Basingstoke

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are studying HMB-002 in people with Von Willebrand Disease VWD to evaluate its safety, tolerability, how the body processes the drug, its effects, and preliminary efficacy. This first-in-human Phase 12 trial includes three parts to explore different dosing schedules and combinations with standard factor concentrates for various VWD types. The study aims to understand how HMB-002 works alone and alongside standard treatments in participants aged 16 to under 70 years. The study is divided into three parts Part A tests single ascending doses of HMB-002 administered under close monitoring to assess safety and drug behavior over about 12 weeks. Part B evaluates repeated doses over approximately 21 weeks to assess safety and initial effects on bleeding events. Part C studies a single dose of HMB-002 given with a regular factor concentrate dose in participants who already receive this treatment, lasting about 17 weeks. Dosing schedules in Part B depend on Part A results. Participants will be monitored closely throughout the study with safety assessments, blood tests, and evaluations of bleeding rates and factor activity from Day 1 up to Day 113. Researchers will track any treatment-emergent adverse events and measure pharmacokinetic parameters like maximum drug concentration and elimination half-life. They will also assess pharmacodynamic markers such as von Willebrand factor antigen and activity, and factor VIII activity. Overall participation lasts up to about 17 to 21 weeks depending on the study part.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

Researchers are studying mechanisms of resistance to breast cancer therapies in participants with HER2 positive, hormone receptor positive, or triple negative breast cancer. The study focuses on understanding how tumors and blood samples change when the cancer progresses or recurs during treatment. It is a Phase 4 interventional trial designed to investigate these resistance processes in multiple patient cohorts. Participants will be assigned to different groups based on whether they have newly appearing or recurrent metastatic lesions or tumors that continue to grow while on anti-cancer therapy. Tumor tissue and blood samples will be collected during procedures such as biopsies. These samples will be analyzed for changes in HER2 protein and gene levels, estrogen receptor protein levels, genes linked to CDK46 and endocrine resistance, and immune markers like PD-L1 and tumor-infiltrating lymphocytes. Participants will undergo tumor tissue sampling and blood draws when disease progression or recurrence occurs. Researchers will monitor changes from baseline in various proteins, gene copy numbers, and immune features over periods of at least six months or less depending on the cohort. The study will last until September 2026, with ongoing assessments to evaluate resistance mechanisms and disease progression markers. Safety and the ability to complete study procedures will be carefully monitored.

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.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

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.

Bowel cancer is a common and serious cancer, ranking fourth in occurrence and second in cause of cancer deaths in the UK. Despite treatment advances, over 40% of patients die within five years, mostly due to the cancer spreading to other organs, called metastases. Current research focuses on additional treatments before or after surgery, but identifying which patients benefit from these treatments is challenging. This study investigates whether cancer spreads through blood vessels rather than lymph nodes, aiming to improve patient treatment selection. This research is a retrospective, non-interventional study analyzing archival tissue samples collected during routine care. The study examines genetic material from primary tumors, areas of blood vessel invasion called Extramural Venous Invasion EMVI, tumor deposits, lymph nodes, and distant metastases. By reconstructing the tumors family tree, researchers aim to map how the cancer spreads and test if the vascular route is more important than lymph nodes in metastasis. Participants have already provided tissue samples through their medical care, so no new treatments or interventions occur. Researchers will compare genetic and staining profiles of tumor samples and evaluate survival based on tumor origins. The main measure is the link between EMVI, tumor deposits, lymph nodes, and distant metastases, with results expected one year after the last patient is registered. This study is observational and does not involve treatment changes or additional visits.

Researchers are evaluating the use of two types of MRI scans and two biopsy methods to improve prostate cancer diagnosis. The study focuses on whether biparametric MRI bpMRI, which is shorter and does not use contrast dye, can be an alternative to the longer multiparametric MRI mpMRI that uses gadolinium contrast. It also compares image-fusion targeted biopsy, which overlays MRI and ultrasound images during biopsy, with visual-registration targeted biopsy, where biopsy locations are chosen by looking at MRI images separately. Participants first receive either the mpMRI or bpMRI scan. If the MRI suggests cancer, the clinical team decides if a biopsy is needed. Those advised for biopsy undergo either a visual-registration targeted biopsy or an image-fusion targeted biopsy. Both biopsy methods include taking systematic tissue samples to check for cancer. The study does not blind participants or doctors to the MRI or biopsy type used. During the study, participants undergo MRI scans and possibly biopsies based on clinical advice. Researchers collect data on how many clinically significant prostate cancers are detected within 12 weeks of enrollment. They also assess any adverse events related to MRI and biopsy procedures, patient-reported outcomes, and accuracy of cancer detection using different scoring systems. The total duration for outcome assessment is up to 12 weeks after joining the study.

Researchers are studying the use of magnetic resonance tumour regression grade mrTRG as a new imaging biomarker to guide treatment decisions for patients with locally advanced rectal cancer. This phase III trial is unique in the UK as it offers a watch and wait approach for patients showing a good response to preoperative treatment, potentially avoiding surgery. The trial aims to validate mrTRGs ability to identify patients who can safely defer surgery and those who may need intensified treatment, thus tailoring care based on MRI findings. Participants are randomly assigned to one of two groups. The control group receives management according to national guidelines with post-treatment MRI scans interpreted without mrTRG assessment. The intervention group has their post-treatment MRI scans evaluated by specially trained radiologists to assign an mrTRG grade. Patients with a good response mrTRG 1 & 2 are offered a watch and wait approach to avoid surgery, while those with a poor response mrTRG 3-5 have their cases reviewed by a local colorectal multidisciplinary team for further treatment planning and surveillance. Treatment decisions, including chemotherapy use, follow routine clinical practice and are documented but not dictated by the trial. Participants undergo regular monitoring for up to five years, including routine post-treatment MRI scans following the MERCURY protocol and quality of life questionnaires at registration, 3 years, and 5 years. The study assesses if surgery can be safely avoided after a good MRI response and tracks surgical outcomes, survival, quality of life, and economic impact. Additional evaluations include reproducibility of mrTRG readings, molecular and immunological markers, and circulating tumor DNA to predict relapse. This long-term follow-up aims to improve personalized treatment for rectal cancer patients.