Peterborough

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are investigating the long-term safety and effectiveness of APG777, a treatment for moderate-to-severe atopic dermatitis (AD), in patients who have already completed an initial APG777 study. This phase 2, multicenter, double-blind study focuses on those who may benefit from extended treatment with APG777 to better understand its ongoing effects and safety over time. The study includes three main periods: a screening visit that occurs at the end of the previous study's maintenance period, an extended treatment period where participants receive APG777 subcutaneous injections every 12 or 24 weeks, and a post-treatment follow-up period. Participants will continue using their chosen non-medicated moisturizer from the previous study throughout this extension. During the study, participants' health and response to treatment will be closely monitored, including tracking any treatment-emergent adverse events for up to three years. Researchers will assess the long-term safety and efficacy of APG777 while ensuring participants remain compliant with study protocols. This ongoing observation aims to provide detailed information on how APG777 affects patients over extended use.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Hidradenitis Suppurativa (HS) is a skin condition causing deep, painful bumps that appear where skin rubs together. These bumps can swell, become red, and sometimes fill with pus, turning into abscesses that may burst. Over time, HS can lead to scars and tunnels on or under the skin. This study aims to evaluate how safe and effective the drug zasocitinib is for adults with moderate to severe HS, comparing it to a placebo in a Phase 2 trial. Participants will receive either zasocitinib or a placebo capsule daily for 16 weeks. The placebo looks the same but contains no medicine. After this initial 4-month period, all participants, including those who first received placebo, will be offered zasocitinib for up to an additional 8 months. Throughout the study, participants will visit the clinic 12 times for treatment and monitoring. During the visits, researchers will assess treatment response, including the percentage of participants achieving a 75% reduction in HS signs at week 16. They will also monitor safety and tolerance of the medication. Participants will undergo various evaluations such as physical exams, lab tests, and questionnaires to track disease progress and side effects. The study includes careful follow-up to ensure participant safety and to gather detailed information on the drug's effects over the total study duration of up to 12 months.

Vitiligo is a long-term autoimmune condition where the immune system mistakenly attacks skin cells that produce pigment, leading to patches of skin that lose color. This study focuses on adults with nonsegmental vitiligo, where symmetrical patches of depigmentation appear on both sides of the body. The trial aims to evaluate the safety, effectiveness, and tolerability of zasocitinib in treating this condition in adults aged 18 to 75 years. Participants will receive either zasocitinib capsules or placebo capsules that look identical but contain no medicine. The treatment period lasts up to one year (52 weeks). Those initially receiving placebo will switch to zasocitinib after about six months. During the study, participants will visit the clinic 11 times for treatment and monitoring. Throughout the trial, researchers will assess how well participants respond to treatment by measuring improvement in facial vitiligo using a standardized scoring index at baseline and after 24 weeks. Additional evaluations include safety monitoring and adherence to the study procedures. Participants will undergo clinical assessments, laboratory tests, and provide informed consent before starting the trial.

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 the medicine ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years. Alopecia areata is a condition that causes significant hair loss. This study aims to compare how well ritlecitinib works for hair regrowth compared to a placebo, along with assessing its safety and impact on patient quality of life. The study includes three groups: one receiving a higher dose of ritlecitinib, one receiving a lower dose, and one receiving a placebo. All treatments are given as oral capsules taken once daily at home for 24 weeks. Participants eligible for the study have at least 50% scalp hair loss and specific vaccination or virus exposure history. After the 24-week treatment, participants may join a long-term extension study or complete a 4-week follow-up if not eligible. Participants will attend 8 clinic visits during the 6-month study and receive about 8 phone calls for monitoring. Assessments include measuring scalp hair loss using the Severity of Alopecia Tool (SALT), evaluations of eyebrows and eyelashes, patient-reported outcomes on anxiety, depression, and quality of life, and pharmacokinetic sampling. Safety monitoring is ongoing to watch for potential risks associated with ritlecitinib.

Researchers are studying how well lebrikizumab works for adolescents and adults with moderate atopic dermatitis (eczema) who have a high level of itchiness and limited areas affected on the body. The study focuses on participants who have had eczema for at least one year and aims to measure improvements in skin condition and itch severity. This is a Phase 4, open-label, single-arm trial involving individuals aged 12 and older. Participants will receive lebrikizumab through subcutaneous injections. The treatment period lasts for 24 weeks (6 months), during which the medication is administered as per the study protocol. The entire participation, including screening and follow-up, spans approximately 38 weeks (9 and a half months). During the study, participants will undergo regular assessments including skin evaluations and itch severity ratings to track changes from baseline. Researchers will measure the percentage of participants achieving at least a 75% improvement in eczema severity or a 4-point reduction in itch intensity by week 16. Safety and adherence to treatment will also be monitored throughout the study duration.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.