Drogheda

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating targeted therapies for adult participants with moderate to severe Crohn's disease, a chronic condition causing severe inflammation in the digestive tract. This disease often leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. The study aims to assess the effectiveness and side effects of several targeted treatments, as current therapies may not work equally well for all patients or may lose effectiveness over time. This is a Phase 2a multicenter, randomized platform study enrolling around 540 adults across approximately 300 sites worldwide. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These therapies are administered either as injections under the skin or infusions into the vein, depending on the drug. Participants will be randomly assigned to one of the treatment groups. The study will involve regular visits to hospitals or clinics where participants receive their assigned treatments and are monitored throughout the study period. Participants will undergo medical assessments including blood tests and endoscopies to check the status of their disease and to monitor for any side effects. They will also complete questionnaires and keep a daily diary to track their condition. The main outcome measured is the percentage of participants who achieve endoscopic remission by week 12. The study involves careful safety monitoring and aims to provide detailed data on the treatments over the course of the trial.

Researchers are studying adults attending Irish hospitals with infectious diseases, including Covid-19, through the All-Ireland Infectious Diseases (AIID) Cohort. This multicenter, prospective, and ongoing observational study enrolls adult patients over 18 years old who seek infectious disease care. The study aims to collect detailed clinical, laboratory, and treatment data to better understand infectious diseases and their impact. Participants provide consent to use their routine clinical and laboratory data collected from medical records and electronic health systems. Data collected includes demographics, laboratory results related to infections such as HIV, tuberculosis, hepatitis C, and Covid-19, medication use, adherence, and clinical events including hospitalizations. Biological samples are also collected up to five times every six months for biobanking to support future research on host and pathogen factors. During the study, participants attend routine clinic visits where data and samples are collected. Researchers monitor and record clinical history, treatments, and laboratory findings. The main outcome is to establish a data-rich cohort over an average of one year. Ethical approval and informed consent are obtained, and data access is governed by strict guidelines to protect participant information. The duration of the cohort is unlimited, allowing long-term observation.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.

Researchers are evaluating the safety and effectiveness of MTX-463, an immunoglobin G1 monoclonal antibody targeting WISP1, in people with idiopathic pulmonary fibrosis (IPF). This Phase 2a randomized, double-blind, placebo-controlled study includes participants aged 40 years and older who meet specific diagnostic criteria and may be using approved IPF treatments such as pirfenidone or nintedanib. The study aims to measure changes in forced vital capacity (FVC) over 24 weeks to assess MTX-463's impact on lung function. Participants will be randomly assigned to receive either MTX-463 or a placebo through intravenous infusions every four weeks from Day 0 to Week 20. The treatment period concludes with an End of Treatment Visit at Week 24, followed by a Safety Follow-Up Visit at Week 28. Blood samples will be collected regularly to monitor safety, WISP1 levels, and drug presence, while lung function tests including FVC and lung perfusion imaging will be performed at set intervals. During the study, participants will visit the clinic for assessments at screening, baseline, and throughout the treatment and follow-up periods. These assessments include lung function tests, safety labs, and evaluation of treatment effects. Researchers will monitor participants closely to understand MTX-463's safety profile and its effect on lung function in IPF over the full 28 weeks of participation.