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Researchers are studying Major Depressive Disorder MDD to evaluate the effectiveness, safety, and tolerability of a drug called CYB003 compared to a placebo. This Phase III trial involves adults with moderate to severe depression who have not responded well to current antidepressant treatments. The study is sponsored by Cybin IRL Limited and aims to understand how well CYB003 works as an additional treatment alongside existing antidepressants. Participants will be divided into three groups. One group will receive 8 mg of CYB003 in two dosing sessions about three weeks apart, another group will receive 16 mg of CYB003 on the same schedule, and a third group will receive a placebo during the two sessions. All participants will continue their current antidepressant medication and receive psychological support throughout the study. Non-responders to placebo may be eligible for an extension trial to receive CYB003. During the trial, participants will be evaluated using several scales that measure depression severity, anxiety, global impression of illness, and quality of life at various points before, during, and after treatment. These assessments include the Montgomery-Asberg Depression Scale MADRS, Beck Depression Inventory, and others. The study will monitor participants for safety and treatment effects over about 12 weeks, including follow-up visits at the end of the trial.

Researchers are evaluating the drug brenipatide compared to a placebo in adults with Alcohol Use Disorder AUD and hazardous alcohol use. The study aims to assess the drugs effect on drinking patterns and its safety. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and will last about 56 weeks. Participants receive escalating doses of brenipatide or placebo, administered as subcutaneous injections. The study includes a multi-period design with two experimental periods for brenipatide dosing and a placebo group. Participants or trained support persons will perform self-injections, and the study medication is blinded to ensure unbiased results. Throughout the trial, participants will attend regular visits for assessments including drinking behavior using the Timeline Followback Method, alcohol craving scales, health questionnaires, and body weight measurements. Blood samples will be taken to analyze drug levels and immune response. Participants will keep diaries and complete questionnaires to monitor adherence and effects. Safety and tolerability will be closely monitored during the 56-week participation period.

Researchers are studying Afimkibart RO7790121 to assess its effectiveness and safety compared with a placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded to or cannot tolerate tumor necrosis factor TNF andor Janus kinase JAK inhibitors. This phase II, multicenter, double-blind, placebo-controlled trial is sponsored by Hoffmann-La Roche. The study aims to evaluate changes in disease activity and various health assessments related to RA. Participants will be randomly assigned to receive either Afimkibart or a matching placebo through subcutaneous injections. There are two experimental groups receiving Afimkibart and one placebo group. The study will monitor participants over several weeks, assessing treatment effects at weeks 14 and 24, with safety follow-up up to week 38. During the study, participants will undergo assessments including joint counts, disease activity scores like DAS28-CRP and DAS28-ESR, physical and patient global assessments, health questionnaires, and laboratory tests for inflammation markers. Researchers will also monitor for adverse events and measure drug levels and antibodies. The total participation includes multiple visits over about 38 weeks to carefully evaluate treatment impact and safety.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating a medicine called BI 3000202 in adults with moderate to severe systemic lupus erythematosus SLE. This study aims to find out if different doses of BI 3000202 help people with SLE and to determine the best dose. The trial is a randomized, placebo-controlled, double-blind Phase II study sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of five groups four groups receive different doses of BI 3000202, and one group receives a placebo tablet that looks identical but contains no medicine. All participants continue their usual SLE treatment while taking the study tablets daily for one year. The study includes regular visits and health checks during this period. During the study, participants visit the study site regularly for health assessments and monitoring of any side effects. Doctors compare the results between groups, focusing on the Systemic Lupus Erythematosus Responder Index SRI-4 response at Week 32 as the primary outcome. The total participation lasts slightly longer than one year to ensure thorough evaluation of treatment effects and safety.

Researchers are evaluating how the study medicine PF-06823859 dazukibart works in adults with idiopathic inflammatory myopathies, specifically dermatomyositis DM and polymyositis PM. These conditions cause muscle inflammation leading to weakness and may include a skin rash in DM. The study aims to assess the safety and effects of dazukibart compared to a placebo in people receiving stable doses of corticosteroids or immunosuppressants. Participants will receive either the study medicine or a placebo through an intravenous infusion lasting about one hour. These infusions occur every four weeks from Day 1 through Week 48 at the study site. The study is randomized and double-blind, meaning neither participants nor researchers know who gets the medicine or placebo during the trial. Participants will be involved for about 13 months, attending 15 visits at the study site. During these visits, muscle strength, skin condition, physical function, fatigue, itch, and corticosteroid use are assessed. The main measurement is the Total Improvement Score at 24 or 52 weeks depending on location. Safety and other symptom measures will be monitored throughout the study period.

This research aims to evaluate three new tests designed to measure frailty more easily in patients awaiting surgery for bowel cancer. Frailty is common in older patients, especially those over 75, and is linked to higher risks of complications and death after surgery. The study seeks to improve how frailty is identified before surgery to support better counseling and potential treatments that could enhance patient fitness and safety. All participants will complete baseline assessments including functional, frailty, nutritional, and quality of life questionnaires, along with a blood test. A subgroup of 30 participants, split evenly between frail and non-frail patients, will wear a digital motion device for seven days before surgery. Assessments are scheduled to coincide with routine clinic visits, and participants opting for the device will receive instructions on its use. Participants will be involved in various evaluations such as blood tests, questionnaires, and the use of a digital motion device for some. Researchers will monitor frailty levels, mortality, adverse events, and quality of life after surgery at specific intervals. The study will also track survival rates at 3 months and 5 years. The total participation timeline extends until December 2029, with ongoing data collection to better understand frailtys impact on surgical outcomes.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.