Phillip

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.

Researchers are evaluating the safety, tolerability, drug behavior, and early effects of intralesional FLD-103 in adults with nodular basal cell carcinoma BCC, a type of skin cancer. This Phase 1 trial aims to find a safe dose for future studies and to see if FLD-103 can reduce tumor size. The main questions are about FLD-103s safety, how it moves through and clears from the body, and whether it shrinks tumors. Participants will receive either a single ascending dose SAD or multiple ascending doses MAD of FLD-103 injected into the lesion. Single doses range from 0.5 to 5 mgmL with volumes based on lesion size. Multiple doses are given once weekly for four weeks, with some groups receiving fixed volumes. The study has several dose levels to determine the maximum tolerable dose. During the trial, participants will visit the clinic the day after dosing and weekly for up to four weeks for checkups and tests. Researchers will monitor adverse events and local skin reactions from enrollment until study end up to 36 days for single dose groups and 57 days for multiple dose groups. Blood levels of FLD-103 will be measured to understand how much enters the bloodstream and how long it stays. The total participation lasts up to about two months depending on the dosing group.

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.