Hendersonville

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are investigating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind trial focuses on adults aged 18 to 75 who have had gout for at least one year and experienced multiple gout flares in the past year. The study aims to assess the percentage of participants achieving an sUA level below 6.0 mg/dL at 24 weeks. Participants receive either dotinurad or allopurinol as oral over-encapsulated tablets. Allopurinol doses range from 200 mg/day for those with moderate kidney impairment to 600 mg/day, with participants maintaining a stable dose for at least three months before starting the study. The trial includes a 24-week treatment period where the effects of these medications on uric acid levels are monitored and compared. During the study, participants undergo regular assessments including serum uric acid measurements at screening and throughout the 24 weeks. Female participants of childbearing potential have pregnancy tests and must agree to contraception requirements. Researchers monitor safety, treatment adherence, and gout flare history to evaluate the treatments' efficacy and tolerability over the study period.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels at 24 weeks in adults with tophaceous gout. This condition involves the presence of measurable tophi, or deposits of uric acid crystals, in joints such as hands, wrists, feet, or ankles. The study is a Phase 3, randomized, double-blind, multicenter trial focused on adults aged 18 to 75 years who have had gout for at least one year. Participants receive either dotinurad or allopurinol in over-encapsulated tablet form, taken orally. The treatments are compared to see which better lowers sUA levels below 5.0 mg/dL after 24 weeks. The study includes a screening period before treatment begins, during which eligibility is confirmed, including measurements of tophi size and uric acid levels. During the study, participants will have regular assessments to monitor serum uric acid levels and the size of tophi. Safety and side effects will also be monitored throughout the 24-week treatment period. The main outcome is the percentage of participants who achieve sUA levels less than 5.0 mg/dL at week 24, helping to understand the comparative efficacy and safety of the two medications.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the effects and safety of the study medicine PF-07275315 for treating moderate to severe chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult and lowers quality of life. This clinical trial includes adults aged 35 to 80 years who have had COPD for at least 12 months and a history of at least two moderate or severe COPD flare-ups in the past year. The study has two phases: Phase 2 and Phase 3, each designed to assess different outcomes related to lung function and lung flare-ups over time. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections (shots under the skin) at the clinic. The Phase 2 part lasts 24 weeks with 11 clinic visits and focuses on the change in lung function measured by forced expiratory volume in 1 second (FEV1). The Phase 3 part lasts 52 weeks with 18 clinic visits and evaluates the annual rate of moderate or severe COPD flare-ups. Both study phases compare the effects of PF-07275315 to the placebo to assess safety and effectiveness. During the study, participants will visit the clinic regularly for assessments including lung function tests and health evaluations. They will continue their usual COPD maintenance treatments throughout the trial. Researchers will monitor lung function changes and the frequency of COPD exacerbations as primary outcome measures. Participants remain in the study for about 40 weeks in Phase 2 or about 68 weeks in Phase 3, including follow-up visits to ensure safety and collect health information.

Researchers are evaluating the safety and effects of a study medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. This condition makes breathing difficult and affects quality of life. The study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to determine if PF-07275315 is safe and effective for this group. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections administered in the clinic over 12 weeks. The study compares these two groups to assess treatment responses. The trial includes a total of 9 clinic visits and lasts about 7.5 months for each participant. During the study, participants will undergo various assessments including lung function tests to measure forced expiratory volume in 1 second (FEV1), safety monitoring through adverse event tracking, laboratory tests, vital sign checks, and electrocardiograms. These evaluations occur from baseline through 24 weeks to observe changes and treatment tolerability.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.