Colorado Springs

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.

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are studying patients who have cancer or may be at risk of developing cancer to improve the standard of care. This observational study collects blood, tissue, and other biological samples along with associated data such as surveys, medical records, and cancer registry information. The goal is to enable new clinical trials, technology advancements, and personalized medicine for cancer patients over time. Participants provide consent to allow collection and storage of their biological samples and data. This includes blood and tissue samples as well as survey assessments and medical chart reviews. The study does not involve treatment but focuses on gathering information to support cancer research and care improvements. During the study, patients biological samples and data are collected and stored long-term. Researchers analyze survey responses, medical records, and biological specimens to measure outcomes related to improving cancer care standards. The study follows participants for up to 20 years, aiming for a lifetime partnership to support ongoing cancer research and care advancements.

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

This research aims to evaluate the safety and effectiveness of duvakitug injection in people with moderately to severely active Crohns Disease. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study focused on maintaining treatment benefits. The study includes participants aged 16 to 80 years and is sponsored by Sanofi. Participants receive subcutaneous injections of duvakitug or placebo according to the study protocol. The trial includes a 40-week pivotal maintenance sub-study followed by a 240-week open-label extension sub-study for those who continue. The total treatment duration may be up to 280 weeks, with up to 43 on-site visits throughout the study. During the study, participants will have regular assessments including clinical remission, endoscopic response, and other measures related to Crohns Disease activity. Safety is monitored by tracking adverse events and antidrug antibody levels. There is a 45-day follow-up visit after treatment ends. The study duration may be up to 286 weeks depending on participation in the extension phase.

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 the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.