Fremantle

Researchers are studying BBT001, a drug candidate for treating moderate to severe atopic dermatitis AD, in a Phase 1 randomized, double-blinded, placebo-controlled trial involving healthy volunteers and adult patients with AD. The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001. Participants will receive either a single or multiple ascending doses of BBT001 or placebo. Healthy volunteers will receive single and multiple doses, while adult patients with moderate to severe AD will receive multiple doses. The study includes several parts A, B, C, D, and E with different dosing regimens to assess these effects. Throughout the study, participants will be monitored for adverse events, changes in blood parameters, vital signs, physical exams, and ECG readings for up to 169 days after the first dose. Pharmacokinetic and immunogenicity measures will also be collected at specified time points. The total duration of monitoring varies by study part but can last up to approximately 24 weeks post-dose.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, for treating moderate to severe atopic dermatitis AD, a long-lasting itchy red rash caused by a skin reaction. The study includes adults aged 18 years or older who have had AD confirmed for at least six months and have not responded effectively to topical treatments. The study is a Phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. The study consists of multiple stages. In Stage 1, participants received PF-07275315, PF-07264660, or a placebo for 12 weeks. Stage 2 involves PF-07275315 or placebo injections over 12 weeks. Stage 3 includes participants who previously received anti-inflammatory proteins, with treatment lasting up to 32 weeks. Stage 4 involves PF-07264660 or placebo injections for 12 weeks. All injections are given as multiple shots in a clinic setting. Participants will be in the study for up to 40 weeks in Stages 1, 2, and 4, and up to 52 weeks in Stage 3. Researchers will monitor skin improvements using measures such as the EASI75 score, which reflects a 75% improvement in eczema severity, along with other skin assessments, vital signs, ECG, and laboratory tests. Safety and treatment effects will be closely observed throughout the study period.

Researchers are evaluating the NextAR navigation systems clinical utility in patients undergoing total knee arthroplasty for end-stage osteoarthritis. This prospective, randomized, single-blinded study aims to determine if personalized soft tissue balance data provided by the NextAR system can help prosthesis implants better resemble native knee alignment and improve patient outcomes and knee motion. Participants will undergo knee replacement surgery with either conventional instrumentation or the NextAR guidance system using the GMK Sphere implant. Clinical evaluations, including CT scans and X-rays, will be performed at various points before and after surgery. Outcomes assessed include soft tissue balance, knee kinematics via 3D gait analysis, and patient-reported measures such as the Forgotten Joint Score, Oxford Knee Score, International Knee Documentation Committee score, and quality of life questionnaires. Participants will be evaluated preoperatively and postoperatively at 6 weeks, 6 months, 1 year, and 2 years. Assessments include clinical questionnaires, imaging studies, and gait analysis to measure knee function and alignment. The primary outcome focuses on changes in the Forgotten Joint Score over time. The study duration spans up to two years following surgery with multiple follow-up visits to monitor clinical progress and knee performance.

Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.

Researchers are evaluating a drug called cemiplimab for treating early-stage Cutaneous Squamous Cell Carcinoma CSCC, a type of skin cancer. Cemiplimab helps the immune system attack cancer cells by targeting a protein called PD-1 on immune cells. The studys main goal is to compare how well cemiplimab works when injected directly into the lesion versus standard surgery. Participants will be randomly assigned to receive either cemiplimab injected into the lesion or undergo primary surgery using techniques like Mohs surgery or other complete margin assessment methods. The study will assess side effects and how well cemiplimab performs compared to surgery in treating the cancer. During the study, participants will be monitored for event-free survival up to 3 years. Researchers will also evaluate lesion response, treatment-related adverse events, and sizes of surgical or biopsy defects. The total participation period extends up to 3 years, with regular assessments to track safety and treatment effectiveness.

Researchers are evaluating whether increasing the use of finger-stick point-of-care testing for hepatitis C virus HCV infection improves diagnosis and treatment rates. The study focuses on people at risk for HCV infection, recruited from various settings such as drug treatment clinics, needle and syringe programs, homelessness services, mental health services, prisons, and mobile outreach. This observational cohort study aims to address challenges in HCV elimination caused by reduced treatment uptake and barriers in current diagnostic pathways. Participants will attend a single visit to receive point-of-care HCV testing using finger-stick methods. Testing includes rapid HCV antibody tests, and if positive, further HCV RNA testing is performed to detect active infection. Those with detectable HCV RNA will be linked to standard care for further assessment and treatment outside the study. Participants will complete a self-administered survey during the visit. No treatment is provided as part of this study. During the study, researchers will measure how many participants with active HCV infection start treatment within 12 weeks after testing. They will also evaluate acceptance of testing, prevalence of active infection, treatment initiation timing, treatment completion, and virus clearance rates up to 52 weeks following testing. Data from surveys will be linked to administrative records to assess long-term health outcomes. Participation involves only one study visit for testing and survey completion.