Anniston

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 enicepatide, a dual GLP-1/GIP receptor agonist, to see how well it works and how safe it is for weight management in adults who are obese or overweight and do not have Type 2 diabetes. The study compares different doses of enicepatide with a placebo to understand its effects. Participants must have a body mass index (BMI) of at least 30, or a BMI between 27 and 30 with at least one weight-related health issue such as prediabetes, hypertension, or sleep apnea. Participants will receive once-weekly injections of either enicepatide or a placebo using an integrated drug-device combination product. The treatment is randomized and double-blinded, meaning neither participants nor researchers know who gets the active medication or placebo during the study. The study is a Phase III trial, and treatments continue over a period leading up to week 72. Throughout the study, participants will be monitored for changes in body weight, with the primary measure being the percent change from baseline to week 72. Safety and efficacy will be assessed regularly, and participants will self-administer the injections or receive help if needed. The study also tracks any side effects and overall health status to understand the long-term effects of enicepatide for weight management.

Researchers are investigating new treatments for people living with HIV-1, the most common type of HIV that attacks the immune system. This Phase 1 trial evaluates the effects of a study medicine called MK-4646 when taken with standard HIV treatments Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Dolutegravir (DTG). The study aims to understand how MK-4646 affects the levels of these antiretroviral drugs in the blood over time and to assess its safety and tolerability in healthy adults. Participants will receive oral medications including the single-tablet combination of BIC/FTC/TAF, the oral tablet Dolutegravir, and the oral capsule MK-4646. The study focuses on the interaction between MK-4646 and the other HIV drugs by monitoring drug concentrations. Treatments will be given according to the trial schedule, and participants will be closely observed for any side effects or health concerns. During the study, participants will have blood samples taken to measure the concentration of each drug over approximately 72 hours after dosing. Researchers will track the area under the concentration-time curve (AUC) for Bictegravir, Emtricitabine, Tenofovir Alafenamide, Tenofovir, and Dolutegravir. Safety and tolerability will also be monitored throughout the trial to ensure participant well-being. The study includes healthy adults aged 18 to 60 years with a body mass index between 18 and 32 kg/m².

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are investigating the safety and tolerability of LY4213663 in both healthy individuals and people with rheumatoid arthritis (RA). This Phase 1 study aims to understand how the body processes LY4213663 and to monitor any side effects that may occur during treatment. The trial lasts about 33 weeks, not including the screening period. Participants will receive LY4213663 or a placebo through injections either under the skin (subcutaneously) or into a vein in the arm (intravenously). The study includes single and multiple ascending doses for healthy participants and two open-label multiple-dose evaluations for those with RA. Throughout the study, blood tests will be performed to observe the drug's effects and processing by the body. Researchers will carefully watch for any serious side effects related to the study drug from the start until week 33. Participants will be monitored regularly to assess safety and tolerability during the entire study period.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the treatment outcomes of subcutaneous anifrolumab 120 mg once weekly as add-on therapy to antimalarials, with or without glucocorticoids (GCs), in patients with systemic lupus erythematosus (SLE) who have not previously used immunosuppressants or biologics. The study focuses on patients not in Lupus Low Disease Activity State (LLDAS) at enrollment and aims to describe clinical outcomes such as achieving DORIS remission, while also understanding GC tapering and withdrawal possibilities. This is a Phase 3, open-label, single-arm study. Approximately 275 participants aged 18 to 70 will receive anifrolumab subcutaneously once weekly for 52 weeks following a screening period of up to 35 days. Participants may increase their GC dose until week 4 based on investigator recommendation, then those on more than 5 mg/day GC at entry will attempt a taper to 5 mg/day over 12 weeks between weeks 5 and 40. Participants achieving DORIS remission for two visits will then attempt complete GC withdrawal with a 12-week taper. After week 41 until study end, no further GC dose reductions will occur. Following treatment, a 12-week safety follow-up is included for those not continuing anifrolumab. Participants will undergo assessments including clinical evaluations, laboratory tests, and questionnaires to monitor disease activity, remission status, and safety. Researchers will measure attainment of DORIS remission at week 52 as the primary outcome. Study evaluations will include ANA and other antibody testing, infection screening, HPV testing, and adherence to study procedures. The total study duration is approximately 69 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD5492 given by subcutaneous injection in adults with Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies (IIM), or Rheumatoid Arthritis (RA). This is an open-label, multi-center Phase I study designed to investigate these aspects in two parts: single ascending dose and step-up dose administration. The study aims to better understand how AZD5492 behaves and is tolerated in these patients. The study is divided into two parts. Part 1 involves a single ascending dose in adult participants with SLE, with plans to test up to five dose levels and possibly more based on emerging data. After a screening period of up to 42 days, participants receive one dose of AZD5492 and are followed for at least 179 days. Part 2 includes adult participants with SLE (who did not participate in Part 1), IIM, or RA, receiving two doses seven days apart in a step-up dosing design. The first dose is a priming dose, and the second is escalated with at least three target dose levels planned. The study duration is at least 180 days plus screening, with follow-ups possibly extending up to 12 months from study start. Participants attend visits at screening, multiple days within the first month, and at intervals up to day 180 or beyond depending on the part of the study. Safety is monitored by tracking treatment-emergent adverse events, dose limiting toxicities, serious adverse events leading to death, vital sign abnormalities, laboratory test changes, and ECG abnormalities. Researchers assess tolerability and safety throughout the study up to 52 weeks. Pharmacokinetic and pharmacodynamic measurements are also collected to evaluate the effects of AZD5492 in the participants.

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.