Tarnow

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are investigating the effects of two different doses of Glycopyrronium (GP) metered dose inhaler (MDI) compared to a placebo MDI when added to background treatment with Budesonide and Formoterol Fumarate (BFF) MDI. This study focuses on children aged 4 to less than 12 years who have asthma. The goal is to assess how these treatments affect lung function in this pediatric population during a Phase II clinical trial. The study is designed as a multi-center, randomized, double-blind, 3-period, 6-sequence crossover trial. It begins with a 3-week run-in period, followed by three separate 3-week treatment periods during which participants receive one of the three treatments: BFF MDI plus GP MDI Dose A, BFF MDI plus GP MDI Dose B, or BFF MDI plus placebo MDI. All inhalers are taken twice daily via oral inhalation. After completing the treatment periods, participants attend a safety follow-up visit 12 to 16 days after their last dose. Participants will undergo regular assessments including lung function tests to measure Forced Expiratory Volume in one second (FEV1) one hour after dosing at the end of treatment. Researchers will monitor safety through clinical exams and follow-up visits. The total participation duration includes the run-in, treatment periods, and safety follow-up, providing a comprehensive evaluation of the treatments' effects on asthma control in children.

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 studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.