Basingstoke

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

Researchers are investigating the mechanisms that cause resistance to breast cancer treatments in participants with different types of breast cancer, including HER2 positive, hormone receptor positive, and triple negative breast cancer. The study focuses on analyzing tumor and blood samples to understand changes in specific proteins, genes, and immune factors related to treatment resistance. This research is a phase 4 multi-cohort translational study designed to explore these resistance mechanisms in detail. Participants will undergo a procedure to collect tumor tissue, such as a biopsy, along with a blood draw on the same day. The study includes several cohorts based on the type of breast cancer and resistance status. Some cohorts focus on acquired resistance with tumors growing after at least six months of therapy, while another cohort studies primary resistance with tumors growing after 4 to less than 6 months of therapy. Archival tumor tissue is also required for comparison. During the study, researchers will monitor changes from baseline in HER2 protein and gene levels, estrogen receptor protein levels, genes related to resistance, and the tumor immune environment. These changes will be measured at the time of disease progression or recurrence. Safety and eligibility will be carefully assessed, and participants must have accessible progressive tumor lesions for tissue collection. The study aims to deepen understanding of breast cancer treatment resistance over a period of at least six months for most cohorts.

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 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.

Bowel cancer is a common and deadly disease in the UK, causing many deaths due to cancer spreading to other organs, known as metastases. This research investigates how colorectal cancer spreads, focusing on whether it travels through blood vessels instead of the lymphatic system, which is the current assumption used to guide additional treatments after surgery. The study aims to improve how patients who need extra treatment are identified by studying genetic material from tumors and metastases. This is a retrospective, non-interventional study using tissue samples collected during patients' routine care. Researchers will analyze these archival samples to compare cancer spread through extramural venous invasion (EMVI) and tumor deposits with spread through lymph nodes. By reconstructing genetic 'family trees' of the tumors and related tissues, the study will test if the blood vessel route plays a bigger role in metastasis than lymph nodes. Participants have already undergone surgery to remove the colon or rectum and any distant metastases. The study uses existing imaging from CT or MRI scans and tissue samples from these patients to perform detailed analyses. The primary outcome is to compare how often EMVI and tumor deposits versus lymph nodes are linked to distant metastases one year after the last patient is registered. This research may change how future treatment decisions are made worldwide.

Researchers are evaluating the use of biparametric MRI (bpMRI) and image-fusion targeted biopsies to detect prostate cancer in men at risk. The study aims to determine if bpMRI can be recommended as an alternative to the longer multiparametric MRI (mpMRI) for identifying clinically significant prostate cancers. It also compares image-fusion targeted biopsy with visual-registration targeted biopsy to see which method better detects significant prostate cancer in patients with suspicious MRI findings. Participants will undergo one of two types of MRI scans: a longer 30-40 minute MRI that uses a contrast dye called gadolinium (commonly used in the NHS), or a shorter MRI without contrast. If the MRI shows suspicious areas, participants may then have a prostate biopsy. Biopsies are performed either by visual registration, where the biopsy needle placement is guided by the operator’s judgment using MRI and ultrasound images, or by image fusion, where MRI images are overlaid on live ultrasound using software to guide the biopsy needle more precisely. During the study, patient scans and biopsy results will be closely monitored and analyzed to measure how many clinically significant cancers are detected within 12 weeks of enrollment. Researchers will collect MRI images, perform biopsies if indicated, and evaluate the biopsy samples under a microscope. The study includes safety monitoring and aims to inform future NHS practices for prostate cancer diagnosis. Male participants aged 18 and older who are referred for prostate MRI due to abnormal exams or elevated PSA levels are eligible to join.

Researchers are investigating the use of Magnetic Resonance Tumour Regression Grade (mrTRG) as a new imaging biomarker to guide treatment decisions in patients with locally advanced rectal cancer. This phase III trial in the UK is unique in offering a 'watch and wait' approach for patients who respond well to pre-operative treatment, potentially avoiding surgery and preserving quality of life. The study aims to validate mrTRG to differentiate between good and poor responders to radiotherapy and help tailor ongoing treatment and surveillance accordingly. Participants will be randomly assigned to one of two groups. The control group will receive standard management based on national guidelines and clinical assessments after treatment, including routine MRI scans without mrTRG reporting. The intervention group will have post-treatment MRI scans evaluated by specially trained radiologists to assess mrTRG grades. Patients classified as good responders (mrTRG 1 or 2) will be offered a watch and wait approach to avoid surgery, while poor responders (mrTRG 3 to 5) will have their cases reviewed by a local colorectal multidisciplinary team for further treatment planning. During the study, all participants will undergo routine MRI scans following standardized protocols and complete quality of life questionnaires at registration, 3 years, and 5 years. Researchers will monitor outcomes for up to five years, focusing on whether surgery can be safely avoided in good responders and tracking long-term effects on health and survival. The study does not mandate specific chemotherapy or investigational treatments, allowing local teams to decide additional therapy as needed.

This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (\>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.

Researchers are investigating the safety and effectiveness of adding olaparib, a PARP enzyme inhibitor, to platinum-based chemotherapy given before surgery in patients with triple-negative breast cancer (TNBC) and/or those with germline BRCA (gBRCA) mutations. This randomized phase II/III trial aims to see if this combined treatment improves the rate of pathological complete response (pCR) at surgery while monitoring safety outcomes. The study plans to enroll at least 780 patients, including a minimum of 220 with gBRCA mutations. Participants will receive a minimum of 21 weeks of chemotherapy followed by surgery. The treatment includes oral olaparib tablets taken twice daily about 12 hours apart, alongside intravenous paclitaxel and carboplatin given in cycles every three weeks. During the trial, standard supportive care like granulocyte-colony stimulating factor and anthracyclines may also be administered. For those with residual disease after initial treatment, there is an option to join a sub-study involving additional chemotherapy drugs. Throughout the study, patients will undergo screenings including BRCA mutation testing and various tumor marker assessments. Safety will be closely monitored by the trial team and an independent committee. The main outcomes measured are treatment-related side effects, pCR rates after surgery, and long-term efficacy assessed over approximately 5.5 years, with follow-up planned for up to 10 years after surgery.