Murrieta

Researchers are evaluating the use of PET imaging with the radioligand 18FPI-2620 to detect tau protein deposits in people with Alzheimers disease and healthy controls. This open-label, multi-center, non-randomized Phase 3 study aims to compare PET imaging results during life with brain tissue analysis after death to better understand tau pathology in Alzheimers. The study is sponsored by Lantheus Biosciences Ltd. and focuses on diagnostic accuracy and safety of this imaging technique. Participants receive an intravenous injection of 18FPI-2620 at a dose of 185 MBq 20%. The study involves a PET scan procedure that participants must tolerate, including lying still in the scanner. There are no randomized groups or placebo controls as this is an open-label study. The research compares the PET imaging findings with post-mortem brain autopsy results to evaluate the ability of this imaging to detect tau deposits accurately. During the study, participants undergo PET imaging and are monitored for their ability to tolerate the scan. Brain donation consent is required for post-mortem histopathological comparison. Researchers assess the diagnostic performance of the PET scan in correctly identifying tau-related pathology and Alzheimers disease changes. The primary outcome focuses on the accuracy of visual assessment of PET images compared to autopsy findings, with follow-up continuing until study completion and an average of one year after death.

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease DED who have a specific TNFR1 genotype. This study is a phase 2b3, double-masked, randomized, vehicle-controlled trial aimed at understanding how licaminlimab affects symptoms of dry eye in this particular group. Participants first undergo a run-in period using artificial tear drops three times daily for about 14 days. Following this, they are randomly assigned to receive either licaminlimab eye drops or a placebo vehicle, both administered three times daily for 29 days. The study compares these two treatments to assess their impact on dry eye discomfort. During the study, participants eye discomfort severity is measured at the start and after 29 days of treatment, focusing especially on those with the specific genotype. Additional assessments include overall symptom changes regardless of genotype. The study tracks safety and effectiveness over this period, with the total participation lasting approximately 43 days including the run-in and treatment phases.

This research aims to evaluate the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis UC. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study that includes participants aged 16 to 80 years. The study is sponsored by Sanofi and focuses on assessing clinical remission and other important health outcomes in UC. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week Pivotal Maintenance Sub-Study followed by a 240-week Open-Label Extension OLE Sub-Study for those who continue. Those not entering the OLE will have a 45-day follow-up after the maintenance period. There are up to 32 on-site visits in total, with 21 visits during the maintenance phase and 11 during the extension. During the study, participants will have clinical assessments including endoscopy to evaluate remission and mucosal healing, symptom tracking such as bowel urgency and abdominal pain, and quality of life questionnaires. Safety is monitored through adverse event reporting and blood tests for drug concentrations and antibodies. The primary outcome is the proportion of participants achieving clinical remission by the modified Mayo Score at Week 40, with follow-up continuing up to 286 weeks for some participants.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating NEU-411 in adults aged 40 to 80 years who have early Parkinsons Disease PD with elevated activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 study aims to assess the safety and effectiveness of NEU-411, a selective brain-penetrant inhibitor of LRRK2, compared to placebo in participants with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411 at 30 mg once daily or a matching placebo for a 52-week treatment period. After this phase, participants may join an open-label extension to receive NEU-411 treatment for an additional 26 weeks. The study evaluates treatment effects on PD symptoms and adverse events. During the study, participants will undergo assessments including the Roche digital biomarker score using a Parkinsons Disease application and the Movement Disorder Societys Unified Parkinsons Disease Rating Scale. Safety monitoring includes tracking treatment-emergent and serious adverse events, with a follow-up visit scheduled within two weeks after treatment ends. Total study participation may extend up to 78 weeks including the extension phase.

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been treated with systemic therapy before. The study compares the anti-tumor effects of amivantamab combined with pembrolizumab and carboplatin against pembrolizumab with 5-fluorouracil and platinum therapy carboplatin or cisplatin. Participants have HNSCC in the oral cavity, oropharynx, hypopharynx, or larynx but not nasopharynx or unknown primary tumor sites, and HPV status is considered for oropharynx cases. Participants are randomly assigned to one of two groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other receives pembrolizumab, 5-fluorouracil given as a 4-day infusion, and carboplatin or cisplatin. Treatments are given according to standard protocols for these drugs. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored for overall survival and tumor response using established criteria up to about 3 years and 7 months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires specific to head and neck cancer, and safety evaluations through adverse event and lab test monitoring. Blood samples will check amivantamab levels and antibodies. Participation involves regular visits for treatment and assessments throughout the study period.

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for women with acute uncomplicated urinary tract infections UTI caused by drug-resistant E. coli. The study aims to find the best dosing regimen and compare the treatments safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprimsulfamethoxazole TMPSMX. Eligible participants must have an active acute UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts. Part 1 is an open-label dose regimen selection with 30 patients divided into three groups receiving different doses of LBP-EC01 via intraurethral and intravenous administration alongside oral TMPSMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMPSMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMPSMX and specified LBP-EC01 doses on days 1 to 3. Participants will provide urine, blood, and stool samples for microbiological and pharmacokinetic analyses. Researchers will monitor clinical symptoms, microbiologic responses, adverse events, and immunogenicity over several follow-up visits up to six months. The main outcomes include drug levels in urine and blood, symptom resolution, and microbiological cure by day 10. Safety and tolerability are also closely observed throughout the study.

Researchers are evaluating STM-416, a drug studied for safety and tolerability in patients with recurrent high-grade papillary non-muscle-invasive bladder cancer NMIBC without carcinoma in situ CIS. This first-in-human, Phase 12a, multi-center study includes patients who have completed standard of care SOC and have visible recurrent disease, focusing on those undergoing transurethral resection of bladder tumor TURBT without perioperative intravesical chemotherapy. The study aims to determine the safety of STM-416 administered during surgery and to explore its effects alongside SOC therapy given afterward. The study has two parts. Phase 1 is an open-label, dose-escalation phase where up to six increasing doses of STM-416 are given intraoperatively in 3 to 6 patients per dose to assess safety and tolerability. Phase 2a is a randomized, single-blind, dose-expansion phase comparing two doses of STM-416 administered during TURBT followed by SOC therapy. All participants receive SOC treatment after surgery. The study plans to enroll about 30 patients in Phase 1, with additional participants in Phase 2a. Participants will undergo TURBT surgery with STM-416 treatment during the procedure, followed by SOC therapy. Researchers will monitor dose-limiting toxicities and adverse events for up to 90 days in Phase 1 and track recurrence-free survival for up to 24 months in Phase 2a. Pharmacokinetics and pharmacodynamics of STM-416 will be studied at various time points after administration. Overall, participants will be followed regularly to assess safety, treatment response, and disease recurrence as part of the study lasting up to two years.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.