Clearwater

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are conducting a Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DB-2304 in healthy adults and participants with Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus (CLE). The study aims to understand the effects of DB-2304 injection in these groups by comparing it to placebo and monitoring participants receiving standard treatments like prednisone. Participants include healthy adults aged 18 to 55 and SLE/CLE patients aged 18 to 70 with active disease despite treatment. The study includes two parts. Part A involves healthy participants aged 18 to 55 receiving DB-2304 or placebo, while Part B involves SLE/CLE participants aged 18 to 70 receiving DB-2304, placebo, or prednisone alongside their stable treatment regimen. Treatments are given by injection, and participants are monitored for adverse events and other health parameters over specific timeframes. Part A participants are followed for up to 112 days after their last dose, and Part B participants for up to 196 days. During the study, participants undergo physical exams, vital sign checks, ECGs, laboratory tests, and weight and heart rate measurements. Researchers closely track any treatment-emergent or serious adverse events and monitor respiratory rate and body temperature. Participants must comply with study protocols and contraception requirements if applicable. The study assesses safety and tolerability as primary outcomes, with ongoing monitoring throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

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 evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.