Eczema (Atopic 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 the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

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 studying DCY636, a new drug, to understand its safety, how it behaves in the body, and its immune effects in both healthy adults and adults with moderate to severe atopic dermatitis. This early phase 1 study aims to gather important information to support further testing of DCY636 in the future. The study is randomized, placebo-controlled, and blinded to ensure reliable results. The trial has two parts Part 1 involves healthy participants receiving single ascending doses of DCY636 or placebo across several dose levels. Part 2 includes participants with moderate to severe atopic dermatitis who receive multiple doses of DCY636 or placebo. Each group is carefully monitored to assess safety and drug behavior at different dose levels. Participants will be closely observed throughout the study, which lasts up to approximately 202 days for healthy participants and 301 days for those with atopic dermatitis. Researchers will monitor adverse events, drug levels, immune responses, and skin condition scores. Regular assessments include physical exams, lab tests, and questionnaires to track safety and how the drug affects the body over time.

Researchers are evaluating the long-term safety and effectiveness of Afimkibart also known as RO7790121 in adults with Atopic Dermatitis who participated in earlier Afimkibart clinical trials. This Phase 2 extension study focuses on participants who previously responded to Afimkibart treatment, aiming to gather extended data over several years. Participants will receive Afimkibart through subcutaneous injections according to a schedule outlined in the study protocol. The study is non-randomized and involves parallel groups, with all participants receiving the active drug. The treatment and follow-up periods can last up to six years to assess long-term outcomes. Throughout the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment IGA, patient questionnaires on eczema symptoms and quality of life POEM and DLQI, and blood tests to measure drug levels and immune response. Researchers will monitor adverse events and antibody development against Afimkibart. Participation involves ongoing evaluations and monitoring over the extended study duration.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

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 treatments 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.

This research aims to evaluate the long-term safety and effectiveness of liquid abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. The study is a Phase 3, open-label trial enrolling approximately 500 participants globally, including those who have previously completed abrocitinib studies and those new to this treatment. The study duration extends up to 2 years or until the medicine becomes commercially available, whichever comes first. Participants will receive abrocitinib oral suspension throughout the study. The trial enrolls two groups an extension cohort of children aged 2 to under 12 years who have completed prior abrocitinib studies, and a de novo cohort of children aged 6 to under 12 years who have not been in previous abrocitinib trials. Both groups may use topical medications alongside the study drug as needed. During the study, participants will be regularly assessed for safety by monitoring adverse events, laboratory abnormalities, and other health measures. Researchers will evaluate skin condition improvements using various scales such as the Validated Investigators Global Assessment vIGA, Worst Itch Numerical Rating Scale WI-NRS, and Eczema Area and Severity Index EASI. Quality of life and other patient-reported outcomes will also be tracked. The study includes follow-up to track treatment effects and safety over the full 24 months.

Researchers are evaluating the safety and effectiveness of a gel called VC005 in adults with mild to moderate atopic dermatitis. This phase II clinical trial is randomized, double-blind, and vehicle-controlled, meaning participants receive either the gel or a placebo without knowing which one. The study is conducted at multiple centers and sponsored by Jiangsu vcare pharmaceutical technology co., LTD. Participants are assigned to one of four groups three different doses of VC005 gel or a placebo gel. All treatments involve local topical application directly to the affected skin areas. The study compares these groups in parallel to assess how the gel affects the severity and extent of eczema over a 4-week period. During the study, participants will be evaluated for changes in their eczema severity using the Eczema Area and Severity Index EASI at baseline and after 4 weeks. The researchers will monitor participants closely for any side effects or safety concerns. The study is designed for adults aged 18 years and older, and participants must meet specific diagnostic criteria for atopic dermatitis. The total study duration extends until February 2027.