Quincy

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

This research aims to evaluate the safety and effectiveness of Eloralintide (LY3841136) in adults who have osteoarthritis knee pain and are either obese or overweight. Conducted under a master protocol supporting two independent studies, the trial focuses on participants with a body mass index of 27 or higher who experience knee osteoarthritis symptoms such as pain and stiffness. The study is a Phase 3 randomized, double-blind, placebo-controlled trial designed to provide clear evidence on this treatment's impact. Participants will receive either Eloralintide or a placebo, both administered by subcutaneous injection once weekly. The study includes a screening phase followed by about 75 weeks of participation. The treatments aim to assess changes in body weight and knee pain severity. The study excludes participants with recent surgeries for obesity, diabetes, active knee infections, recent serious heart events, or recent use of weight loss medications. During the study, participants will be regularly monitored for changes in body weight and knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. Researchers will track safety and effectiveness through scheduled visits and assessments over the approximately 75-week period. The trial will help determine if Eloralintide provides benefits in managing osteoarthritis knee pain alongside obesity or overweight conditions.

High blood pressure (hypertension) affects over 100 million people in the US, leading to serious health risks like stroke, heart attack, and kidney disease. Managing hypertension well requires ongoing patient involvement for monitoring and treatment adjustments, but many patients do not have their blood pressure under control. This research aims to improve blood pressure control by testing two different approaches in urban, safety-net primary care settings that serve diverse populations facing disparities in hypertension outcomes. The study evaluates and compares two interventions: remote blood pressure monitoring (RBPM) alone, and RBPM combined with a multilevel intensification intervention (MII) that includes team-based strategies such as clinician decision support and medication management improvements. These interventions will be rolled out sequentially across nine sites using a cluster randomized stepped-wedge design, allowing each site to experience both approaches. Data on patient-reported outcomes like activation, medication adherence, and trust in medical care will also be collected. Participants will be monitored regularly with blood pressure measurements at baseline and every 3 months for up to 54 months. Researchers will track treatments received and assess patient activation at several time points up to 54 months. The study uses both quantitative and qualitative methods to understand the effectiveness and implementation of the interventions. Participant involvement includes primary care visits and ongoing data collection to evaluate hypertension control and quality of care over the study duration.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion, containing 4% serine protease inhibitor, when added to the standard treatment for Netherton syndrome, a rare skin disorder. This multicenter, open-label study includes subjects aged 14 years and older who have a clinical diagnosis of Netherton syndrome and visible lesions on their arms or lower legs. Participants may already be on stable systemic therapy for their condition before starting the study. The study involves applying QRX003 lotion to the affected skin areas as part of the treatment regimen. The lotion contains an active drug designed to inhibit serine protease activity. Subjects will continue their current stable treatments while adding the study lotion. There is no placebo group, and the study is conducted openly, meaning both participants and researchers know the treatment being used. During the study, participants will be monitored up to week 16 for changes in skin condition, itch severity, and overall satisfaction with the treatment. Researchers will assess skin lesion improvements, reductions in itch scores, and the need for additional rescue therapies. Safety will be closely observed through adverse event monitoring and local skin reactions. The study includes genetic testing to confirm diagnosis if not previously done and requires females of childbearing potential to have negative pregnancy tests and use effective birth control throughout the study and for three months afterward.

Researchers are evaluating the safety, tolerability, and effectiveness of a 4% QRX003 lotion applied twice daily for 12 weeks in people with Netherton syndrome, a genetic skin condition. This multicenter, open-label study focuses on treating affected skin areas covering about 50% or more of the body surface, excluding the scalp. The study includes participants aged 4 years and older and spans phases 2 and 3 to better understand this treatment's potential benefits and risks. Participants will apply QRX003 lotion to all affected skin areas twice daily for a total of 12 weeks. The treatment area excludes the scalp but must cover approximately half or more of the body surface area. The study does not include a placebo or comparison group as it is open-label, meaning all participants receive the active treatment. During the study, participants will be closely monitored for safety and treatment effects. Researchers will measure the proportion of subjects who show at least a 1-point improvement on the Investigator Global Assessment scale by week 12. Participants will provide informed consent, and female participants of childbearing potential will undergo pregnancy testing and use birth control during and after the study. The total participation includes screening, treatment, and follow-up to ensure safety and efficacy over the 12-week period.