Lorenskog

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

This research aims to evaluate HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one systemic anticancer therapy. The study includes participants with various cancers such as melanoma, head and neck squamous cell carcinoma, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The focus is to assess the treatments safety, tolerability, efficacy, and pharmacokinetics, along with exploring the relationship between HER3 protein expression and treatment response. Participants will receive intravenous infusions of HER3-DXd at a dose of 5.6 mgkg every three weeks Q3W. The trial is designed as a phase 2, multicenter, multicohort, open-label study involving a single treatment group receiving HER3-DXd monotherapy. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The study will also collect tumor tissue samples before treatment to analyze HER3 protein expression. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor response, safety evaluations, laboratory tests, and pharmacokinetic sampling at specified cycles. The primary outcomes include measuring objective response rates and, for prostate cancer participants, the proportion achieving significant decreases in PSA levels. Secondary outcomes cover treatment-emergent adverse events, duration of response, clinical benefit, disease control, progression-free survival, overall survival, and pharmacokinetic parameters. Participants will be followed for up to approximately 27 months to monitor these outcomes.

Researchers are evaluating the effects of ambroxol, a drug that enhances Glucocerebrosidase GCase, on cognition, functional decline, and neuropsychiatric symptoms in people diagnosed with prodromal and early dementia with Lewy bodies DLB. This phase IIa study aims to confirm how ambroxol influences these areas compared to a placebo, with attention to disease progression and biomarkers related to DLB. Participants will be randomly assigned to take either oral ambroxol or a matching placebo. The medication dose escalates over the first month, starting at 60 mg three times daily and increasing to 420 mg three times daily, continuing up to 550 days. The study includes a blinded phase lasting 18 months, followed by an open extension offering ambroxol to all participants for an additional year. Throughout the study, participants will attend eight hospital visits and receive sixteen telephone calls to monitor safety, side effects, and treatment adherence. Various assessments will be conducted, including cognitive tests, neuropsychiatric evaluations, blood tests, MRI, DaTSCAN imaging, ECG, EEG, and lumbar punctures. The primary outcomes focus on cognitive changes, global function, disease stage, and neuropsychiatric symptoms, with secondary and exploratory outcomes addressing sleep, motor symptoms, falls, and biomarker impacts.

Researchers are evaluating whether taking Atorvastatin 40mg daily can prevent chronic migraine episodes in adults aged 18 to 65. This study aims to confirm earlier findings from smaller trials about Atorvastatins beneficial effect and favorable side effect profile, while also exploring if a lower dose might be even better. Additionally, the study will estimate the overall cost of treatment, including medication, acute attack drugs, and lost work time. Participants are randomly assigned to one of two groups one group receives Atorvastatin 40mg once daily for 84 days, while the other takes a placebo daily for the same period. The study uses a triple-blind design to ensure unbiased results and compares these two parallel groups over the treatment period. During the study, participants will keep headache diaries to track migraine frequency. Researchers will measure the number of migraine days every four weeks, along with the number of responders, adverse events, use of acute medication, and days of sick leave over 12 weeks. Safety and effectiveness will be monitored throughout, with study visits scheduled accordingly. The total participation duration covers the treatment and follow-up periods until the study ends in 2029.

Researchers are evaluating the effects of Atorvastatin, a medication given daily at doses of 20mg or 40mg, for preventing episodic migraine in adults aged 18 to 65. This phase 2, randomized, triple-blind, multicenter study aims to confirm previous findings of Atorvastatins potential to reduce migraine frequency, explore the impact of a lower dose, assess its side effect profile, and estimate treatment costs including medication and work loss. Participants are assigned to one of three groups receiving either 40mg Atorvastatin, 20mg Atorvastatin, or a placebo once daily for 84 days. The study uses a parallel design to compare these treatments over the three-month period, with careful monitoring of migraine attacks and medication use. During the study, participants will keep a headache diary to record migraine frequency and medication use. Researchers will measure the number of migraine days every 4 weeks as the primary outcome, and secondary outcomes include responder rates, adverse events, use of acute migraine medication, and days of sick leave over 12 weeks. Monitoring includes regular assessments throughout the treatment period to evaluate effectiveness and safety.

This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist ICS-LABA. The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.

Researchers are evaluating a new treatment approach for adults with newly diagnosed Acute Myeloid Leukemia AML who have mutations in the NPM1 or KMT2A genes and are not eligible for intensive chemotherapy. The study focuses on adding revumenib, a drug that blocks a molecule called menin important for leukemia cell survival, to standard treatment with azacitidine and venetoclax. This is a randomized, double-blind, placebo-controlled Phase 3 clinical trial aiming to improve outcomes for these patients. Participants will receive either revumenib or a placebo alongside azacitidine and venetoclax in continuous 28-day treatment cycles. Treatment continues until disease progression, unacceptable side effects, death, withdrawal, or other protocol-defined reasons for stopping. After the last patient is enrolled, there will be a 4-year follow-up period to observe survival and ongoing health. During the study, patients will be closely monitored with regular assessments to track overall survival, rates and duration of remission, event-free survival, and quality of life. Genetic and molecular tests will evaluate response at the bone marrow and blood levels. Safety and tolerability will also be monitored throughout treatment and the follow-up phase, which together may last several years.

Researchers are evaluating the effects of nucresiran compared to a placebo in people with transthyretin amyloidosis with cardiomyopathy, a condition affecting the heart. This Phase 3 study aims to see if nucresiran can reduce death from any cause and cardiovascular events such as hospitalizations or urgent visits for heart failure. The study also looks at how the treatment impacts patients health status and quality of life. Participants are randomly assigned to receive either nucresiran 300 mg or a placebo, both administered by subcutaneous injection once every six months during the double-blind period. After this period, all participants receive nucresiran 300 mg every six months during an open-label extension. The double-blind period is expected to last about 32 months, with a maximum duration of up to 5 years. During the study, participants will have regular assessments to monitor outcomes like mortality, cardiovascular events, and patient-reported health measures using the Kansas City Cardiomyopathy Questionnaire. The primary outcome is a combined measure of all-cause mortality and recurrent cardiovascular events from the start of the study through the double-blind period. Safety and health status will be closely followed throughout the trial, which may continue until 2032.