Fremantle

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, in adults with moderate to severe atopic dermatitis (AD). AD is a long-lasting itchy red rash caused by a skin reaction. The study seeks participants aged 18 or older who have had AD for at least six months, have not responded well to topical treatments, and are considered by their doctors to have moderate to severe AD. The study is divided into four stages. In Stage 1, participants received either PF-07275315, PF-07264660, or placebo; this stage is complete. In Stage 2, participants receive either PF-07275315 or placebo. In Stage 3, participants who previously received anti-inflammatory proteins will receive PF-07275315 or placebo. In Stage 4, participants will receive PF-07264660 or placebo. All treatments are given as multiple shots under the skin at the clinic during each stage. Placebo shots look like the study medicines but contain no active drug. Participants will be involved for up to 40 weeks (10 months) in Stages 1, 2, and 4, and up to 52 weeks (13 months) in Stage 3. Researchers will regularly assess their skin condition, measure improvements, and monitor for any side effects. The main outcome is the number of participants achieving at least 75% improvement in their eczema severity score at week 16. Participants will attend scheduled visits, lab tests, and follow study procedures throughout the study.

Researchers are investigating whether personalized soft tissue balance data from the NextAR navigation system improves outcomes for patients undergoing medially stabilized total knee arthroplasty (TKA). This prospective, randomized, single-blinded study aims to assess if NextAR data helps achieve prosthesis implants that closely mimic native knee alignment, potentially leading to better knee function and patient satisfaction. The study evaluates clinical utility, knee kinematics, and patient outcomes following TKA in individuals with end-stage osteoarthritis. Participants are randomly assigned to receive the GMK Sphere knee implant either with conventional instrumentation (control group) or with guidance from the NextAR system (NextAR group). The NextAR system provides soft tissue balance patterns during surgery to assist implant positioning. Clinical evaluations and imaging are conducted at multiple time points including before surgery, and postoperatively at 6 weeks, 6 months, 1 year, and 2 years. CT scans are performed preoperatively and at 6 weeks post-surgery, while X-rays are taken at baseline and at the 1-year follow-up. Throughout the study, patients complete standardized assessments such as the Forgotten Joint Score, Oxford Knee Score, International Knee Documentation Committee score, and the European Quality of Life Five Dimensions questionnaire. Researchers also use 3D gait analysis to assess knee movement. The main outcome measured is whether NextAR system data contributes to improved patient outcomes using the Forgotten Joint Score at different postoperative intervals. Follow-up and safety monitoring continue for up to 2 years after surgery.

Researchers are working on the ETHOS II Project to improve care for people with hepatitis C virus (HCV) in drug treatment clinics and needle and syringe programs (NSPs) across New South Wales and Australia. The project aims to create a framework for better HCV screening and treatment services in these settings nationally. It is a collaborative effort involving multiple health and research organizations, focusing on individuals with a history of injecting drug use or those receiving opioid substitution therapy. The study involves an intervention that includes on-site HCV RNA testing, liver fibrosis assessment, and helping participants connect to care to increase the use of direct-acting antiviral therapy for HCV. Participants will undergo procedures such as Hepatitis C testing, fibroscan, questionnaires, and clinical assessments during "campaign days." A sub-study will invite 550 participants to provide blood samples to evaluate new diagnostic tests for chronic HCV infection. The project also includes interviews with policy makers, clinicians, and patients to understand challenges in HCV care, and the development of an education and training program to improve workforce skills and HCV care quality. Participants will be recruited from drug treatment clinics, general practices, and NSP programs. They will complete surveys and may consent to link their data with health databases for ongoing study. The main outcome measured is the number of participants starting anti-HCV treatment each year for up to three years. Researchers will monitor participant health records and follow up through medical record reviews, ensuring thorough tracking of treatment initiation and care engagement throughout the study duration.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are evaluating the use of cemiplimab, an immune system-boosting drug, to treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by attaching to a protein called PD-1 on immune cells, helping them kill cancer cells. This Phase 3 study compares the effectiveness of cemiplimab injected directly into the skin lesion against standard surgical removal of the tumor. The research also examines the side effects that cemiplimab may cause. Participants will either receive cemiplimab injections into the tumor or undergo primary surgery, which involves removing the tumor with precise margin control methods like Mohs surgery. The study focuses on lesions sized between 1 cm and 2 cm located on the head, neck, hand, or pre-tibial area. Those undergoing surgery will have their tumors completely removed with margin assessment to ensure thorough treatment. During the study, investigators will monitor participants for event-free survival (EFS), meaning the length of time without cancer progression or other events, assessed up to one year and up to three years. Researchers will also track side effects and overall treatment response. Participants need to have good general health, adequate liver, kidney, and bone marrow function, and be physically able to undergo surgery if assigned to that group. The study aims to provide important information on how well cemiplimab works compared to surgery for early-stage CSCC.

Researchers are evaluating the impact of scaling up finger-stick point-of-care testing for hepatitis C virus (HCV) to improve diagnosis and treatment rates. This observational cohort study focuses on people at risk of HCV infection, including those attending services like drug treatment clinics, needle and syringe programs, prisons, mental health services, and homelessness support. The study aims to address declining treatment uptake and challenges caused by COVID-19, contributing to national efforts to eliminate HCV by 2030. Participants will be offered finger-stick point-of-care testing for HCV antibodies, with results available within 1 to 20 minutes. If the antibody test is positive, a point-of-care HCV RNA test will be done to detect active infection. Those previously infected or treated will directly receive the HCV RNA test. No treatment is provided within the study, but participants with active infection will be connected to standard care services for clinical assessment and treatment initiation. Participants attend a single visit for testing and to complete a self-administered survey. The study will monitor the proportion of participants who start HCV treatment within 12 weeks after testing positive for HCV RNA. Researchers will also link survey data to health records to assess long-term impacts of expanded HCV testing and treatment. This approach aims to improve diagnosis rates and support efforts to reduce HCV-related health burdens.