Aventura

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are studying the safety and effects of VHB937 in people with early Alzheimers disease, including those with Mild Cognitive Impairment due to Alzheimers or mild Alzheimers itself. This randomized, double-blind, placebo-controlled Phase II trial aims to evaluate whether VHB937 can benefit memory, thinking abilities, daily functioning, and brain changes. The study also looks at how the body processes VHB937 and responds to it. Participants receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo, over a 72-week double-blind period. After this, an extension phase follows for further observation. The treatments are given through infusions, and participants are randomly assigned to one of the three groups in parallel. Throughout the study, participants and their study partners attend regular visits for assessments including clinical dementia rating scales, cognitive tests, daily living activities evaluation, and brain imaging biomarkers. Safety is monitored by tracking adverse events and serious adverse events. Blood samples are collected to measure VHB937 levels and immune responses. The total study duration includes the 72-week treatment period plus additional time in the extension phase.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are conducting a master protocol study to evaluate multiple pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

Researchers are evaluating the safety, side effects, and best dose of the drug SNDX-5613 combined with standard chemotherapy in patients newly diagnosed with acute myeloid leukemia AML that has specific genetic changes in the NPM1, MLLKMT2A, or NUP98 genes. This phase Ib trial focuses on patients aged 18 to 75 who are eligible for intensive induction therapy and aims to find the recommended dose for further studies while assessing the treatments effects on cancer cell behavior and response. Participants receive a combination treatment starting with induction therapy where SNDX-5613 is given orally twice daily from days 2 to 28, along with daunorubicin intravenously on days 1 to 3, and cytarabine by continuous infusion on days 1 to 7. Those who respond move on to consolidation treatment with cycles of SNDX-5613 and cytarabine every 42 days for up to three cycles. Patients with persistent disease may receive re-induction therapy. Various scans, blood tests, and bone marrow biopsies are done throughout these treatment phases to monitor progress and safety. During the study, participants undergo regular evaluations including heart scans echocardiogram or MUGA, bone marrow aspiration and biopsy before, during, and after treatment phases, and blood collections at specific times. Researchers measure recommended doses, treatment responses, drug levels in the body, and explore biomarkers related to treatment effectiveness and resistance. Follow-up continues for up to two years after treatment to observe long-term outcomes such as disease relapse or survival.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the long-term safety of buntanetap in people with Parkinsons Disease PD. This 36-month open-label study involves two groups one includes PD participants previously in buntanetap trials, and the other includes participants receiving deep brain stimulation DBS treatment. The study aims to monitor safety and adverse events related to buntanetap over an extended period. Qualified participants will take buntanetap capsules at a dose of 30 mg once daily after a screening period lasting up to 42 days. Cohort 1 includes those invited from prior buntanetap studies, while Cohort 2 consists of PD participants treated with DBS in specific brain areas for at least 12 months. Medication adjustments are required before visits to observe participants in an OFF medication state. Throughout the study, participants will have regular assessments conducted by trained clinicians using tools like MMSE, MoCA, C-SSRS, and MDS-UPDRS to evaluate cognitive and motor functions. Safety will be closely monitored, focusing on adverse events during the full 36 months. Support persons will accompany participants to visits, and medication stability and general health will be regularly evaluated to ensure study compliance and participant well-being.