Woodville South

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating the maximum tolerated dose and safety of Anvumetostat, a PRMT5 inhibitor, given in combination with other therapies for adults with metastatic or locally advanced gastrointestinal, biliary tract, or pancreatic cancers that have a specific genetic deletion called homozygous MTAP-deletion. This phase 1b study aims to find the recommended dose while monitoring safety and tolerability in these patients. Participants will receive Anvumetostat orally along with other treatments including gemcitabine and nab-paclitaxel given intravenously, modified FOLFIRINOX (a combination of irinotecan, 5-FU, leucovorin, and oxaliplatin given IV), or RMC-6236 taken orally. The study includes different subprotocols for patients based on their cancer characteristics and previous treatments. Treatment schedules and combinations are carefully evaluated to determine the best dosing. During the study, participants will be closely monitored for side effects such as dose limiting toxicities, treatment emergent adverse events, and serious adverse events for up to about two years. Researchers will assess organ function, tumor response using RECIST criteria, and overall safety. The study involves tumor biopsies or archival tissue samples and various clinical assessments throughout the treatment and follow-up periods to ensure comprehensive evaluation of the drug combinations.

This research aims to evaluate the safety and tolerability of increasing doses of ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with proficient mismatch repair (pMMR)/non-microsatellite instability-high (non-MSI-H) colorectal cancer. The trial seeks to determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) of ABT-301. The study includes patients with advanced or metastatic colorectal cancer who have undergone at least two prior systemic therapies. Participants receive ABT-301 orally once or twice daily in 21-day treatment cycles. Tislelizumab 200 mg and bevacizumab 7.5 mg/kg are administered by intravenous infusion on Day 1 of each cycle every three weeks. The study has two parts: Part 1 involves dose escalation to find the MTD and RP2D, while Part 2 evaluates two selected ABT-301 dosing regimens for safety, tolerability, and antitumor activity. Throughout the study, participants undergo regular assessments including imaging and laboratory tests to monitor tumor response, safety, and tolerability. The primary outcomes include safety, MTD determination, and efficacy measures such as progression-free survival. Participants are followed from screening to 90 days after the last dose in Part 1 and up to 28 months in Part 2, with ongoing monitoring of disease progression or survival.

Researchers are evaluating the safety, tolerance, and effects of elritercept, alone and combined with the JAK inhibitor ruxolitinib, in adults with myelofibrosis (MF). This Phase 2 study aims to learn how elritercept impacts the signs and symptoms of MF, how the body processes the drug, and its effects on anemia and blood cell counts. Elritercept is an investigational protein designed to boost red blood cell and platelet production by blocking certain signals that suppress blood formation. Participants receive elritercept as a subcutaneous injection either alone or in combination with oral ruxolitinib tablets. The study includes different groups based on prior treatments: those previously treated with JAK inhibitors and those currently on ruxolitinib with insufficient disease control or side effects limiting dose. A specific group in Brazil includes participants with no prior JAK inhibitor treatment. The study monitors participants over about 8 years, including long-term extension periods. During the study, participants will be regularly assessed for side effects, blood cell levels, and overall health. Researchers will track adverse events and serious side effects from informed consent through 30 days after the last dose. Other evaluations include laboratory tests, symptom assessments, and pharmacokinetic analyses to understand how elritercept behaves in the body. Participants agree to follow all study procedures and return for follow-up visits throughout the study period.

Researchers are evaluating the safety and effectiveness of new treatment combinations for participants with metastatic colorectal cancer (mCRC). This Phase II global study uses a master protocol with substudies focused on participants who have mismatch-repair-proficient (pMMR) or microsatellite stable (MSS) mCRC without liver metastases and who have not previously received systemic treatment for advanced disease. Participants will be randomly assigned to one of two treatment groups: one receiving Volrustomig combined with FOLFIRI (a regimen of irinotecan, fluorouracil, and leucovorin) plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab only. All medications will be given as intravenous infusions. This modular study takes place across multiple centers worldwide. During the approximately three-year participation, researchers will measure progression-free survival and monitor adverse events. Participants will undergo regular evaluations including tumor assessments by RECIST 1.1 criteria and organ function tests. Safety and treatment effects will be closely observed throughout the study period to understand the impact of these new treatment combinations.

Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib (TAK-279) works in adults with active PsA, considering their prior treatment experiences with specific medications. The study is a Phase 3 trial that compares zasocitinib to a placebo in participants who have or have not been treated with biologic medicines. Participants will receive either zasocitinib tablets or a matching placebo. The study is randomized, double-blind, and placebo-controlled. Treatment will continue with monitoring over a period of up to 60 weeks to assess the effects and safety of zasocitinib. During the study, participants will undergo assessments of joint and skin symptoms, including tender and swollen joint counts and evaluations of psoriatic skin lesions. Researchers will measure how many participants achieve a significant improvement in their arthritis symptoms by Week 16. Safety and response will be monitored throughout the study period, with detailed follow-up visits and evaluations to understand the treatment's impact over time.

Researchers are evaluating the effectiveness and safety of standard chemotherapy alone or combined with INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma (PDAC) with a KRAS G12D mutation. This phase 3, randomized, double-blind study focuses on individuals who have not received prior treatment for metastatic PDAC. The goal is to understand if adding INCB161734 to chemotherapy improves outcomes in this group of patients. Participants will receive either oral INCB161734 tablets or a placebo, along with a chemotherapy regimen selected by the investigator following specific protocol requirements. The chemotherapy options are defined by the study protocol. Treatments will be administered as planned during the study period, with careful monitoring to assess their effects. Throughout the study, participants will be monitored for overall survival up to approximately three years, progression-free survival, and objective tumor response assessed up to about two years. Researchers will conduct regular evaluations including clinical assessments and imaging reviewed by blinded independent central review (BICR). Safety and efficacy data will be collected to understand the impact of the treatments over time.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate 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 experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are evaluating AMG 410, alone and in combination with other agents, in adults with advanced or metastatic solid tumors that have KRAS gene alterations. This Phase 1/1b study aims to assess the safety, tolerability, how the drug is processed and acts in the body, and preliminary effectiveness of AMG 410. The study seeks to find the highest dose of AMG 410 that can be given safely or the recommended dose for further studies in this population. The study starts with a dose-escalation phase where participants receive oral AMG 410 either by itself or with other drugs, including intravenous pembrolizumab or panitumumab. Dose levels increase based on a model to identify the maximum tolerated dose or recommended Phase 2 dose. Following this, expansion groups may enroll participants at selected doses to better understand safety, drug behavior, and early signs of tumor response. Treatment continues until disease worsens, unacceptable side effects occur, or other stopping criteria are met, for up to three years. Participants will undergo evaluations including monitoring for side effects such as dose limiting toxicities, treatment emergent adverse events, and serious adverse events up to about three years. Tumor response will be assessed using standard criteria, and participants must provide recent tumor tissue samples or undergo biopsy. Regular assessments of organ function and overall health will be done. The study involves close follow-up to determine safety and early effectiveness of AMG 410 in this patient group.