Sarajevo

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 the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

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 evaluating SAR448501/DR-0201, a bispecific antibody, in adult patients with specific autoimmune rheumatic diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This phase 1, open-label study aims to find optimal dose(s) by assessing safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical response. The study involves adults aged 18 to 75 years who meet specific disease activity and treatment history criteria. Participants receive multiple ascending doses of SAR448501 during a 71-day treatment period. The study includes a screening period of up to 28 days before treatment and a 42-week follow-up period after treatment. If needed, participants continue visits every 4 weeks after the study ends until their peripheral blood B cells return to at least 80% of the lower limit of normal or their baseline level. Throughout the study, participants undergo assessments for treatment-emergent adverse events and clinically significant abnormalities from baseline to week 52. Researchers monitor safety and activity through clinical evaluations, including disease activity scores and laboratory tests. The total participation time is approximately 13 months, covering screening, treatment, and follow-up phases.

This research focuses on patients with nonvalvular atrial fibrillation to evaluate the safety and adherence to anticoagulant prophylaxis using apixaban. The study aims to determine the rates of major and clinically relevant non-major bleeding, adherence to therapy, and the frequency and types of other adverse reactions during treatment. Participants will be observed over six months with four scheduled assessments. Participants will take apixaban orally, with a standard dose of 5 mg twice daily or a reduced dose of 2.5 mg twice daily for those aged 80 or older, weighing 60 kg or less, or with elevated serum creatinine levels. The study includes both in-person and telephone visits, with unscheduled check-ins if serious bleeding or adverse reactions occur. During the study, participants will be assessed for bleeding events and other adverse reactions at each visit. Adherence to medication will be measured using the BARS scale. The primary outcome includes the incidence of major bleeding and clinically relevant non-major bleeding from enrollment until the end of the six-month period. Safety and therapy adherence will be closely monitored throughout.

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.