Douglas

Researchers are studying the prevalence, risk factors, and effects of chronic post-surgical pain in children aged 0 to 16 years undergoing common pediatric surgeries such as laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair, and circumcision. The study aims to understand how factors like parent and child anxiety, existing pain, and acute post-operative care relate to the development of chronic pain over time. This knowledge will help improve care and reduce the risk of long-term pain in children after surgery. The study involves completing questionnaires at six different times, starting before surgery, then at Day 2, 3-4 weeks, 3-4 months, and finally 10-12 months post-surgery. These questionnaires assess pain levels, function, and related factors. The study is conducted across multiple international centers and focuses on both elective and emergency surgeries. Participants will be involved in providing information through these questionnaires over about one year. Researchers will measure outcomes like the presence of chronic pain 10-12 months after surgery. The study will also monitor the impact of chronic pain on children's quality of life, emotional well-being, and social functioning. Families unable to complete follow-up surveys or those with language barriers may not participate, ensuring accurate and complete data collection.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

Researchers are evaluating the safety and tolerance of elritercept, a recombinant fusion protein, in adults with anemia linked to lower-risk myelodysplastic syndromes (MDS). The study aims to understand how elritercept affects red blood cell production and to monitor participants for any worsening of MDS during treatment. This is a Phase 2, open-label study focused on patients with very low, low, or intermediate risk MDS. Participants receive elritercept through subcutaneous injections at different dose levels to assess safety and effects. The study includes multiple parts, with initial treatment cycles followed by an extension phase for those who complete the first part without dose-limiting toxicities and may benefit from continued treatment. The study also includes several cohorts based on specific MDS characteristics and transfusion needs. During the study, participants undergo regular evaluations including blood tests, bone marrow assessments, and monitoring for adverse events. Researchers will track the number of treatment-emergent and serious adverse events for up to 11.2 years. Participants are closely monitored for how well they tolerate elritercept and its impact on anemia and red blood cell production throughout the study duration.

Researchers are evaluating how well elritercept (TAK-226, KER-050) works in reducing the need for red blood cell (RBC) transfusions in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require regular blood transfusions. The study is a Phase 3, double-blind, randomized, placebo-controlled trial that also aims to assess the safety and tolerability of elritercept over both short and longer periods, including in adults with high transfusion needs. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept or a matching placebo by subcutaneous injection every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue the same treatment. Following these phases, an Extension Phase allows eligible participants to continue treatment until discontinuation or study unblinding. Study visits occur every 2 weeks during the first 6 cycles and every 4 weeks thereafter. Treatment continuation depends on meeting disease assessment criteria every 24 weeks. Participants will undergo various assessments including bone marrow aspirates, transfusion evaluations, and disease status checks throughout the study. Safety follow-up lasts for 8 weeks after the last dose, with visits every 4 weeks during this time. Afterward, long-term follow-up occurs quarterly for up to 5 years or until withdrawal, death, loss to follow-up, or study closure. The main outcome measured is the percentage of participants achieving transfusion independence for at least 8 weeks during the first 24 weeks of treatment.

Researchers are evaluating a combination treatment using tagraxofusp, venetoclax, and azacitidine in adults with previously untreated CD123-positive acute myeloid leukemia (AML) who cannot receive intensive chemotherapy. This Phase II study is divided into two parts: Part 1 determines the appropriate dose of tagraxofusp to use with venetoclax and azacitidine, and Part 2 further evaluates this dose in two groups based on TP53 mutation status. The study focuses on participants who are either older or have other health conditions making intensive chemotherapy unsuitable. The treatments include tagraxofusp given by intravenous infusion for three consecutive days in each 28-day cycle, oral venetoclax tablets daily with a dose ramp-up during the first cycle, and azacitidine administered either under the skin or by intravenous infusion over seven days each cycle. Part 1 tests two doses of tagraxofusp (9 and 12 micrograms per kilogram per day) combined with the other drugs, while Part 2 uses the dose selected from Part 1 in the two participant groups. Participants will be monitored during up to four treatment cycles, each lasting 28 days, with assessments to determine the best overall response, such as complete remission. The study evaluates safety and effectiveness and includes regular visits for treatment administration, health checks, and laboratory tests. The entire treatment evaluation period lasts up to 112 days, during which researchers will track outcomes and side effects.

This research aims to evaluate the efficacy and safety of telitacicept in treating generalized myasthenia gravis (gMG), an autoimmune disease where autoantibodies disrupt nerve-to-muscle communication, causing muscle weakness that worsens with activity. The study addresses the challenge of limited effective therapies for this condition. Telitacicept is a fully human fusion protein designed to block specific immune system signals that promote B-cell growth and maturation, potentially reducing autoimmune symptoms in gMG. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension. Participants will receive subcutaneous injections of either telitacicept or placebo. The study includes a 4-week screening period, a 24-week double-blind treatment phase, a 48-week open-label extension, followed by a variable-duration extended open-label extension until telitacicept is approved or development ends, and an 8-week end-of-study follow-up. Participants will undergo assessments including the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score to measure changes in daily functioning by Week 24. The study also monitors safety and efficacy over the treatment and extension periods. Throughout the trial, various clinical evaluations will be conducted to track disease status and response to treatment, ensuring comprehensive monitoring of participant health and outcomes.

Researchers are evaluating the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

This research aims to evaluate the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). It is a Phase 2/3, randomized, open-label, multisite study including participants aged 18 and older. The study tests two main hypotheses: that ZV combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is better than R-GemOx alone for progression-free survival; and that ZV combined with bendamustine rituximab (BR) is better than BR alone. However, enrollment in the BR and ZV + BR arms is discontinued, so no outcome analysis will be done for those groups. The study is split into two parts: Part 1 confirms the dose of ZV, and Part 2 expands to evaluate its efficacy. Participants receive intravenous infusions of ZV at various doses, along with standard drugs including rituximab, gemcitabine, oxaliplatin, and bendamustine as appropriate. Prophylactic granulocyte colony-stimulating factor (G-CSF) is given with each ZV cycle according to institutional guidelines. Treatment schedules and doses are carefully managed to assess safety and treatment effects. During the study, participants will be monitored for dose-limiting toxicities up to about 6 weeks, and adverse events for up to approximately 68 months. Researchers will also track treatment discontinuations due to adverse events. Key outcomes include overall survival and progression-free survival up to about 35 months. Participants will have regular assessments including scans, clinical evaluations, and laboratory tests to measure response and monitor safety throughout their participation.

Researchers are conducting a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate the effectiveness, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. The study focuses on participants aged 18 to 75 years who have this diagnosis and are still experiencing hyperthyroidism. Participants will receive either IMVT-1402 or a placebo for 26 weeks. The study includes two dosing regimens of IMVT-1402: Dose 1 administered for 26 weeks and Dose 2 also administered for 26 weeks. The placebo group will receive treatment for the same duration. The treatments are given as drugs, and the study is designed to keep both participants and researchers unaware of which treatment is assigned. During the study, researchers will monitor participants to see how many achieve normal thyroid function (euthyroid) and remain off antithyroid drugs by Week 26. Participants will be assessed regularly to evaluate safety, tolerability, and treatment effects. The involvement includes following the assigned treatment and attending scheduled visits for evaluations. The total participation time corresponds with the 26-week treatment period.