Grants Pass

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

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 tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have a COPD diagnosis of at least one year, be receiving inhaled maintenance therapy, and have experienced at least two moderate or one severe COPD exacerbations in the past year. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand tezepelumab's impact on COPD symptoms and exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment phase will last for a minimum of 52 weeks and up to 76 weeks. After completing the treatment period, there will be a 12-week off-treatment safety follow-up to monitor participants' health. Throughout the study, participants will undergo regular assessments including lung function tests, questionnaires such as the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and blood tests to measure eosinophil counts and drug levels. Researchers will track the annualized rate of moderate or severe COPD exacerbations as the primary outcome. Other evaluations include monitoring exacerbations requiring emergency visits or hospitalization, lung function changes, symptom scores, and immune responses. Participant safety and adherence to the study protocol will be closely monitored during and after treatment.

Researchers are evaluating the efficacy and safety of tozorakimab, a drug administered under the skin, in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb study is designed as a double-blind, placebo-controlled trial to find the right dose range of tozorakimab for this group. The study aims to better understand how tozorakimab may impact asthma control and reduce severe asthma attacks in this population. Participants will be randomly assigned to one of three groups: one receiving a lower dose of tozorakimab, another receiving a higher dose or placebo, and a third group receiving placebo injections. All treatments are given by subcutaneous injection. The study will last for 26 to 52 weeks, during which the participants will be closely monitored for asthma exacerbations and lung function changes. This includes assessing how well tozorakimab is tolerated and how it affects asthma symptoms and quality of life. During the study, participants will undergo regular assessments including lung function tests, questionnaires about asthma control and quality of life, and blood tests to measure drug levels and immune response. Researchers will track the annual rate of severe asthma flare-ups as the main outcome. Safety will be monitored throughout the study period, and participants will be followed for up to one year. The study is designed to ensure participants receive careful observation and support while contributing valuable information about tozorakimab’s potential use in asthma treatment.

Researchers are evaluating the efficacy, safety, and tolerability of Suzetrigine (SUZ) in adults with pain caused by diabetic peripheral neuropathy (DPN). This Phase 3, randomized, double-blind study compares Suzetrigine to Pregabalin and placebo in participants diagnosed with type 1 or type 2 diabetes who experience bilateral lower limb pain associated with DPN. Participants will be randomly assigned to receive oral tablets of Suzetrigine, capsules of Pregabalin, or placebo matching either Suzetrigine or Pregabalin. The study includes a baseline period followed by 12 weeks of treatment, during which the effects on daily pain intensity and physical health status will be monitored and compared across groups. During participation, individuals will record daily pain levels using the Numeric Pain Rating Scale (NPRS) for baseline and weekly averages. Researchers will assess changes in pain intensity and physical function through patient reports up to week 12. Safety and tolerability will also be monitored throughout the study, which runs until May 2027.

Researchers are evaluating the long-term safety of rimegepant for the acute treatment of migraine in children and adolescents aged 6 to under 18 years. This study focuses on understanding how well rimegepant is tolerated and any side effects that may occur during extended use in this younger population with migraine, including those with or without aura. Participants will receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg as orally disintegrating tablets. This open-label study involves taking the medication as needed for migraine attacks over a period of up to 58 weeks, allowing researchers to observe safety and tolerability during regular use. Throughout the study, participants will be monitored for the frequency and severity of any adverse events, including serious side effects and those related to liver function. Blood samples will be collected, and migraine symptoms tracked to assess treatment impact. The study will last up to 58 weeks, with ongoing safety evaluations during this period to ensure careful observation of participant health.

Researchers are evaluating whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer (TNBC) who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.

Researchers are evaluating the safety and effectiveness of BHV-3000 (rimegepant) compared to a placebo for the acute treatment of moderate or severe migraine in children and adolescents aged 6 to under 18 years. This Phase 3 study focuses on those with a history of migraine lasting more than 6 months and experiencing 1 to 8 moderate or severe attacks per month. The goal is to measure relief from migraine pain and associated symptoms within hours after treatment. Participants receive either BHV-3000 (rimegepant) in doses of 75 mg or 50 mg orally disintegrating tablet (ODT) or a matching placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment. Participants may continue one stable preventive migraine medication but cannot use CGRP antagonists. The treatment is given during migraine attacks, and effects are compared between the groups. During the study, participants will be closely monitored with assessments of migraine pain relief, freedom from the most bothersome migraine symptoms, and the need for rescue medication within 24 to 48 hours after dosing. Functional ability and symptom freedom such as photophobia, phonophobia, and nausea are also evaluated. The study involves blood sampling and requires participants to weigh over 40 kg. The research team tracks safety, treatment response, and overall migraine control through questionnaires and clinical evaluations over the study period.

Researchers are evaluating the optimal duration of HER2-targeted therapy for patients with early-stage HER2-positive breast cancer who have achieved a complete response after preoperative chemotherapy with trastuzumab. This phase III trial compares 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade to see if shorter therapy is as effective and to assess quality of life differences. The study also aims to evaluate side effects, recurrence rates, overall survival, and patient-reported outcomes related to symptoms and quality of life up to 10 years post-treatment. Participants are randomly assigned to one of two groups. One group receives trastuzumab and possibly pertuzumab intravenously or subcutaneously every 21 days for up to 17 cycles (about 12 months), while the other group receives the same treatment for up to 9 cycles (about 6 months). Treatments are given unless disease progresses or unacceptable toxicity occurs. Throughout the trial, participants undergo heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, participants have regular assessments including quality of life questionnaires and monitoring for side effects. After treatment completion, follow-up visits occur every 6 months for 5 years or until cancer recurrence, then annually until 10 years from registration. Researchers measure recurrence-free survival, quality of life scores, adverse events, and survival outcomes. This long-term follow-up helps evaluate the lasting impact of shorter versus longer HER2-targeted therapy.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.