Woodville South

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are studying the safety, tolerability, and best dosing of a drug called ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with a type of colorectal cancer called proficient mismatch repair pMMRnon-microsatellite instability-high non-MSI-H colorectal cancer. This study aims to find the highest safe dose of ABT-301 and the recommended dose for future studies while evaluating its effects in advanced or metastatic cases. Participants will take ABT-301 orally either once or twice daily in 21-day treatment cycles. Alongside ABT-301, participants will receive tislelizumab 200 mg and bevacizumab 7.5 mgkg via intravenous infusion on the first day of each 21-day cycle. The study has two parts a dose-escalation phase to identify safe dosing levels and a dose-optimization phase to further evaluate two selected doses for safety and activity against the cancer. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring safety and side effects, and pharmacokinetic and pharmacodynamic evaluations. These assessments occur from screening through treatment and up to 90 days after the last dose or until disease progression or death, lasting up to 28 months. The study monitors overall survival, progression-free survival, and duration of response to treatment.

Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.

Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis MF. The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.

Researchers are evaluating the safety and effectiveness of new treatments and combinations in adults with metastatic colorectal cancer CRC. This Phase II, global, open-label study includes a master protocol with substudies to test these treatments in participants who have not received prior systemic therapy for advanced disease and whose cancer is mismatch-repair-proficient pMMR or microsatellite stable MSS without liver metastases. Participants will be randomly assigned to one of two groups one receiving volrustomig combined with FOLFIRI a chemotherapy regimen of irinotecan, fluorouracil, and leucovorin plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab alone. All treatments are given as intravenous infusions. The study aims to compare these combinations over approximately three years. During the trial, participants will undergo regular assessments including tumor measurements, safety monitoring through adverse event tracking, and laboratory tests. Researchers will evaluate progression-free survival, overall survival, response rates, and drug concentrations in the body. The study includes monitoring for immune responses and other side effects, with total participation lasting up to about three years.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Metastatic colorectal cancer mCRC is a common type of cancer, especially in developed countries. This trial evaluates the safety and changes in disease activity when an investigational drug, telisotuzumab adizutecan, is given with standard chemotherapy regimens including oxaliplatin, fluorouracil 5FU, leucovorin LV, and targeted therapies bevacizumab or panitumumab. Researchers aim to determine tolerable and effective doses and compare these treatments in adult participants with mCRC. The study is divided into two stages. The first stage involves dose escalation where participants receive increasing intravenous doses of telisotuzumab adizutecan combined with either FOLFOX fluorouracil, leucovorin, oxaliplatin plus bevacizumab or 5FULV plus panitumumab until a tolerable and potentially effective dose is identified. In the second stage, participants are randomized into three groups to receive either one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FULV and panitumumab, or a comparator group receiving FOLFOX with bevacizumab or panitumumab. The study lasts about six years. Participants will attend regular visits at approved hospitals or clinics throughout the study. Researchers will monitor treatment effects through medical assessments, blood tests, symptom questionnaires, and tracking of side effects. Key outcomes include tumor response, adverse events, progression-free survival, duration of response, overall survival, and disease control. This comprehensive monitoring aims to evaluate both safety and effectiveness of the treatment combinations over the study period.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.