Sremska Kamenica

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the efficacy and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in people with recurrent or metastatic RM HPV-negative head and neck squamous cell carcinoma HNSCC. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants who have not responded to prior anti-PD-1PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The goal is to see if adding ficlatuzumab improves survival outcomes in this patient group. Participants are assigned to one of three groups two groups receive different doses of intravenous ficlatuzumab plus cetuximab on days 1 and 15 of each 28-day cycle, while the third group receives a placebo plus cetuximab on the same schedule. The study will enroll about 410 participants and compare progression-free survival and overall survival among these groups. Treatment cycles continue until disease progression or other study endpoints. During the study, participants will undergo regular imaging scans CT or MRI to assess tumor response every 8 weeks during the first year, then every 12 weeks in years 2 and 3, and every 6 months thereafter. Researchers will monitor safety, quality of life, and immune responses, including antidrug antibodies. The study period spans approximately 44 months with ongoing evaluations from randomization until death or last response assessment.

Researchers are evaluating KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

Researchers are evaluating telisotuzumab adizutecan, alone or combined with osimertinib, compared to standard care in adults with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer NSCLC. The study aims to assess adverse events and changes in disease activity, enrolling approximately 490 adults worldwide. It includes two phases phase 2 to test doses and combinations, and phase 3 to compare the recommended dose to standard care. During phase 2, participants receive one of two intravenous doses of telisotuzumab adizutecan, either alone or with oral osimertinib. In phase 3, participants receive the recommended phase 3 dose of telisotuzumab adizutecan or standard of care. The entire study lasts about 69 months, with participants undergoing assigned treatments according to their groups. Participants will attend regular visits at approved hospitals or clinics for medical assessments, blood tests, questionnaires, and monitoring of side effects. Researchers will measure objective response and progression-free survival through blinded independent central review over the study duration. Quality of life and lung cancer symptoms will also be evaluated. Safety and overall survival will be tracked throughout the trial.

Non-small cell lung cancer NSCLC is a condition where cancer cells grow uncontrollably in the lung tissues. This study evaluates the safety of an investigational drug called telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses c-Met. The trial also monitors changes in disease activity and side effects over time. Participants will be randomly assigned to receive one of three different doses of telisotuzumab vedotin through intravenous IV infusion. Each dose group receives treatment as part of a study lasting up to three years. The study involves approximately 150 adults with c-Met positive NSCLC across many sites worldwide. Throughout the study, participants will attend regular hospital or clinic visits where they undergo medical assessments, blood tests, and complete questionnaires to evaluate how the drug affects their disease and any side effects experienced. The study measures treatment-related adverse events, disease response, and survival outcomes over the three-year period.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

This research aims to evaluate whether administering XEMBIFY every two weeks alongside Standard Medical Treatment SMT over a one-year period can reduce the number of major bacterial infections each year in adults with low antibody levels hypogammaglobulinemia who have B-cell Chronic Lymphocytic Leukemia CLL, Multiple Myeloma MM, or Non-Hodgkin Lymphoma NHL. The study compares this treatment to a placebo plus SMT to determine its impact on infection rates. Participants are randomly assigned to one of two groups. One group receives a loading dose of XEMBIFY subcutaneously at 150 mgkgday for five consecutive days starting in Week 1, followed by biweekly doses of 300 mgkg until Week 51. The other group receives a placebo injection on the same schedule. Both groups continue to receive the standard medical treatments and supportive care they require throughout the study. During the study, participants will have regular assessments including monitoring the frequency of infections, hospitalizations, and antibiotic use. Researchers will measure the annual rate of major bacterial infections and track the time to first infection among other outcomes up to Week 51. Participants are observed closely throughout the treatment year to evaluate safety and effectiveness, with the entire study lasting approximately one year per participant.