DeBary

Researchers are evaluating VENT-03 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.

Researchers are evaluating dotinurad, an oral drug, to lower serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors XOI or whose uricase treatment has failed. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the drugs effectiveness and safety in this specific population. The primary goal is to see how many participants achieve a serum uric acid level below 6.0 mgdL at 24 weeks. Participants will be divided into two groups. One group will take dotinurad for 36 weeks, split into a 24-week initial period followed by a 12-week continuation. The other group will take a placebo for the first 24 weeks and then switch to dotinurad for the final 12 weeks. Dotinurad is given as an oral tablet, while the placebo capsules contain inactive ingredients. This design allows comparison of the drug against placebo and later observation of dotinurads effects. During the study, participants will have their serum uric acid measured at various points, especially at weeks 16, 20, 24, and up to week 40. Researchers will monitor treatment-emergent adverse events throughout the study period. Participants will be followed from screening through treatment and safety assessments, with the primary focus on uric acid levels at week 24. The total study duration for each participant covers screening and up to 40 weeks of follow-up.

Researchers are studying enpatoran in adults with active skin symptoms of lupus erythematosus, with or without systemic involvement. This global, multicenter Phase 3 trial aims to assess the effectiveness and safety of enpatoran compared to a placebo over 24 weeks. Participants must have certain types of cutaneous lupus, including discoid, subacute, or acute forms, and may also have systemic lupus erythematosus SLE. The study is sponsored by EMD Serono Research & Development Institute, Inc.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the effects of switching from combustible cigarettes to a Tobacco Heating System THS in adults with COPD and chronic bronchitis. This randomized study aims to show clinical benefits in symptoms such as cough frequency and shortness of breath, as well as lung function and exercise ability measured by a six-minute walk test. The study focuses on how patients feel and function when switching to THS compared to continuing cigarette smoking. Participants are randomly assigned to either continue smoking cigarettes or switch to using the THS freely without flavor restrictions. The study lasts for 24 weeks, during which the participants use their assigned product as they wish. Researchers compare changes in symptoms, lung function, cough severity, and exposure to harmful substances between the two groups over this period. Throughout the 24 weeks, participants undergo various assessments including cough frequency monitoring, lung function tests, quality of life questionnaires related to cough, and measurements of nicotine and carbon monoxide exposure. These evaluations occur at multiple time points such as weeks 1, 4, 12, and 24. The study tracks symptom changes, respiratory function, and overall health status while ensuring safety monitoring and adherence, providing a comprehensive view of the effects of switching products for people with COPD.