Portsmouth

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

Researchers are evaluating the safety and side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This Phase 2 study compares LY4005130 with a placebo to understand how well the drug is tolerated. Participants have NSV affecting certain areas of their body and face, with the condition being either active or stable for at least 3 months. Participants will receive LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The treatment phase lasts 24 weeks, during which the effects and safety of the drug will be monitored. The entire study, including screening, will take about 48 weeks. Throughout the study, participants will undergo blood tests to assess how their body processes the drug and how the drug affects their body. Researchers will measure the percentage of participants achieving significant improvement in facial vitiligo after 24 weeks. Safety and side effects will be followed carefully during treatment and the study period.

Researchers are evaluating how well LY4005130 works in adults with severe alopecia areata, a condition causing significant hair loss. This Phase 2 study compares LY4005130 with a placebo to assess its effectiveness, safety, and side effects. Blood tests will be conducted to understand how the body processes the drug and how the drug affects the body. The study drug, LY4005130, and placebo are both given intravenously into a vein in the arm. The treatment period includes administration of these study drugs under controlled conditions. The study lasts about 48 weeks in total, which includes a screening period before treatment. Participants will be involved in various assessments such as blood tests and evaluations of hair loss severity using the Severity of Alopecia Tool (SALT). The main outcome measured is the percentage of participants who achieve a SALT score of 20 or less by week 24. Safety and tolerability will be monitored throughout the study, with follow-up visits scheduled during the 48-week period.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps (abscess and inflammatory nodule (AN) count) with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study). Participants will: * Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.

This research aims to evaluate the effectiveness and safety of a single dose of IPN10200 compared to a placebo in adults with moderate to severe glabellar lines, which are wrinkle-like lines that appear between the eyebrows and may affect appearance and confidence. The study includes a double-blind phase to assess initial treatment effects and an open-label phase to evaluate the safety and effectiveness of repeat doses over time. This Phase III study focuses on adult participants aged 18 to 80 years with moderate to severe lines who are dissatisfied with their appearance. Participants will receive injections of either IPN10200 or placebo during the first treatment cycle in the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase will receive IPN10200, with some eligible for up to four treatment cycles. Each treatment involves local injections of a lyophilised powder solution into several sites across the glabellar region. The study consists of three periods: a screening period of up to 20 days, a treatment period with multiple visits especially in the first month followed by monthly visits, and a 24-week follow-up after the last injection. Throughout the study, participants will have health evaluations including blood tests, physical exams, clinical assessments, and electrocardiograms. They will complete questionnaires and keep diaries to monitor their condition and response to treatment. The main outcome measured is the percentage of participants showing improvement in glabellar lines by week 4. Safety and long-term effects will be monitored for up to 107 weeks, with participants free to withdraw consent at any time.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in people with moderate-to-severe plaque psoriasis who are also overweight or obese with at least one related health condition. This study is a phase 4, open-label, single-arm trial focused on real-world clinical practice. The goal is to see how well this combination works over a 12-month period. Participants will continue treatment with ixekizumab and start tirzepatide, which is given by injection under the skin. To join, participants must have started ixekizumab about three months before adding tirzepatide. The study monitors treatment beginning at baseline and follows participants for up to one year to assess outcomes. During the study, researchers will measure how many participants improve their skin-related quality of life using the Dermatology Life Quality Index and how many achieve at least a 10% weight reduction after 12 months. Participants will be regularly evaluated to track these outcomes and monitor safety throughout the study period.

Researchers are investigating treatments for people with newly diagnosed Stage I HER2-positive invasive breast cancer. This phase II study compares two different combinations of HER2-targeted therapies after surgery to evaluate their effects and side effects. The study focuses on whether trastuzumab-emtansine (T-DM1) followed by subcutaneous trastuzumab has fewer side effects than the standard treatment of paclitaxel combined with subcutaneous trastuzumab, while also looking at long-term benefits and disease-free survival. Participants will be randomly assigned to one of two groups. One group will receive trastuzumab-emtansine (T-DM1) through intravenous infusion followed by subcutaneous trastuzumab injections. The other group will receive paclitaxel through intravenous infusion combined with subcutaneous trastuzumab injections. Treatments will be given for a total of one year. T-DM1 is a targeted therapy that combines an antibody with chemotherapy to directly attack cancer cells. During the study, participants will undergo screening, laboratory tests, and regular follow-up visits over five years after treatment ends. Researchers will monitor side effects during the first 18 weeks of treatment and measure disease-free survival up to 72 months. The study includes assessments of heart function, blood tests, and collection of tumor tissue for research. About 500 people are expected to participate.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.