Sarajevo

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 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.

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.

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.

Researchers are evaluating SAR448501DR-0201 in adults with select autoimmune rheumatic diseases, including systemic lupus erythematosus SLE and rheumatoid arthritis RA. This open-label, phase 1 study aims to find optimal doses by studying safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial clinical responses. The study is sponsored by Sanofi and involves patients who meet specific disease activity and treatment history criteria. Participants will receive SAR448501 for up to 71 days, with multiple dose levels tested across different cohorts. Following treatment, a 42-week follow-up period will monitor participants, and if needed, visits will continue every 4 weeks until their blood B cells return to near-normal levels. This multi-ascending dose design allows careful observation of effects at increasing doses. Throughout the approximately 13-month participation, individuals will undergo screening, treatment, and extended follow-up. Assessments include monitoring adverse events, pharmacokinetic parameters, anti-drug antibodies, and clinical responses. Safety evaluations cover treatment-emergent adverse events and clinically significant abnormalities up to one year after treatment. Participants will have regular visits and blood tests to track progress and safety.

This observational study focuses on patients with nonvalvular atrial fibrillation who are receiving anticoagulant prophylaxis with apixaban. The research aims to evaluate the safety of apixaban by tracking the incidence of major bleeding and clinically relevant non-major bleeding, therapy adherence, and other adverse reactions excluding bleeding. The study is sponsored by Bosnalijek D.D and follows participants over six months to gather comprehensive safety and adherence data. 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 specific serum creatinine levels. The study involves four measurements over six months the first and last are in-person, while the middle two can be done by telephone if needed. Immediate reporting of any bleeding or serious adverse reactions is required through unscheduled visits. During the six-month follow-up, researchers will collect data on bleeding events, adverse reactions, and medication adherence using the BARS scale. Participants will undergo scheduled assessments at four time points, and any serious side effects will be promptly recorded. The primary outcome is the combined incidence of major and clinically relevant non-major bleeding. Secondary outcomes include adherence rates, overall bleeding events, and other adverse reactions 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.