Miramar

Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.

Researchers are evaluating the safety and effectiveness of KT-621, an oral drug, in adults and adolescents aged 12 to 75 years with moderate-to-severe atopic dermatitis (AD), a common form of eczema. This phase 2b study aims to assess how well KT-621 reduces the severity and extent of AD, its safety and tolerability, how the drug behaves in the body, and the body's response to the drug. The study includes a 16-week double-blind, placebo-controlled period followed by a 52-week open-label phase. Participants will receive either KT-621 or a matching oral placebo during the initial 16-week double-blind period. Following this, all participants have the option to enter a 52-week open-label period where they receive KT-621. During these phases, participants will continue their regular use of moisturizers twice daily and adhere to the treatment plan. The study is conducted across multiple centers and includes dose-ranging to evaluate different doses of KT-621. Throughout the study, participants will have scheduled visits for assessments including clinical evaluations of eczema severity using the Eczema Area and Severity Index (EASI) score, which measures changes from baseline through week 16. Other evaluations include questionnaires, laboratory tests, and adherence monitoring via an electronic diary. Safety and tolerability are closely monitored, and participants are expected to comply with all study procedures over the entire duration of the trial, including both the double-blind and open-label periods.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Researchers are evaluating the safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are evaluating the effectiveness of the Erchonia EVRL laser device for home use to provide temporary relief from foot pain caused by idiopathic peripheral neuropathy. This study includes adults over 22 years old who have been diagnosed with idiopathic peripheral neuropathy and experience constant foot pain. The study uses a single active treatment group and aims to measure changes in pain levels using a visual analog scale over a 3-week period. Participants will self-administer the Erchonia EVRL laser treatment at home. The device uses red and violet laser diodes and is applied approximately 3 to 6 inches from the top of each foot. Treatments are done twice daily for 21 days, with each session lasting 5 minutes per foot, totaling 10 minutes per day. There is no placebo group; all participants receive the active laser treatment. During the study, participants will be monitored for changes in their foot pain ratings on the visual analog scale from baseline to three weeks. They must refrain from other foot pain therapies and maintain stable pain medication regimens. Assessments include self-reported pain levels, adherence to treatment, and safety monitoring throughout the trial, which lasts for the full 21-day treatment period.