Bowling Green

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 studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are investigating the long-term safety and effectiveness of APG777, a treatment for moderate-to-severe atopic dermatitis (AD), in patients who have already completed an initial APG777 study. This phase 2, multicenter, double-blind study focuses on those who may benefit from extended treatment with APG777 to better understand its ongoing effects and safety over time. The study includes three main periods: a screening visit that occurs at the end of the previous study's maintenance period, an extended treatment period where participants receive APG777 subcutaneous injections every 12 or 24 weeks, and a post-treatment follow-up period. Participants will continue using their chosen non-medicated moisturizer from the previous study throughout this extension. During the study, participants' health and response to treatment will be closely monitored, including tracking any treatment-emergent adverse events for up to three years. Researchers will assess the long-term safety and efficacy of APG777 while ensuring participants remain compliant with study protocols. This ongoing observation aims to provide detailed information on how APG777 affects patients over extended use.

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of the Zona Plus handgrip therapy device compared to an auditory relaxation therapy in people with elevated blood pressure or hypertension who are not currently taking blood pressure medications. This multi-center, randomized clinical trial includes subjects aged 22 and older who have confirmed elevated blood pressure and meet specific vision, hearing, and hand strength requirements. The study aims to see how these therapies affect blood pressure over time, with a focus on comparing changes in seated cuff systolic blood pressure after 10 weeks of treatment. Participants are randomly assigned to either use the Zona Plus device for isometric handgrip exercises or to listen to relaxing music through a mobile app. The Zona Plus device includes an electronic memory to track compliance, while those in the music group keep a diary to record their adherence. Some participants may switch from the music therapy to the Zona Plus device after their sixth study visit. Subjects with systolic blood pressure between 140 and 149 mmHg receive additional monitoring with three extra study visits. Overall, participation can last from 3 to 8 months depending on individual monitoring needs. During the study, participants undergo blood pressure measurements, training on the study device, and regular clinic visits. Those using the Zona Plus device have their usage electronically monitored, and all participants document their compliance either electronically or in diaries. The main outcome measured is the change in mean seated cuff systolic blood pressure from baseline after 10 weeks. Safety and adherence are closely followed, especially for participants with higher baseline blood pressure. The study includes ongoing monitoring and follow-up visits to assess treatment effects over the full study period.

Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib (TAK-279) works in adults with active PsA, considering their prior treatment experiences with specific medications. The study is a Phase 3 trial that compares zasocitinib to a placebo in participants who have or have not been treated with biologic medicines. Participants will receive either zasocitinib tablets or a matching placebo. The study is randomized, double-blind, and placebo-controlled. Treatment will continue with monitoring over a period of up to 60 weeks to assess the effects and safety of zasocitinib. During the study, participants will undergo assessments of joint and skin symptoms, including tender and swollen joint counts and evaluations of psoriatic skin lesions. Researchers will measure how many participants achieve a significant improvement in their arthritis symptoms by Week 16. Safety and response will be monitored throughout the study period, with detailed follow-up visits and evaluations to understand the treatment's impact over time.

This trial investigates treatments for children aged 2 to less than 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib, a drug approved for patients 12 years and older, with subcutaneous dupilumab, focusing on safety, adverse events, and changes in disease activity. The study is phase 3, open-label, and efficacy-assessor-blinded, enrolling about 675 participants worldwide who require systemic anti-inflammatory treatment beyond topical therapies. Participants will be randomly assigned to receive upadacitinib daily as oral tablets or oral solution for 160 weeks, or dupilumab by injection according to its approved dosing every 2 or 4 weeks for 52 weeks. Participants are stratified by disease severity, age, and previous treatment response. After completing treatment, follow-up visits occur for 30 days after upadacitinib and at least 12 weeks after dupilumab. The trial may involve more treatment visits than standard care. Throughout the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor disease severity and side effects. Researchers measure the percentage of participants achieving significant improvement in eczema severity by week 16 and track adverse events up to about week 172. This careful monitoring helps evaluate the safety and efficacy of the treatments over the long term.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.