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Researchers are evaluating the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analog, as an additional treatment for adults with Major Depressive Disorder (MDD). This Phase III, multi-center, double-blind, randomized controlled study compares two active doses of CYB003 against a placebo in patients experiencing moderate to severe depression who have not adequately responded to stable antidepressant treatment. Participants will receive either one of two doses of CYB003 or a placebo, along with manualized psychological support provided by a facilitator. The study includes a screening period, a dosing period, and follow-up assessments. The psychological support sessions are standardized to assist participants during the trial. During the study, participants will be assessed using the Montgomery-Asberg Depression Scale (MADRS) at multiple time points including screening, baseline, and several days during treatment up to the trial's end at Day 84. Researchers will monitor symptoms of depression, safety, and tolerability throughout the trial. Participants will also undergo various evaluations to ensure adherence and safety during the study period, which spans approximately 12 weeks from screening through the final assessment.

Researchers are evaluating the efficacy and safety of Afimkibart (also known as RO7790121) compared with a placebo in adults with moderate to severe rheumatoid arthritis (RA) who have not responded adequately or cannot tolerate tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors. This Phase II, multicenter, double-blind, placebo-controlled study focuses on participants who have active RA with specific joint swelling and tenderness, and who meet established RA classification criteria. Participants will receive either Afimkibart or placebo administered as a subcutaneous injection. The treatments are given to compare how well Afimkibart works against the placebo in reducing disease activity in RA patients with an inadequate response or intolerance to prior treatments. The study carefully monitors responses over a fixed timeline, including evaluations at baseline and Week 14. During the study, participants will undergo assessments measuring changes in the Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) from baseline to Week 14. Researchers will monitor safety and efficacy through physical exams, laboratory tests, and other clinical evaluations. The study excludes individuals with certain prior treatments or medical conditions to ensure participant safety and reliable results.

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating whether different doses of the medicine called BI 3000202 can help adults with moderate to severe systemic lupus erythematosus (SLE). This phase II study is designed to find the best dose of BI 3000202 for people living with this condition. Participants must have a confirmed diagnosis of SLE with specific disease activity and antibody markers. Participants are randomly divided into five groups. Four groups receive varying doses of BI 3000202, while one group receives a placebo that looks like the real medicine but contains no active drug. All participants continue their usual SLE treatments during the study. The tablets are taken daily for one year. During the study, participants visit the study site regularly for health checkups and to monitor any side effects. Researchers measure the treatment's effectiveness by the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at week 32. The total participation time is a bit longer than one year, during which safety and health are closely observed and compared between groups.

This research aims to evaluate three new tests that may simplify measuring frailty in patients preparing for major surgery for bowel cancer. Frailty, characterized by weight loss, low energy, weakness, slow walking speed, and low activity, is common in older patients and increases risks of death and complications after surgery. Many older patients are denied surgery because current clinical tests for frailty are complex and time-consuming. This study seeks to gather evidence to support future improvements in care for frail cancer patients. Participants will undergo baseline assessments including functional, frailty, nutritional, and quality of life questionnaires, along with a blood test for metabolomic analysis. A subgroup of 30 participants—half frail and half non-frail—will wear a digital motion device for seven days before surgery. These assessments will mostly take place during routine clinic or hospital visits. The study compares these new tests against standard clinical measures. Participants will be monitored for frailty levels before surgery and after, with researchers tracking outcomes such as mortality and adverse events. The study will measure how accurately the digital motion data, tissue senescence, and blood biomarkers predict frailty and surgical outcomes. The total participation includes baseline testing, device use for some, and follow-up to observe post-operative frailty and complications until December 1, 2029.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are evaluating the efficacy, safety, and tolerability of povetacicept in adults with primary membranous nephropathy (pMN), a kidney condition confirmed by biopsy. This study is a Phase 2b/3 adaptive, randomized, active-controlled trial comparing povetacicept with a calcineurin inhibitor treatment. Participants will receive either povetacicept, given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The study aims to compare these treatments in managing pMN over the course of the trial. Throughout the study, researchers will monitor participants for the proportion who achieve complete clinical remission by Week 104. Safety, tolerability, and other clinical outcomes will also be assessed to understand the treatments' effects over time.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) affects millions worldwide and is a leading cause of kidney failure. This research aims to evaluate whether metformin, a common diabetes medication, can be repurposed to slow kidney function decline in adults with early-stage ADPKD. The trial addresses the limited treatment options currently available and the significant impact of ADPKD on quality of life, anxiety, and depression. Participants will be randomly assigned to receive either extended-release metformin or a placebo with inactive tablets identical in appearance. This global Phase III study plans to enroll 1,174 adults aged 18 to 70 years diagnosed with ADPKD. The study will carefully monitor kidney function over 24 months to assess the effects of metformin on disease progression. During the study, participants will undergo evaluations including kidney function tests measured by estimated glomerular filtration rate (eGFR). Researchers will track changes over two years to determine if metformin slows kidney decline. Safety assessments and adherence monitoring will also be part of the study to ensure participant well-being throughout the trial period.