Dickson

Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.

Researchers are evaluating the investigational drug volixibat for treating itching pruritus caused by Primary Biliary Cholangitis PBC, a liver disease. This Phase 2 clinical trial aims to learn more about volixibats effects on itching and its potential impact on PBC disease progression. The study is sponsored by Mirum Pharmaceuticals, Inc. Participants are randomly assigned to one of several groups receiving either volixibat capsules at doses of 20mg or 80mg twice daily, or placebo capsules without the active drug, also taken twice daily. The trial includes two parts, with some participants receiving volixibat 20mg twice daily and others receiving matching placebo capsules. The study is double-blind, meaning neither participants nor researchers know which treatment is given. During the study, participants itching levels are monitored using the Adult Itch Reported Outcome questionnaire over 28 weeks. Researchers also assess quality of life, fatigue, sleep disturbance, liver function tests, bile acid levels, and adverse events. Participants will attend regular visits for assessments, and the main outcome measured is the change in daily itch scores from baseline to week 28. The study excludes healthy volunteers and focuses on adults aged 18 years and older with confirmed PBC.

Researchers are evaluating the safety and effectiveness of oral ifetroban in patients with idiopathic pulmonary fibrosis IPF, a condition that causes lung scarring from various causes such as genetics, radiation, or bleomycin treatment. This phase II, multicenter, randomized, placebo-controlled study compares ifetroban to a placebo in adults aged 40 years and older who have confirmed IPF. The study aims to assess ifetrobans ability to prevent and treat lung fibrosis over a 12-month period. Participants will be randomly assigned to receive either 250 mg of oral ifetroban or a matching placebo capsule once daily for 12 months. Patients may continue stable background therapy with antifibrotic agents if applicable. The study includes two groups one receiving ifetroban and the other receiving placebo, with treatments administered daily. Blood and urine samples will be collected to measure both standard and novel biomarkers related to progressive pulmonary fibrosis. Throughout the study, participants will undergo safety and efficacy assessments including lung function tests, quality of life questionnaires, and monitoring for adverse events. Researchers will measure changes in forced vital capacity FVC over 12 months as the primary outcome. Secondary outcomes include time to acute exacerbations, hospitalizations, death, and symptom changes such as dyspnea, cough, and fatigue. Participants health will be regularly monitored via clinical evaluations and laboratory tests to ensure safety and track treatment effects.

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with advanced breast cancer that is estrogen receptor positive ER and human epidermal growth factor receptor 2 negative HER2-. This phase 3 clinical trial includes women and men who have not yet received systemic treatment for their advanced breast cancer, aiming to find improved first-line treatment options. Participants are randomly assigned to one of two groups one group receives palazestrant 90 mg daily with ribociclib 600 mg daily taken on days 1-21 of each 28-day cycle plus a placebo matching letrozole the other group receives letrozole 2.5 mg daily with ribociclib 600 mg daily plus a placebo matching palazestrant. Treatments are given in repeating 28-day cycles. The study is double-blind and active-controlled, meaning neither participants nor researchers know who receives which treatment, and both groups receive active drugs. During the trial, participants will be monitored regularly for disease progression and survival over approximately 3.5 to 5.5 years. Assessments include tumor response evaluations, safety and tolerability checks, pharmacokinetic blood tests every 28 days, and patient-reported health outcomes. The primary outcome is progression-free survival, measuring the time from randomization until disease worsens or death. Safety monitoring continues for up to 42 days after treatment ends, with the study lasting until 2032.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating a new medicine called PF-08634404 for adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study aims to assess the safety, effectiveness, how the medicine moves through the body, and its impact on cancer-related markers. This is a Phase 1B2 treatment study sponsored by Pfizer. Participants are divided into two groups Cohort A includes those who have already received treatment and will receive PF-08634404 alone, while Cohort B includes untreated participants who will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both study medicines are given through an intravenous infusion. Treatment continues as long as it is beneficial and side effects are manageable. Before starting treatment, participants undergo a screening period to confirm eligibility. During the study, they have regular visits for treatment, health assessments, and tests to monitor cancer response, including scans. If the cancer worsens but treatment still helps and side effects are manageable, participants may continue treatment with approval. The study tracks outcomes such as tumor response, adverse events, survival, and drug levels over up to three years.

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma RCC, a type of kidney cancer that has spread locally or to other parts of the body. This study aims to understand how the medicine works alone or combined with other anticancer treatments, focusing on safety and cancer response. Participants must be adults with advanced RCC who have not yet received treatment for their advanced kidney cancer. Participants will receive PF-08634404 through intravenous infusions either alone or combined with other anticancer medicines such as ipilimumab or axitinib. The study includes different groups receiving these treatments sequentially, with all infusions delivered at clinical sites by medical staff. Treatment and evaluation will continue for up to approximately three years. During the trial, participants will have regular assessments including scans and lab tests to monitor cancer response and safety. Researchers will measure outcomes such as the confirmed objective response rate, adverse events, dose-limiting toxicities, and survival. Pharmacokinetics and immune responses to the study drug will also be tracked. Participants may be followed for up to three years to evaluate treatment effects and safety.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.

Researchers are evaluating the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.