Stockbridge

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 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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Graves' disease who continue to have hyperthyroidism despite treatment with antithyroid drugs (ATD). This Phase 2b randomized, double-blind, placebo-controlled study aims to compare IMVT-1402 with placebo by measuring thyroid hormone levels and ATD dose after 26 weeks. Participants will receive IMVT-1402 as a 600 mg injection under the skin once a week for either 52 weeks, or for 26 weeks followed by placebo injections for another 26 weeks. The placebo group will receive weekly placebo injections for 52 weeks. This design allows assessment of the drug's effects over time compared to placebo. During the study, participants will be monitored through laboratory tests measuring thyroid hormones (T3, FT4, TSH) to determine if they achieve normal thyroid function without ATD by Week 26. Safety and tolerability will also be evaluated throughout the treatment period. Participants must be adults between 18 and 75 years old and able to comply with study procedures.

Researchers are evaluating the optimal doses of E2086, an oral tablet, compared to a matching placebo in adults with narcolepsy to reduce excessive daytime sleepiness. This phase 2 randomized, double-blind, placebo-controlled trial focuses on measuring sleepiness using the Mean Sleep Latency (MSL) from four maintenance of wakefulness tests (MWTs). Participants include adults diagnosed with narcolepsy type 1 or type 2, with specific clinical and diagnostic criteria based on the 2023 International Classification of Sleep Disorders. Participants receive either E2086 or placebo tablets during the study. The treatment period lasts four weeks, during which participants complete the MWTs to assess changes in sleep latency. The study monitors the effect of the drug on daytime sleepiness compared to placebo and evaluates safety and tolerability. During the trial, participants will undergo assessments including sleep diaries, clinical history reviews, and MWTs at baseline and week 4. Researchers will measure changes in mean sleep latency to evaluate treatment effect. Safety monitoring includes tracking adverse events and clinical observations throughout the study. The total participation time includes screening, treatment, and follow-up assessments as required by the protocol.

Researchers are evaluating the safety and effectiveness of ALKS 2680 tablets in adults with Idiopathic Hypersomnia, a sleep disorder causing excessive daytime sleepiness. This Phase 2 study compares ALKS 2680 with placebo tablets to see if it can reduce daytime sleepiness. Participants will take oral tablets once daily, either ALKS 2680 or a placebo, during the study. The study is designed to find the appropriate dose level while monitoring safety and effectiveness. During up to 8 weeks of treatment, participants will be assessed for changes in daytime sleepiness using the Epworth Sleepiness Scale. Researchers will also monitor safety and participants' adherence to treatment and lifestyle requirements throughout the study.

Researchers are investigating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess changes in blood sugar control and dependence on prandial insulin over one year. The study follows established criteria for Stage 3 T1D diagnosis and includes participants on standard insulin therapy. Participants will receive either teplizumab or placebo through intravenous infusion. Both treatments are given as a solution for injection. The study spans approximately 84 weeks (18 months) for each participant, with the main treatment period lasting 52 weeks. The trial compares the effects of the two treatments on diabetes management and insulin use over this time. During the study, participants will undergo evaluations of their blood sugar control, including measurements of glycated hemoglobin (HbA1c) and insulin use. For those in European Union countries aged 5 years and older, additional tests will measure insulin production response after a meal. Safety and health will be monitored through regular clinical assessments, lab tests, and antibody screening. The study tracks changes from the beginning through the 52-week treatment period to understand the impact of teplizumab on diabetes progression.

This research aims to evaluate the safety and immune response triggered by mRNA-based vaccines targeting the influenza virus in healthy adults aged 18 years or older. It is a Phase 2, randomized, double-blind clinical study assessing both investigational and licensed flu vaccines to better understand their tolerability and ability to stimulate the body's defense against flu infection. Participants will receive a single dose of one of six investigational influenza vaccines or one of two licensed influenza vaccines as a comparison. The vaccine is administered as an injection in the arm. The study involves about 6 months of participation, including at least three visits to the study site where blood samples will be collected each time. A nasal swab will also be collected at the first visit. During the study, researchers will monitor local and systemic reactions within 7 days after vaccination, adverse events within 1 month, and serious adverse events as well as newly diagnosed chronic medical conditions within 6 months. The assessments include physical exams, medical history, and laboratory tests. This comprehensive monitoring aims to gather detailed safety and immune response data from all participants throughout their 6-month involvement.