DeBary

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating the efficacy and safety of enpatoran in adults with active skin symptoms of lupus erythematosus, including those with or without systemic lupus. This global, multicenter Phase 3 study focuses on participants with cutaneous lupus manifestations such as Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, and Acute Cutaneous Lupus Erythematosus. Participants with systemic lupus must meet specific classification criteria and have active cutaneous disease. Participants will be randomly assigned to receive either enpatoran or a placebo, both given orally twice daily for 24 weeks (from Day 1 to Day 168). Alongside these treatments, participants will continue to receive standard of care as recommended by their investigator. The enpatoran and placebo are administered as film-coated tablets. Visits occur every four weeks during the treatment period, with one televisit at Week 2. During the study, participants will be monitored regularly with assessments every four weeks over the 24-week treatment phase, followed by additional observation to reach a total study duration of up to 35 weeks. Researchers will measure skin disease improvement using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), focusing on the percentage of participants who achieve at least a 70% reduction in skin disease activity by Week 24. Safety and other health evaluations will also be conducted throughout the study period.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

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). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with placebo as treatment for adults aged 18 to 80 with high-risk asthma who currently do not qualify for biologic therapies. This Phase 2, randomized, double-blind, placebo-controlled study focuses on participants with mild-to-moderate asthma diagnosed for over a year, who have had at least one asthma exacerbation in the previous year. The goal is to better understand lunsekimig's effects in this specific asthma population. Participants will be randomly assigned to receive either subcutaneous injections of lunsekimig or placebo over approximately 52 weeks. Alongside this, they may continue using other asthma medications such as various inhaled treatments including fluticasone/salmeterol, budesonide/formoterol, budesonide/albuterol, or short-acting beta agonists. The study includes up to 18 visits throughout the treatment period, with some participants possibly continuing into a long-term safety (LTS) study lasting up to 60 weeks total. During the study, participants will undergo regular assessments to monitor asthma control, lung function, and the rate of asthma exacerbations. The primary measurement is the annualized rate of asthma exacerbation events from baseline up to 52 weeks. Safety and tolerability will also be closely observed. The total study duration for most participants will be around 64 weeks if they do not enter the LTS study. Researchers will gather data through clinical visits, lung function tests, and ongoing safety monitoring to evaluate the treatment's impact and participant health throughout the trial.

Researchers are evaluating the effects of Taplucainium Inhalation Powder (NOC-110) in adults aged 18 to 80 who have refractory or unexplained chronic cough lasting at least 12 months. This phase 2b study aims to assess the medicine's efficacy, safety, and tolerability compared to a placebo in a randomized, double-blind, controlled setting. The study will involve about 455 participants, with up to 1264 screened to identify eligible adults. Participants will receive either NOC-110 inhalation powder or a matching placebo once daily during the treatment period. The study includes a screening phase followed by approximately 13 weeks of participation, during which participants will use the assigned inhalation powder. The trial is designed to monitor how the treatments impact cough frequency and overall tolerability over this period. Throughout the study, participants will be closely monitored for changes in their 24-hour cough rates, measured from baseline to the end of treatment. Researchers will also assess safety and any side effects. Participants will provide informed consent and follow contraceptive guidance if applicable. The study includes detailed tracking of medical history, respiratory health, and other relevant factors to ensure participant safety and gather comprehensive data on treatment effects.