Norwich

Researchers are evaluating rilzabrutinib as a treatment for adults with active Immunoglobulin G4-related Disease IgG4-RD in a Phase 3, randomized, double-blind, placebo-controlled study. The main goal is to measure the time to clinical disease flare and assess other important outcomes like flare-free rates, disease activity control, and safety over a 52-week treatment period. This study includes participants aged 18 and older diagnosed with IgG4-RD, aiming to provide detailed information on the drugs effects compared to placebo. Participants will be randomly assigned to receive either rilzabrutinib tablets or placebo tablets taken orally during a 52-week double-blind treatment period. The study also includes a screening period of 4 to 6 weeks before treatment and a 2-week follow-up afterwards. An optional open-label extension lasting up to 108 weeks is available for further evaluation. Glucocorticoid rescue treatment may be used as needed during the study, and participants are expected to taper off glucocorticoids after starting the study drug. Throughout the study, participants will attend up to 16 visits during the double-blind phase and up to 9 additional visits if they join the extension. They will undergo various evaluations including imaging procedures such as CT, MRI, PET, or ultrasound to monitor disease activity. Researchers will monitor treatment-emergent adverse events, laboratory results, ECGs, and disease flare rates to assess rilzabrutinibs safety and effectiveness. Overall, participation lasts up to 60 weeks, with extended monitoring in the optional open-label phase.

Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia BPD, a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drugs effects over time.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatments effects and safety.

Researchers are exploring new treatments for radiographic axial spondyloarthritis r-axSpA, a type of arthritis causing pain, stiffness, and swelling in the spine and pelvic joints. This study aims to find out if different doses of tulisokibart, a study medicine, can improve symptoms of r-axSpA better than a placebo. A placebo looks like the medicine but contains no active drug, helping researchers understand tulisokibarts effects. Participants will be randomly assigned to receive either a high, medium, or low dose of tulisokibart, or a placebo, all given by subcutaneous injection. The study includes a 16-week placebo-controlled period followed by a 124-week long-term extension, which has a 40-week main extension and an 84-week optional extension. Participants on low dose or placebo will be rerandomized at week 16 to medium or high doses of tulisokibart. During the study, participants will undergo regular assessments including symptom evaluations, physical function tests, and MRI scans at the start and week 16. Researchers will track response rates, changes in disease activity, pain levels, and quality of life measures. Safety will be monitored throughout, and the study lasts up to about 140 weeks. The main outcome is the percentage of participants achieving a significant improvement in symptoms at week 16.

Researchers are evaluating the effectiveness and safety of once-weekly subcutaneous doses of navepegritide at 100 micrograms per kilogram compared to a placebo in adolescents aged 12 to 18 years with Achondroplasia. The main focus is to measure the annualized growth velocity after a 52-week treatment period. Participants will receive either navepegritide or a placebo through weekly injections under the skin for one year. The study is randomized, double-blinded, and placebo-controlled, ensuring that neither the participants nor the researchers know who receives the active medication or placebo during the 52 weeks. During the trial, participants will be monitored regularly to assess growth and other health parameters. Researchers will measure growth rates and height z-scores over the course of the year. Safety and any side effects will be closely observed throughout the study. The trial is sponsored by Ascendis Pharma AS and aims to provide detailed information about the effects of navepegritide in this adolescent population.

Researchers are evaluating the effects of pelacarsen TQJ230, given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoproteina levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoproteina levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants well-being during the entire study period.

Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain NMPP related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 bcg on heart and lung outcomes in people with chronic obstructive pulmonary disease COPD who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate GFF MDI 14.49.6 bcg. The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of new drugs or drug combinations given around the time of surgery in adults with locally advanced gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not been treated before. This phase II, open-label study includes multiple sub-studies to assess different novel treatments. Participants are assigned to sub-studies based on the recommended dose determined by a safety review. Participants receive one of three treatment plans that combine novel drugs and chemotherapy before surgery neoadjuvant and after surgery adjuvant. One group receives AZD0901 plus Rilvegostomig with either 5-FU or Capecitabine another receives Trastuzumab Deruxtecan T-DXd plus Rilvegostomig with 5-FU or Capecitabine the third group receives Rilvegostomig plus FLOT chemotherapy. After initial combination therapy, all groups continue with Rilvegostomig alone in the adjuvant phase. Treatments are given through intravenous infusions or orally, depending on the drug. During the study, participants undergo surgery as planned and are monitored for side effects, tumor response, and survival outcomes up to 38 months. Researchers collect data on adverse events, tumor shrinkage, surgery success rates, event-free and disease-free survival, and overall survival. Blood samples are taken to measure drug levels and immune responses. Participants are followed closely to assess treatment safety and effectiveness throughout the study period.

Researchers are evaluating the combination of Surovatamig AZD0486 plus rituximab compared to standard immunochemotherapy regimens in people with previously untreated follicular lymphoma. This global, randomized, open-label Phase III study aims to assess the effectiveness, safety, and additional benefits of adding Surovatamig to rituximab. The study is sponsored by AstraZeneca and involves participants needing systemic treatment for follicular lymphoma meeting specific criteria. The study has two parts. The first is a safety run-in to find the recommended Phase III dose of Surovatamig with rituximab. The second part is the Phase III comparison where participants are assigned to one of three groups two groups receive different dosing schedules of Surovatamig plus rituximab, and the third group receives one of three standard chemoimmunotherapy treatments with rituximab maintenance. The standard regimens include R-CHOP, R-CVP, or Bendamustine plus rituximab. Participants will be monitored for up to 10 years to evaluate treatment safety, side effects, and responses. Assessments include tracking adverse events, treatment discontinuations, and measuring outcomes like response rates, complete remission, progression-free survival, and overall survival. The study involves regular evaluations to compare how well each treatment works and its impact on participants health over time.