Banja Luka

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating the pharmacokinetics PK, safety, and tolerability of aumolertinib in European adults diagnosed with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific activating mutations in the EGFR gene. This Phase 1, open-label, multicenter study focuses on participants whose tumors have mutations such as ex19del, L858R, or T790M. The goal is to better understand how aumolertinib and its metabolites behave in the body and their safety profile in this population. Participants receive aumolertinib orally at a dose of 110 mg once daily under fasting conditions in 21-day treatment cycles. The study has two parts Part A involves detailed PK assessments with visits for blood sampling on specific days within the first two treatment cycles to analyze drug levels. Part B allows participants to continue aumolertinib treatment beyond Cycle 2 until disease progression, intolerable side effects, or other discontinuation reasons determined by the investigator. During the study, participants will undergo safety evaluations and tumor assessments according to clinical needs. Blood samples for PK analysis are collected at multiple time points during the early treatment cycles. After stopping treatment, participants will have an End of Treatment visit within 7 days and a safety follow-up visit approximately 28 days after the last dose. The primary outcomes include measuring drug concentration peaks and exposure over 24 hours, while secondary outcomes focus on adverse events throughout the study, which may last about 18 months on average.

Researchers are evaluating the safety, tolerability, early clinical effects, and how the body processes azenosertib ZN-c3 when combined with other drugs in patients with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label study includes patients with platinum-resistant or maintenance therapy contexts, aiming to understand dosing and treatment combinations better. The study has two parts Part 1 assessed azenosertib with chemotherapy drugs including carboplatin, pegylated liposomal doxorubicin PLD, paclitaxel, and gemcitabine in platinum-resistant cases. Part 2 explores azenosertib with bevacizumab as first- or second-line maintenance therapy after platinum chemotherapy. Dose escalation and expansion phases determine recommended doses and evaluate safety. Participants will receive study treatments in combination regimens and undergo regular assessments over about one year. Researchers monitor safety, side effects, and drug levels, aiming to find the maximum tolerated dose and recommended dosing. The study includes clinical evaluations, laboratory tests, and ongoing monitoring of patient response and tolerability throughout the study period.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

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.

Researchers are investigating the use of aspirin combined with a P2Y12 inhibitor, known as dual antiplatelet therapy DAPT, which is the standard treatment for patients undergoing percutaneous coronary intervention PCI with stent placement. The trial aims to compare a score-based decision-making method for determining DAPT duration against the usual care approach that does not use such risk scores. This study is a randomized, single-blind trial designed to provide direct evidence on whether using risk scores improves patient outcomes. The study will include 2788 patients aged 18 years and older who have undergone PCI with stent implantation. Participants will be randomly assigned to one of two groups an algorithm-guided DAPT duration group where therapy length is decided based on the PRECISE-DAPT score, PCI complexity, and clinical condition, or a standard-of-care group where treatment duration is left to the operators discretion. The algorithm group uses specific treatment plans based on risk scores and clinical presentation, with therapy lasting from 1 month up to 12 months followed by monotherapy. Participants will be monitored over one year to assess various outcomes including death, myocardial infarction, stroke, stent thrombosis, and bleeding events. The main measure is a composite of net adverse clinical events NACE occurring within one year. The study will also track adherence to therapy and other cardiovascular events. Safety and effectiveness will be evaluated to understand if the algorithm-guided approach better balances bleeding and ischemic risks compared to standard care.

Researchers are evaluating the use of drug-coated balloons DCB compared to drug-eluting stents DES in percutaneous coronary intervention PCI for patients experiencing ST-elevation myocardial infarction STEMI. The study aims to compare these two treatments following successful preparation of the blocked artery and confirmation that all entry criteria are met. This randomized controlled trial is conducted internationally and sponsored by the Institute of Cardiovascular Diseases, Vojvodina. Patients will be randomly assigned to receive either a paclitaxel-coated balloon delivering 3.0-3.5 micrograms per square millimeter or a second-generation drug-eluting stent. The DCB group may receive a stent as a backup if the balloon treatment result is unsatisfactory. Standard implantation techniques will be used for the DES group. Randomization occurs after confirming the artery is suitable for treatment. Participants will be followed for up to two years to assess a device-oriented composite endpoint DoCE and other outcomes including bleeding complications, target vessel revascularization, and vessel failure. Evaluations will occur at one year and two years after treatment. The study does not use blinding, and participants will be monitored for safety and treatment effectiveness during this period.

Researchers are evaluating the efficacy and safety of Imeroprubart in adults with active Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a condition affecting the peripheral nerves. This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study aims to understand how well Imeroprubart works compared to placebo in treating CIDP. The study is sponsored by Immunovant Sciences GmbH and focuses specifically on adults meeting diagnostic criteria for typical or variant forms of CIDP. Participants will receive either Imeroprubart or a matching placebo by subcutaneous injection once weekly. The treatment period includes an initial 24-week phase Period 1 with Imeroprubart or placebo, followed by an extension to 52 weeks Period 2 for continued evaluation. Imeroprubart dosing is given once weekly via subcutaneous injection. Placebo is provided similarly during the first 24 weeks. During the study, participants will be monitored through clinical assessments including relapse status by Week 24, as well as measurements of disability, grip strength, muscle strength, and symptom scores. Electrodiagnostic tests support diagnosis at baseline. Safety and efficacy will be closely observed during treatment, with follow-up visits scheduled to assess outcomes. The total participation duration covers at least 24 weeks for the primary outcome assessment, with ongoing monitoring as defined by the study protocol.

Researchers are studying advanced hepatocellular carcinoma HCC in patients who have Child-Pugh Class B7 cirrhosis and whose cancer has worsened after at least one prior treatment. This clinical trial aims to compare the safety and effectiveness of the drug namodenoson with a placebo in this group of patients. The trial is a Phase 3, multicenter, randomized, double-blind study designed to provide clear evidence on the benefits and risks of namodenoson for this condition. Participants will be randomly assigned to receive either namodenoson 25 mg or a matching placebo by mouth twice daily in 28-day cycles. Treatment continues until the disease progresses or side effects become unacceptable. Tumor imaging is performed every two cycles to monitor disease status. After stopping the study drug, patients will have a follow-up visit 28 days later, and those who agree will be monitored long-term for survival. If results allow, some patients may continue taking namodenoson openly beyond the blinded phase. During the study, participants will regularly visit the clinic for safety checks, laboratory tests, and tumor imaging. The main outcome measured is overall survival up to 60 months after randomization. Secondary outcomes include progression-free survival, objective response rate, and the nature of side effects. Pharmacokinetics of namodenoson will also be studied. Long-term survival data will be collected for those who consent to follow-up, ensuring thorough monitoring throughout the study period.