study aims to track long-term safety and ongoing benefits of APG777 in this patient group.

This research aims to evaluate the long-term safety and effectiveness of CM512 in adults with atopic dermatitis who have previously completed treatment in a parent CM512 study. The study is open-label and conducted at multiple centers, focusing on patients with this skin condition to gather extended data on the investigational treatment. Participants will receive CM512 through subcutaneous injection during the study. The design includes multiple experimental groups, and the study period spans up to 52 weeks, allowing researchers to observe long-term effects after prior treatments in earlier studies. This phase 2 study does not use blinding, and participants are randomized among the groups. During the study, participants will be monitored for adverse events and other safety measures for up to one year. Researchers will collect data on the treatment's impact and any side effects, ensuring thorough evaluation. Participants must have completed earlier parts of the CM512 parent studies to join, and they will be followed closely throughout the study duration which ends in December 2027.

Researchers are evaluating the long-term safety and effectiveness of abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. This Phase 3, open-label study will include participants who have previously completed other abrocitinib studies as well as children who have never participated in such studies. The trial aims to better understand how this treatment works over a period of up to 2 years or until the medication becomes commercially available. All participants will receive abrocitinib oral suspension. The study includes two groups: an extension cohort of up to 320 children who completed previous abrocitinib studies, and a de novo cohort of approximately 180 children aged 6 to under 12 years who have not received abrocitinib before. The intervention will be given alongside topical medications as needed, and the study will monitor both safety and treatment response during this time. During the study, participants will undergo regular assessments that include monitoring for treatment-emergent adverse events, serious side effects, and reasons for discontinuation. Researchers will also measure clinical responses using tools such as the Investigator's Global Assessment, itch rating scales, eczema severity indexes, and quality of life questionnaires. Laboratory tests and vaccination responses will be tracked, and data will be collected throughout the 24-month study period to evaluate long-term effects and safety.

Prurigo nodularis (PN) is a skin condition marked by intensely itching nodules that cause uncontrollable scratching and skin injuries. Researchers are studying the long-term use of dupilumab (Dupixent®) in adults aged 18 and older with moderate-to-severe PN in a real-world setting in Germany. The study aims to describe the effectiveness and safety of dupilumab treatment and understand patient-reported outcomes over time. Participants in this non-interventional study receive dupilumab as prescribed by their treating physician according to standard medical practice. The study observes patients who start dupilumab treatment either at the beginning of the study or within the previous 7 days. The observational period lasts up to 2 years, with assessments at baseline, 1 month after starting treatment, and then every 3 months during the first year, followed by every 6 months during the second year. During the study, participants will have various evaluations, including medical history, current and previous treatments, biomarker and laboratory tests if available, and several patient-reported questionnaires on disease control, quality of life, itch severity, sleep, and psychological well-being. Researchers will monitor treatment patterns, dosing changes, discontinuations, adverse events, and the overall long-term safety and effectiveness of dupilumab. The main outcomes include improvements in disease severity and itch reduction at 6 months, with ongoing assessments throughout the study period.