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Researchers are studying the effects of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for adults with Major Depressive Disorder MDD. This Phase III study aims to evaluate the safety, tolerability, and effectiveness of two different doses of CYB003 alongside participants current antidepressant medications and psychological support. Participants will be randomly assigned to one of three groups one receiving 8 mg of CYB003, another receiving 16 mg of CYB003, or a placebo group. Each participant will undergo two dosing sessions about three weeks apart while continuing their usual antidepressant treatment and receiving manualized psychological support from a facilitator. Non-responders in the placebo group may have the chance to receive CYB003 in an extension trial. During the study, participants will complete several assessments including the Montgomery-Asberg Depression Scale MADRS, Beck Depression Inventory-II BDI-II, Clinical Global Impression Scale CGI-S, Generalized Anxiety Disorder 7-Item Scale GAD-7, and Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q-SF. These evaluations occur at multiple timepoints from screening through the end of the trial. Safety and tolerability will be closely monitored throughout the study, with the total duration lasting approximately 12 weeks from baseline to study end.

Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 compared with placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded well to or cannot tolerate tumor necrosis factor TNF inhibitors andor Janus kinase JAK inhibitors. This Phase II, double-blind, placebo-controlled study aims to better understand how Afimkibart works for patients with this challenging form of RA. Participants in this study will receive Afimkibart or a matching placebo by subcutaneous injection. The study uses a randomized, parallel design with multiple groups receiving either Afimkibart or placebo. Dosing schedules and injection details are consistent across groups, with treatment effects assessed over a period including baseline, Week 14, and Week 24 timepoints. The study also includes monitoring of drug concentration and immune response markers up to Week 38. During the study, participants will be regularly assessed for changes in RA disease activity using scores such as DAS28-CRP and DAS28-ESR, joint counts, global assessments, pain levels, disability questionnaires, and inflammation markers. Safety is monitored through adverse event tracking and antibody testing. The total study duration includes treatment and follow-up periods lasting up to 38 weeks, allowing researchers to evaluate both short- and longer-term effects of the study drug.

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 program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are evaluating the medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.

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.