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Found 7 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Age: 18Years +All GendersPhase 3
174 locations
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Actively Recruiting

Researchers are studying influenza in children younger than 12 years to understand how the virus changes when treated with the drug baloxavir marboxil. This study has two parts Part A monitors the presence and development of specific changes in the virus before and after treatment in pediatric patients. Part B focuses on how influenza spreads within households from treated children under 12 to their family members, though no new participants will join Part B as per the latest study update. Participants receive a single oral dose of baloxavir marboxil on the first day, with the dose based on their body weight and age. Household contacts of the treated children are enrolled for observation but do not receive the drug. The study tracks viral changes and resistance at multiple points, including baseline and several days after treatment, and monitors influenza transmission within households. Throughout the study, children will undergo various tests such as local influenza and SARS-CoV-2 testing to confirm infection status. Researchers will measure how often virus mutations associated with resistance occur, changes in viral levels, and any side effects up to 29 days. For household contacts, influenza transmission and symptom development are checked on days 6 and 10. Participation involves scheduled visits and testing to gather this information, with the study expected to continue until mid-2027.

Age: 3Weeks - 11YearsAll GendersPhase 3
51 locations
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Actively Recruiting

Healthy Volunteer

Researchers are examining how two osteopathic techniques, Fourth Ventricle Compression CV4 and Rib Raising RR, affect the autonomic nervous system ANS activity in healthy adults. The study involves about 109 participants and aims to measure changes in heart rate variability HRV to assess ANS function. This research focuses on understanding the impact of these manual therapies on nervous system balance and activity. Participants will be randomly assigned to one of three groups. One group will receive three 30-minute sessions combining CV4 and RR techniques once a week for three weeks. Another group will have three 30-minute sessions of CV4 alone on the same schedule. The placebo group will undergo a sham procedure using an ultrasound transducer for three 30-minute sessions weekly, without therapeutic effect. During the study, researchers will measure HRV and related parameters using specialized monitoring equipment before treatment, immediately after the last session, and one month later. Measurements will be taken while participants are seated and last five minutes each time. This setup will help evaluate changes in heart rhythm and autonomic nervous system function over time. The total participation period includes treatment and follow-up measurements to monitor lasting effects.

Age: 20Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.

Age: 18Years - 74YearsAll GendersPhase 2
121 locations
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Actively Recruiting

Researchers are evaluating sonelokimab in adults with active psoriatic arthritis who have not had adequate results or could not tolerate prior anti-tumor necrosis factor TNF alpha therapy. This Phase 3, multicenter, randomized, double-blind study compares the safety and effectiveness of two doses of sonelokimab against placebo and an active reference treatment called risankizumab. Participants are randomly assigned to one of four groups one receiving sonelokimab dose 1, another receiving sonelokimab dose 2, one receiving placebo, and one receiving risankizumab. Those in the sonelokimab groups receive four initial subcutaneous doses as induction, then maintenance doses every four weeks starting at Week 8. The placebo and risankizumab groups receive their respective treatments subcutaneously according to the study protocol. During the study, participants will undergo assessments of joint tenderness and swelling, skin psoriasis activity, physical function, and quality of life at Week 16. Researchers will monitor response rates based on improvement criteria such as the American College of Rheumatology 50% improvement ACR50. Safety and tolerability will also be followed throughout the trial, which is expected to complete by January 2027.

Age: 18Years +All GendersPhase 3
142 locations
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Actively Recruiting

Researchers are evaluating the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma PDAC, the most common type of pancreatic cancer. This observational study focuses on adult patients who show symptoms suggesting pancreatic cancer or who are scheduled for procedures involving pancreatic cancer assessment. Panuri is a laboratory test designed to detect enzyme activity in urine samples related to PDAC, intended to support doctors in deciding if further imaging tests are needed. Participants will provide urine samples for the Panuri test during the study. The study includes two groups one with patients showing symptoms of pancreatic cancer and another with patients scheduled for pancreatic tissue assessment due to cancer suspicion. The test results will be kept blinded from both participants and physicians. Diagnosis confirmation will be done through review of electronic health records. Participants will be monitored from enrollment up to six months to assess how well the Panuri test detects PDAC. Data such as urine samples and medical records will be collected, but no treatment or intervention will be given as part of the study. The study aims to provide important information to help improve the diagnosis process for pancreatic cancer.

Age: 18Years +All Genders
32 locations
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Actively Recruiting

Researchers are studying bronchiectasis in adults and adolescents aged 12 to under 18 who produce sputum and have experienced flare-ups. The trial aims to evaluate whether the medicine BI 1291583 can help reduce these flare-ups compared to a placebo. Participants are randomly assigned to receive either BI 1291583 or a placebo in a phase III, double-blind study. Participants take one tablet of either BI 1291583 or placebo once daily for up to 1 year and 6 months. The study includes two groups one receiving the active medication and the other receiving placebo tablets that look identical but contain no medicine. The study period lasts up to 1 year and 8 months, during which participants attend up to 10 site visits and receive about 13 phone calls. During the study, participants regularly record their bronchiectasis symptoms in a smartphone diary. Study doctors monitor participants health, note any flare-ups, and check for unwanted effects. Researchers compare the number of flare-ups between the two groups as the primary measure. Secondary measures include time to first flare-up, quality of life changes, lung function changes, and rates of severe flare-ups.

Age: 12Years +All GendersPhase 3
470 locations