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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 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.

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 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.

Grade I ankle sprains are common injuries, especially among athletes, women, teenagers, and those who are physically active. These sprains can lead to long-term problems like chronic ankle instability or osteoarthritis. Treatment typically involves conservative methods, such as the PRICEMMS protocol, which includes protection, rest, ice, compression, elevation, modalities, medication, and support. Surgery is generally reserved for more severe cases. Although the Bowen technique has been effective for other musculoskeletal problems, it has not been widely studied for Grade I ankle sprains. The study evaluates treatments including cryotherapy, therapeutic exercises, use of braces, and the Bowen technique to assess their effects on Grade I ankle sprains. Participants receive these therapies as part of their rehabilitation to support recovery and manage symptoms. Participants will be monitored to assess pain intensity subjectively after 3 weeks of treatment. The study focuses on evaluating how these treatments impact pain and recovery from the ankle sprain. Researchers will track progress and symptoms during this period to understand the effectiveness of the approaches used.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.

Researchers are evaluating the effectiveness and safety of namodenoson in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 cirrhosis whose disease has worsened after at least one prior treatment. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial compares namodenoson to placebo in this patient group. The study focuses on overall survival up to 60 months following randomization. Participants will be randomly assigned in a 2:1 ratio to receive either namodenoson 25 mg or a matching placebo, taken orally twice daily in continuous 28-day cycles. Treatment will continue until disease progression or unacceptable side effects occur. After stopping treatment, patients will have a follow-up visit 28 days later. Those who consent will be followed long-term for survival, including those who discontinue dosing. After the trial's blind is broken, surviving patients still on the study drug may be offered continued open-label namodenoson treatment. During the study, participants will have regular safety assessments and tumor imaging every two cycles to monitor disease status. Researchers will collect survival data and monitor any adverse effects throughout the trial and follow-up periods. The total participation time may extend up to 60 months or longer depending on survival and ongoing follow-up.

Researchers are evaluating the pharmacokinetic profile of naldemedine and its active metabolite nor-naldemedine after a single oral dose in pediatric patients who are receiving or about to receive opioid treatment. The study focuses on children aged 2 to 18 years with opioid-induced constipation or at risk of developing constipation. This Phase 1/2 open-label study aims to assess how the drug behaves in the body, including its absorption, metabolism, and clearance. Participants receive naldemedine either as an oral tablet (0.2 mg dose) or as an oral suspension at various dose levels. The study involves monitoring drug levels in the blood at specific time points after dosing, including several samples on Day 1, a sample before the Day 2 dose, and additional sampling on Day 7 for some participants. These measures help evaluate the drug's maximum concentration, time to reach maximum concentration, total exposure over time, elimination rate, half-life, clearance, and volume of distribution. During the study, participants will remain in the clinic for blood sampling for at least 12 hours after the first dose and return for a 24-hour post-dose sample. Researchers will measure detailed pharmacokinetic parameters to understand the drug's safety, tolerability, and behavior in the pediatric population receiving opioids. The study includes careful monitoring of participants' health and response during the study period, with a focus on children with cancer or non-cancer pain treated with opioids.

The trial investigates the safety and effectiveness of a medication called OCTAPLEX, a four-factor prothrombin complex concentrate, in patients experiencing acute major bleeding while on direct oral anticoagulant (DOAC) therapy with a factor Xa inhibitor. This phase 3, multicenter, prospective, randomized, double-blinded study compares two doses of OCTAPLEX, low-dose and high-dose, to assess hemostatic efficacy in this patient group. Participants will be randomly assigned in a 1:1 ratio to receive either the low-dose or high-dose OCTAPLEX. The study focuses on patients who have acute major bleeding related to their use of oral factor Xa inhibitors. Treatment administration and the comparison of dosing strategies are designed to evaluate how well OCTAPLEX controls bleeding in these patients. During the study, researchers monitor the effectiveness of the treatment by measuring hemostatic efficacy within 24 hours after starting management. Patients are closely observed for safety and treatment response. The duration of participation involves initial treatment and monitoring of bleeding control, with assessments based on clinical signs and laboratory tests related to bleeding and clotting function.