Dickson

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 volixibat's 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 solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

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 ifetroban's 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 palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with ER-positive, HER2-negative advanced breast cancer who have not received prior systemic anti-cancer treatment for their advanced disease. This international, phase 3 trial aims to assess the efficacy and safety of these drug combinations as first-line treatments for this type of breast cancer. The study includes both women and men and is sponsored by Olema Pharmaceuticals, Inc. Participants are randomly assigned in a double-blind manner to one of two groups: one receives palazestrant 90 mg once daily plus ribociclib 600 mg daily for 21 days in a 28-day cycle with a placebo matching letrozole, while the other receives letrozole 2.5 mg once daily plus ribociclib 600 mg daily for 21 days with a placebo matching palazestrant. Treatment cycles repeat every 28 days, continuing as per study protocol. During the trial, participants will be monitored with assessments including progression-free survival, overall survival, tumor response rates, duration of response, and clinical benefit rate, with evaluations lasting up to 3.5 years. Safety, drug levels, and patient-reported health outcomes will also be regularly collected every 28 days. The study involves approximately 1,000 participants and includes ongoing safety monitoring up to 42 days after treatment ends, with follow-up for survival and response outcomes extending up to 5.5 years.

Researchers are evaluating the effectiveness and safety of Adagrasib (MRTX849) alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups: two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments' impact and tolerability throughout the study period.

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. The study aims to assess the safety of PF-08634404 when given alone or in combination with other anticancer drugs and to observe how this cancer responds to these treatments. Participants must be adults with locally advanced or metastatic RCC who have not received prior treatment for their advanced kidney cancer. Participants will be randomly assigned to one of three groups: receiving PF-08634404 alone through intravenous (IV) infusion, PF-08634404 combined with ipilimumab, or PF-08634404 combined with axitinib. All treatments are administered by IV infusions at clinical study sites, where medical staff will monitor participants during and after each visit. The study includes phases 1b and 2 to evaluate safety and efficacy over time. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and adverse events, and evaluating survival and progression-free survival for up to approximately three years. Laboratory tests, pharmacokinetics, and immunogenicity will also be tracked. The study will continue monitoring participants for safety up to 90 days after the last treatment dose, with the total participation duration lasting about three years.

Researchers are evaluating the combination of the investigational drug mevrometostat (PF-06821497) with enzalutamide compared to enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study aims to determine if the combination improves outcomes in participants who have only received limited prior therapy such as androgen-deprivation therapy or first-generation antiandrogens. Participants will be randomly assigned to one of two groups: one group will receive mevrometostat (875 mg twice daily) combined with enzalutamide (160 mg once daily), while the other group will receive a placebo twice daily plus enzalutamide (160 mg once daily). The study includes a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. The treatment phase may last up to approximately 4 years, with ongoing safety and long-term assessment extending beyond this period. During the study, participants will be monitored through various evaluations including scans, blood tests, and patient-reported questionnaires assessing pain and quality of life. Researchers will measure outcomes such as radiographic progression-free survival, overall survival, prostate-specific antigen response, and adverse events, among others. Follow-up will continue for several years to assess long-term effects and disease progression, ensuring comprehensive safety and efficacy data collection throughout the trial.

Researchers are conducting a multicenter, randomized, open-label phase 3 trial to evaluate treatments for patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors (ICI). The study focuses on patients positive for the HLA-A2 phenotype with either squamous or non-squamous histology. The trial compares the cancer vaccine OSE2101 to the standard chemotherapy drug docetaxel. Stratification factors include cancer histology and the patients' performance status. Participants will be randomly assigned in a 2:1 ratio to receive either OSE2101 or docetaxel. OSE2101 is a peptidic cancer vaccine given by subcutaneous injection every three weeks for six cycles, then every eight weeks through the first year, and every twelve weeks during the second year. Docetaxel is given as an intravenous infusion every three weeks. Additionally, a companion diagnostic device system is used to detect HLA-A2 status and analyze genetic markers. During the study, patient survival will be monitored from the time of randomization for an average of three years. Researchers will track overall survival as the primary outcome. Patients will undergo regular treatment visits, assessments, and monitoring according to the schedule. Safety, efficacy, and disease progression will be evaluated throughout the trial period, which starts in December 2024 and continues until December 2028.