Merida

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 assessing the effectiveness and safety of current standard treatments in people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not adequately responded to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with active disease despite treatment, aiming to better understand outcomes in this group. Participants receive standard care treatments based on product labels, which include glucocorticoids and immunosuppressants, with at least one biologic therapy used for a minimum of three months. The study includes those with lupus nephritis confirmed by recent kidney biopsy showing specific active disease features. Treatment follows usual clinical practice without experimental therapies. During the study, participants will be monitored for disease remission using established lupus criteria at six months. Researchers will collect routine clinical data and track safety and response to treatments. The study requires participants to be at least 16 years old and to provide informed consent. Pregnant women and those involved in other experimental drug trials are excluded. The study involves ongoing clinical follow-up to evaluate outcomes over time.

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.

Researchers are evaluating the ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD5492 given by subcutaneous injection in adults with Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies (IIM), or Rheumatoid Arthritis (RA). This is an open-label, multi-center Phase I study designed to investigate these aspects in two parts: single ascending dose and step-up dose administration. The study aims to better understand how AZD5492 behaves and is tolerated in these patients. The study is divided into two parts. Part 1 involves a single ascending dose in adult participants with SLE, with plans to test up to five dose levels and possibly more based on emerging data. After a screening period of up to 42 days, participants receive one dose of AZD5492 and are followed for at least 179 days. Part 2 includes adult participants with SLE (who did not participate in Part 1), IIM, or RA, receiving two doses seven days apart in a step-up dosing design. The first dose is a priming dose, and the second is escalated with at least three target dose levels planned. The study duration is at least 180 days plus screening, with follow-ups possibly extending up to 12 months from study start. Participants attend visits at screening, multiple days within the first month, and at intervals up to day 180 or beyond depending on the part of the study. Safety is monitored by tracking treatment-emergent adverse events, dose limiting toxicities, serious adverse events leading to death, vital sign abnormalities, laboratory test changes, and ECG abnormalities. Researchers assess tolerability and safety throughout the study up to 52 weeks. Pharmacokinetic and pharmacodynamic measurements are also collected to evaluate the effects of AZD5492 in the participants.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.