Quincy

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are investigating how well and safely Eloralintide LY3841136 works in adults who are overweight or obese and suffer from osteoarthritis pain in the knee. This study supports two independent phase 3 trials under a master protocol, focusing on improving knee osteoarthritis symptoms and body weight management in this population. Participants will receive either Eloralintide or a placebo by subcutaneous injection once weekly. The study follows a randomized, double-blind, parallel design with two separate arms for each independent study. Treatment and observation will last approximately 75 weeks, including the screening period. During the study, participants will undergo various assessments including measurements of body weight, knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, blood pressure, physical function, inflammation markers, and metabolic parameters. Researchers will also track medication use, walk test performance, and other health-related quality of life measures over time to evaluate the effects and safety of Eloralintide.

High blood pressure, also known as hypertension, affects over 100 million people in the US and increases risks like stroke, heart attack, and kidney disease. This research aims to compare different interventions to improve blood pressure control in diverse urban safety-net primary care settings where disparities in hypertension outcomes exist. The study also focuses on patient engagement and overcoming barriers to effective hypertension management through a team approach involving patients, clinicians, and health systems. The trial evaluates two interventions remote blood pressure monitoring RBPM with standardized measurement and treatment protocols, and a multilevel intensification intervention MII involving team-based strategies like clinician support, medication adherence monitoring, and formulary changes. The study uses a cluster randomized stepped-wedge design across multiple sites, sequentially rolling out each intervention to compare their effects and implementation. Both interventions are offered to each site to ensure equitable access. Participants will have their blood pressure and patient-reported outcomes tracked over time, with assessments at baseline and every 3 to 6 months for up to 54 months. Researchers will monitor systolic blood pressure improvements, intervention reach, patient activation, medication adherence, and trust in care providers. Data on treatment intensification and blood pressure control are collected regularly to understand how well each approach works and is implemented in real-world settings.

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.

Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion 4% when added to the usual treatment for people with Netherton syndrome. This open-label study includes participants who are already receiving systemic therapy and aims to understand how QRX003 lotion may impact their condition over time. The study is sponsored by Quoin Pharmaceuticals and combines phases 2 and 3 to gather comprehensive data. Participants will use QRX003 lotion in one of two ways applying it once daily in the morning or twice daily, both for 12 weeks. The lotion contains a serine protease inhibitor as the active drug. This study does not include a placebo group and is non-randomized, so all participants receive the active treatment. Treatment effects and safety are monitored up to 16 weeks. During the study, participants will have regular assessments to measure changes in their skin condition, including the Investigators Global Assessment IGA score, affected skin surface area, and itch severity using the WI-NRS score. Researchers will also assess participant satisfaction with treatment and track any need for additional rescue therapy. Safety will be monitored by recording adverse events and local skin reactions during the entire 16-week period.

Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion at 4% concentration applied twice daily for 12 weeks in people with Netherton Syndrome, a genetic skin condition. This open-label, multicenter study aims to treat affected skin areas covering about 50% or more of the body surface except the scalp. The trial includes children and adults starting from age 4 years. Participants will apply the QRX003 lotion to the treatment areas twice daily for 12 weeks. This investigational treatment is a serine protease inhibitor designed to target the skin issues caused by Netherton Syndrome. The study is open-label, meaning all participants receive the active lotion, and it does not include a placebo group. During the study, participants will be monitored for changes in their skin condition using the Investigator Global Assessment IGA scale at week 12, which is the primary outcome. Secondary measures include improvement in itch severity, and patient and clinician global impressions of change. Safety, tolerability, and adherence to the treatment regimen will be assessed. The total participation time aligns with the 12-week treatment period.

Researchers are evaluating the safety and effectiveness of VDPHL01, an investigational oral drug, in female subjects with Androgenetic Alopecia AGA, a genetic condition causing hair loss due to an excessive response to hormones called androgens. This Phase 3, multi-center, double-blind study aims to better understand treatment outcomes for women aged 18 to 65 with mild to moderate AGA. The study is sponsored by Veradermics, Inc. and includes about 13 months of participation with 11 scheduled visits. Participants will be randomly assigned to one of several groups receiving different regimens of VDPHL01 or placebo. Some groups take VDPHL01 twice daily BID for the entire 12 months, while others begin with placebo or a combination of VDPHL01 once daily QD and placebo before switching treatments after 6 months. The study maintains a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the first 6 months. Throughout the study, participants will attend visits for screening, baseline assessment, and follow-ups at weeks 2, months 1, 2, 4, 6, 8, 10, 12, and 13. Researchers will evaluate hair counts in target areas at 6 months and participants own assessment of treatment benefit. Participants agree to maintain consistent hair length, style, and color, and will have a small tattoo placed on their scalp for photographic monitoring. Safety and treatment effects will be carefully monitored during the study period.