Banja Luka

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the pharmacokinetics, safety, and tolerability of aumolertinib in European participants diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR). This Phase 1, open-label, multicenter study focuses on patients with confirmed activating EGFR mutations, including ex19del, L858R, or T790M. The study targets those whose cancer is not suitable for curative surgery or definitive radiotherapy and who meet specific treatment history and health status requirements. Participants receive oral aumolertinib at a dose of 110 mg once daily during 21-day treatment cycles. In Part A, pharmacokinetic (PK) assessments are conducted on specified days within the first two cycles to measure drug and metabolite levels at various time points. In Part B, participants may continue the treatment beyond Cycle 2 until disease progression, intolerable toxicity, or other discontinuation criteria. Safety assessments and tumor evaluations take place according to clinical indications throughout the study. During the study, participants visit the site multiple times for PK sampling and safety checks, including laboratory tests and imaging scans to evaluate tumor response. The end of treatment visit occurs within 7 days after stopping the study drug, followed by a safety follow-up visit approximately 28 days later. The main outcomes measured are pharmacokinetic parameters such as Tmax, Cmax, AUC0-24h, and Cmin of aumolertinib and its metabolites on specific days of treatment cycles.

Researchers are evaluating the safety, tolerability, early clinical effects, pharmacokinetics, and pharmacodynamics of azenosertib (also known as ZN-c3) combined with chemotherapy or bevacizumab in women with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label, multicenter study includes patients with platinum-resistant or advanced disease and explores two parts: combination with chemotherapy and combination with bevacizumab as maintenance therapy after platinum-based chemotherapy. The study has two parts. Part 1, which is completed, tested azenosertib with chemotherapy drugs including pegylated liposomal doxorubicin, carboplatin, paclitaxel, or gemcitabine in patients with platinum-resistant cancer. Part 2 is ongoing and involves dose escalation and expansion phases to assess azenosertib combined with bevacizumab as first- or second-line maintenance treatment. Dose escalation identifies the recommended dose, while dose expansion evaluates this dose in patients who responded to prior platinum therapy and progressed on a PARP inhibitor. Participants will be monitored for safety and tolerability throughout the study, which can last about one year. Researchers will measure maximum tolerated dose, pharmacokinetics, and clinical responses, including disease control. Evaluations include medical assessments, laboratory tests, and monitoring of adverse effects. The study aims to find safe dosing and gather preliminary activity data to support further research.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

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.

Researchers are evaluating whether giving XEMBIFY® every two weeks along with Standard Medical Treatment (SMT) over one year can reduce the rate of serious bacterial infections in adults with low antibody levels (hypogammaglobulinemia) who have B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. This phase 3 clinical trial compares XEMBIFY® plus SMT to a placebo plus SMT to see which better prevents infections in this group. Participants receive either XEMBIFY® or placebo through a subcutaneous infusion pump every two weeks, combined with their regular medical treatments. The study is randomized, double-blinded, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment during the trial. Throughout the study, researchers will monitor participants for infection rates, specifically tracking major bacterial infections over about 51 weeks. Participants will have regular assessments including safety monitoring, pharmacokinetics, and infection tracking. The total study duration for each participant includes one year of treatment and observation, with careful follow-up to evaluate the treatment’s impact and safety.

Researchers are studying participants with Relapsing Multiple Sclerosis (RMS) to compare how the body processes ublituximab when given as a subcutaneous (under the skin) injection versus an intravenous (IV) infusion. This Phase 3, open-label, parallel-group, multicenter study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological, and clinical effects of these two methods of administering ublituximab. The purpose is to understand if the subcutaneous form is not inferior to the intravenous form. Participants will receive ublituximab either by IV infusion or subcutaneous injection. The study includes ongoing treatment and monitoring to assess how the drug behaves in the body and its effects. The comparison focuses on the area under the curve (AUC) of ublituximab concentration from the start of treatment through 24 weeks. During the study, participants will undergo assessments including clinical evaluations and radiological tests to monitor disease status and treatment effects. Safety and pharmacodynamic measures will be recorded throughout the study. The total treatment and observation period includes at least 24 weeks of follow-up to evaluate the drug's profile and impact on participants with RMS.

Researchers are evaluating the use of a score-based decision-making algorithm to guide the duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The study aims to compare this algorithm-guided approach to the standard care DAPT duration without risk score guidance. This randomized trial is designed to assess if the algorithm can better balance bleeding and ischemic risks and improve patient outcomes. Participants will be randomly assigned to either an algorithm-guided DAPT group or a standard-of-care DAPT group. The algorithm group will have DAPT duration tailored based on the PRECISE-DAPT score, PCI complexity, and clinical presentation (acute or chronic coronary syndromes). Treatment varies from 1 to 12 months of aspirin combined with a P2Y12 inhibitor, followed by monotherapy. The standard care group will receive DAPT duration according to the operator's discretion following current guidelines. During the study, participant health will be monitored for one year to measure net adverse clinical events, including death, heart attacks, strokes, stent thrombosis, and significant bleeding. Data collection will be embedded within an existing PCI registry to support a cost-effective and pragmatic trial design. The study involves informed consent, follow-ups, and assessments to evaluate safety and efficacy over the one-year period.

This research aims to evaluate whether the drug CYB704, a proposed biosimilar to Ocrevus, works similarly to the original Ocrevus treatment in adults with relapsing multiple sclerosis (RMS). The study focuses on comparing how CYB704 is distributed in the body, its treatment effects, and side effects to those of Ocrevus. It is a Phase 3 clinical trial that seeks to demonstrate pharmacokinetic similarity and assess efficacy, safety, pharmacodynamics, and immunogenicity. Participants will receive either CYB704 or Ocrevus (from the US or EU) through intravenous infusions. The study is randomized, double-blind, and parallel-group in design. Participants will undergo at least 15 treatment visits involving drug administration and clinical checkups. Regular magnetic resonance imaging (MRI) scans will be performed to monitor disease activity and treatment effects. Throughout the study, participants will have various assessments including neurological evaluations and safety monitoring. The primary outcome measure focuses on the area under the concentration-time curve during weeks 1 to 3 and weeks 3 to 25 to assess drug pharmacokinetics. The total involvement includes treatment visits, MRI scans, and clinical tests to provide comprehensive data on the effects and safety of the treatments over time.

Researchers are comparing two treatments for patients experiencing ST-elevation myocardial infarction (STEMI), a serious heart attack type. The study evaluates the use of a drug-coated balloon (DCB) versus the standard drug-eluting stent (DES) during percutaneous coronary intervention (PCI), which is a procedure to open blocked arteries. This is a randomized, multicenter trial where patients are assigned to either treatment after meeting specific angiographic criteria following lesion preparation. In the experimental group, patients receive a paclitaxel-coated balloon delivering 3.0-3.5 µg/mm² after successful preparation of the blocked artery, ensuring less than 30% residual narrowing and good blood flow. If the balloon treatment is not satisfactory, a drug-eluting stent may be implanted as a backup. The control group receives a second-generation drug-eluting stent using standard techniques based on current guidelines. Randomization occurs after confirming eligibility and lesion preparation success. Participants will be monitored for outcomes including the device-oriented composite endpoint (DoCE) at one and two years. The study involves assessments of the treated artery’s condition, safety, and effectiveness of the interventions. Follow-up will include clinical evaluations and tracking of any major cardiac events to compare the two treatment approaches over time.