Kurtzea

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the treatment outcomes of subcutaneous anifrolumab 120 mg once weekly as add-on therapy to antimalarials, with or without glucocorticoids (GCs), in patients with systemic lupus erythematosus (SLE) who have not previously used immunosuppressants or biologics. The study focuses on patients not in Lupus Low Disease Activity State (LLDAS) at enrollment and aims to describe clinical outcomes such as achieving DORIS remission, while also understanding GC tapering and withdrawal possibilities. This is a Phase 3, open-label, single-arm study. Approximately 275 participants aged 18 to 70 will receive anifrolumab subcutaneously once weekly for 52 weeks following a screening period of up to 35 days. Participants may increase their GC dose until week 4 based on investigator recommendation, then those on more than 5 mg/day GC at entry will attempt a taper to 5 mg/day over 12 weeks between weeks 5 and 40. Participants achieving DORIS remission for two visits will then attempt complete GC withdrawal with a 12-week taper. After week 41 until study end, no further GC dose reductions will occur. Following treatment, a 12-week safety follow-up is included for those not continuing anifrolumab. Participants will undergo assessments including clinical evaluations, laboratory tests, and questionnaires to monitor disease activity, remission status, and safety. Researchers will measure attainment of DORIS remission at week 52 as the primary outcome. Study evaluations will include ANA and other antibody testing, infection screening, HPV testing, and adherence to study procedures. The total study duration is approximately 69 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating whether different doses of the medicine called BI 3000202 can help adults with moderate to severe systemic lupus erythematosus (SLE). This phase II study is designed to find the best dose of BI 3000202 for people living with this condition. Participants must have a confirmed diagnosis of SLE with specific disease activity and antibody markers. Participants are randomly divided into five groups. Four groups receive varying doses of BI 3000202, while one group receives a placebo that looks like the real medicine but contains no active drug. All participants continue their usual SLE treatments during the study. The tablets are taken daily for one year. During the study, participants visit the study site regularly for health checkups and to monitor any side effects. Researchers measure the treatment's effectiveness by the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at week 32. The total participation time is a bit longer than one year, during which safety and health are closely observed and compared between groups.

Researchers are evaluating whether the medicine nerandomilast can slow lung changes in people aged 40 years or older who have at least one family member with pulmonary fibrosis. Pulmonary fibrosis involves scarring of lung tissue, making breathing harder, and early lung changes called interstitial lung abnormalities may lead to this scarring. Because having family members with pulmonary fibrosis increases risk, this study aims to find ways to prevent the condition from worsening. Participants are randomly assigned to one of two groups: one takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take a tablet twice daily for about 2 to 3 years. There is a 60% chance of receiving nerandomilast. The study includes regular visits more frequently during the first two years (about every 3 months) and then every 6 months, with phone calls every 3 months during the third year. During the study, doctors regularly test lung function and perform chest scans to monitor lung changes and treatment effects. They also check participants' overall health and watch for any side effects. The main outcome measured is the time to worsening of lung abnormalities over up to 164 weeks, comparing nerandomilast to placebo to see if it helps slow disease progression.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are investigating cardiotoxicity prevention methods in elderly cancer patients undergoing anti-tumor treatments. The trial compares two strategies: primary prevention using intensive cardiovascular monitoring with a cardio-onco-hematology team, and secondary prevention following current clinical practice where intensive monitoring is not routine. The main goal is to see if the primary prevention reduces all-cause mortality over mid-term and five years of follow-up. Secondary objectives include examining cardiovascular and oncological mortality, hospitalizations due to complications, tumor progression, and cost-effectiveness. Participants will be assigned to either intensive cardiovascular monitoring or standard care. Both groups have evaluations before chemotherapy, at three and six months, then annually for five years (eight visits total). Intensive monitoring includes physical exams, EKG, echocardiograms, biomarker tests, counseling on heart health, treatment optimization, quality of life assessments, and care coordination by a specialized team. The standard care group receives similar visit schedules with exams and performance status but cardiovascular care is managed by the oncologist. Some centers also perform cardiac MRI in a sub-study. Throughout the study, patients will undergo detailed assessments to track heart function, cancer progression, quality of life, and clinical events. Researchers will measure outcomes at two and five years to evaluate mortality and complications. The study enrolls 514 patients aged 65 and older with specific cancers including colon, breast, lymphoma, and myeloma. The follow-up includes regular visits and multidisciplinary care to monitor safety and effectiveness of the prevention strategies over time.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are investigating treatments for patients with coronary artery disease who have calcified nodules causing new lesions. This international, open-label, randomized trial compares two treatment approaches using percutaneous coronary intervention (PCI) after modifying the plaque with intravascular lithotripsy. The study aims to evaluate whether using a drug eluting balloon (DEB) is as effective or possibly better than a drug eluting stent (DES) in improving artery opening and reducing narrowing at 9 months. Participants receive PCI to treat their calcified nodules with intravascular lithotripsy followed by either a drug eluting balloon or a drug eluting stent. Both treatments are devices applied during the procedure to help keep the blood vessel open. The study follows patients after treatment to compare the late lumen loss and net luminal gain in the affected artery at 9 months. During the study, patients are monitored with imaging techniques such as optical coherence tomography or intravascular ultrasound to confirm lesion characteristics. Researchers measure artery opening and narrowing at 9 months to assess treatment effects. Participants must be available for follow-up visits including angiographic evaluation and provide informed consent. The trial enrolls adults with stable or acute coronary artery disease who have severe calcified lesions in vessels sized between 2.5 and 4 mm.