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Found 7 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.
Actively Recruiting
Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.
Actively Recruiting
Researchers are evaluating the effectiveness of apremilast compared with a placebo in treating juvenile psoriatic arthritis (JPsA) in children aged 5 to less than 18 years. This phase 3, multicenter, double-blind, randomized, placebo-controlled study aims to assess the safety, efficacy, and drug behavior in pediatric participants with active JPsA, a condition involving arthritis and psoriasis or related symptoms. Participants will be randomly assigned to receive either oral apremilast or a matching oral placebo. The study will monitor the response to treatment over a 16-week period, focusing on achieving a specific improvement based on American College of Rheumatology Pediatric (ACR Pedi 30) criteria. Both treatments will be administered during this time to compare their effects. During the study, children will be regularly assessed for joint activity and disease symptoms. Researchers will measure the number of participants achieving the ACR Pedi 30 response by week 16 to evaluate treatment effectiveness. Safety and pharmacokinetics will also be monitored throughout, with the total participation duration covering the initial 16 weeks of treatment observation.
Actively Recruiting
Researchers are evaluating the effectiveness of Ofatumumab treatment in patients with relapsing multiple sclerosis (RMS) in Portugal. The study compares patients who started Ofatumumab within three years of their RMS diagnosis to those who began treatment more than three years after diagnosis. This observational study reflects real-world medical care and aims to understand how timing of treatment initiation might impact disease activity. The study includes two groups of patients based on when they started Ofatumumab: early initiators and later initiators. Ofatumumab is prescribed by physicians according to local guidelines, and no medication is provided by the study sponsor. Data will be collected during three visits over a maximum of 24 months. If a patient's disability worsens at the 12- or 24-month visits, an additional follow-up visit will be conducted 6 plus or minus 1 month later to confirm this change. Participants will undergo assessments including patient-reported outcome questionnaires and disability status evaluations. The main outcome measured is the proportion of patients showing no evidence of disease activity (NEDA-3) from month 12 to month 24. The study requires patients to have been treated with Ofatumumab for at least two years. The total participation period may extend up to 24 months, with additional visits if disability progression is suspected.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of FBL-MTX, a folate-based liposome encapsulating methotrexate, administered by subcutaneous injection in patients with moderate-to-severe active Rheumatoid Arthritis (RA). This Phase IIa proof-of-concept study aims to explore if this method provides a patient-friendly treatment with at least the same efficacy as existing options, focusing on patients who are either new to disease-modifying antirheumatic drugs (DMARD-nave) or who have not responded well or tolerated oral methotrexate. During the treatment period, participants will attend eight study visits every two weeks. DMARD-nave patients will start with a 1 mg dose of FBL-MTX subcutaneously, with doses adjusted based on clinical response every four weeks, up to a maximum of 2.5 mg every two weeks. Patients with inadequate response or intolerance to oral methotrexate will begin with a 2.5 mg dose, also titrated as needed. This dose-titration follows a treat-to-target strategy to optimize treatment. Participants will be monitored from screening through week 14, with evaluations of disease activity using measures like DAS28-CRP, Clinical Disease Activity Index, and Health Assessment Questionnaires at multiple time points. Researchers will assess how many reach remission or low disease activity, and track responses according to American College of Rheumatology criteria. Safety, tolerability, and quality of life assessments will also be part of the study to understand the overall impact of FBL-MTX treatment over the 14-week period.
Actively Recruiting
Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.