Wyomissing

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are evaluating the efficacy and safety of HBS-301 in treating symptoms of idiopathic hypersomnia (IH), including excessive daytime sleepiness, sleep inertia, and fatigue. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 18 years and older diagnosed with IH. The study aims to compare HBS-301 to a placebo in relieving these symptoms and to assess its overall safety profile. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets during an 8-week double-blind treatment period. Before this, there is a screening and baseline period lasting up to 28 days. Following the double-blind phase, participants have the option to join a one-year open-label extension period where they may receive HBS-301. After completing treatment, a 30-day safety follow-up will monitor participants for any adverse effects. Throughout the study, participants will undergo various assessments including sleep studies and symptom evaluations to measure the effectiveness of HBS-301. Researchers will track changes in idiopathic hypersomnia symptoms from baseline through the end of the double-blind period. Safety will also be closely monitored during treatment and follow-up periods to ensure participant well-being over the course of the study, which may last over a year for those in the extension phase.

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.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of different doses of ELV001 in treating active rheumatoid arthritis (RA) in patients who have not responded well to methotrexate and tumor necrosis factor inhibitors. The trial plans to enroll around 180 to 220 adult participants aged 18 to 75 years with active RA meeting specific clinical criteria. The study aims to measure changes in disease activity using the DAS28-C-reactive protein score from baseline to week 12. The study includes four groups receiving placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. Participants receive treatment for 24 weeks, starting with a 4-week screening period. The first 12 weeks are double-blind and placebo-controlled, followed by a treatment extension from weeks 12 to 24 where some participants may have their ELV001 dose adjusted. After treatment, a 4-week safety follow-up period monitors participants for any adverse effects. Participants will have regular assessments including blood tests, joint evaluations, and monitoring of disease activity scores throughout the study. Researchers will track medication adherence and safety through physical exams, laboratory tests, and ECGs. The primary outcome focuses on improvement in disease activity at week 12. The total study duration for each participant is about 32 weeks from screening to the end-of-study visit.

This research aims to evaluate the effects of ALKS 2680 tablets on reducing daytime sleepiness, sudden muscle weakness (cataplexy), and symptoms in adults diagnosed with Narcolepsy Type 1 (NT1). The study is a Phase 3, randomized, double-blind, placebo-controlled trial involving participants aged 18 to 70 years who meet specific diagnostic criteria for NT1. Participants will be randomly assigned to receive either one of two dose levels of ALKS 2680 tablets or matching placebo tablets, taken orally once daily for 12 weeks. The study compares the impact of these treatments on symptom improvement and safety over this treatment period. Throughout the 12 weeks, researchers will assess changes in participants' ability to stay awake during the day using the Maintenance of Wakefulness Test (MWT), focusing on the mean sleep latency from the start to the end of treatment. Safety and symptom monitoring will be ongoing during the study to evaluate the medication's effects and tolerability.

Researchers are investigating the effects of ALKS 2680 tablets on adults diagnosed with Narcolepsy Type 2 (NT2). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how taking ALKS 2680 compares to a placebo in reducing daytime sleepiness and disease symptoms in this population. Participants will be assigned to receive one of three different daily doses of ALKS 2680 tablets or placebo tablets, taken orally for 12 weeks. The study evaluates the impact of these treatments on participants over this 12-week period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test (MWT) to measure changes in mean sleep latency from the start of the study to Week 12. Researchers will monitor adherence to lifestyle and treatment guidelines, including sleep-related therapies if applicable, and track safety and efficacy throughout the study duration.