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Found 14 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating Risvutatug Rezetecan Ris-Rez, a new medicine targeting specific proteins on cancer cells, in adults with relapsed extensive-stage small cell lung cancer ES-SCLC. This phase 3 study aims to compare how well Ris-Rez works versus the standard treatment, topotecan, by measuring cancer shrinkage, disappearance, and overall survival. The study also monitors safety, side effects, and tolerability of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Both treatments will be administered as part of the study to assess their effects. The study will follow participants for up to approximately 139 weeks to evaluate multiple outcomes including survival, tumor response, disease progression, and brain metastasis control. During the study, participants will have regular evaluations including scans, laboratory tests, vital signs, electrocardiograms, and performance status assessments. Researchers will track adverse events, laboratory changes, and participant experiences with the study drugs. The main outcome measured is overall survival up to about 113 weeks, with additional long-term monitoring of other health and disease measures throughout the study.

Age: 18Years +All GendersPhase 3
126 locations
P

Actively Recruiting

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III study aims to better understand the impact of trontinemab on cognitive decline and daily functioning in this population. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be assigned to receive either intravenous trontinemab or an intravenous placebo. The treatment period lasts up to 72 weeks, during which participants receive infusions as scheduled. Assessments include brain imaging such as amyloid and tau PET scans, cerebrospinal fluid and blood biomarker collection, and cognitive testing. The study also monitors safety through tracking adverse events, infusion-related reactions, and anti-drug antibodies. Participants will attend visits for evaluations including clinical dementia rating, cognitive scales like MMSE and ADAS-Cog-13, and daily living activities assessments. Safety monitoring involves MRI scans and lab tests. The primary outcome measured is the change in Clinical Dementia Rating, Sum of Boxes CDR-SB, from baseline to Week 72. The total duration of participation extends through the 72-week treatment and assessment period, with ongoing safety evaluations.

Age: 50Years - 90YearsAll GendersPhase 3
143 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the immune response, reactogenicity, and safety of a booster dose of the combined reduced-antigen-content diphtheria, tetanus, and acellular pertussis dTpa vaccine in healthy Japanese adolescents aged 11 to under 13 years. This phase 3, non-randomized, single-arm, open-label study aims to assess these effects one month after vaccination in this specific population. Participants aged 11 to less than 13 years receive a single booster dose of the dTpa vaccine on Day 1. The study does not include a comparison group and monitors the response to this single vaccination. The vaccine is administered once, with follow-up assessments planned after vaccination to measure immune markers and safety. Participants will be followed for up to one month after vaccination to assess immunogenicity and safety. Researchers will measure antibody responses against pertussis toxins, diphtheria, and tetanus at baseline and one month post-vaccination. Safety will be monitored through reported local and systemic adverse events up to 7 days post-vaccination and unsolicited adverse events up to 30 days. The study participation lasts approximately one month from vaccination to final safety follow-up.

Age: 11Years - 12YearsAll GendersPhase 3
10 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of a new drug called GSK3862995B in adults with bronchiectasis, a chronic lung disease. This Phase 2 study also examines how the body processes the drug and checks for any immune reactions. Participants will be randomly assigned to receive one of two doses of GSK3862995B or a placebo to compare their effects on bronchiectasis. Participants will receive either Dose Level 1 or Dose Level 2 of GSK3862995B, or a matching placebo. The study uses a double-blind, randomized design, meaning neither participants nor researchers know who gets which treatment. The treatment period lasts up to 48 weeks, during which participants receive repeated doses. The study also includes assessments up to 72 weeks to monitor safety and immune responses. During the trial, participants will undergo evaluations including lung function tests, quality-of-life questionnaires, and monitoring of respiratory symptoms. Researchers will track the number of lung exacerbations, serious adverse events, laboratory tests, vital signs, and electrocardiograms to assess safety and effectiveness. Participants will be involved in regular visits and assessments throughout the treatment and follow-up periods, lasting up to about 72 weeks in total.

Age: 18Years - 85YearsAll GendersPhase 2
134 locations
P

Actively Recruiting

Researchers are evaluating how well mocertatug rezetecan Mo-Rez works compared to standard chemotherapy treatments in women with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. This Phase 3 study also examines the safety and tolerability of Mo-Rez and aims to better understand the main side effects of the drugs. The trial is sponsored by GlaxoSmithKline and involves adult female participants. Participants are randomly assigned to one of two groups one group receives mocertatug rezetecan, and the other receives standard of care chemotherapy with either paclitaxel or doxorubicin, depending on the investigators choice. The study follows a parallel design with single masking. Treatments are given according to the study protocol, and the trial includes up to approximately 97 weeks of follow-up for primary outcomes and up to 156 weeks for secondary outcomes. During the study, participants will have regular assessments including scans reviewed by blinded independent central reviewers, quality of life questionnaires, and monitoring for adverse events through laboratory tests, vital signs, and ECGs. Researchers will measure objective response rates, progression-free survival, overall survival, and other treatment outcomes. The study tracks safety events, antibody responses to Mo-Rez, and changes in participants quality of life over time. Participation may last several years, with ongoing evaluations to monitor health and treatment effects.

Age: 18Years +FEMALEPhase 3
18 locations
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Actively Recruiting

Researchers are evaluating CSL787, an inhaled immunoglobulin G solution, in adults with Non-cystic Fibrosis Bronchiectasis NCFB. This phase 2b, randomized, double-blind, placebo-controlled study aims to explore the effectiveness, safety, and tolerability of two different doses of CSL787 compared to placebo over 6 to 12 months. The main goal is to understand how CSL787 affects the time to first exacerbation and its dose response. Participants will be randomly assigned to receive either a high dose of CSL787, a low dose of CSL787, or a placebo. The treatment is given once daily using a nebulizer device. The study may last from 6 to 12 months depending on the participants course. This trial is conducted at multiple centers and uses a double-blind design to compare the effects of the different treatment groups. During the study, participants will attend regular visits for assessments including lung function tests, monitoring for exacerbations, quality of life questionnaires, and sputum sample collection to check for bacteria. Safety will be monitored by tracking any adverse events throughout the study and for one month after treatment ends. The primary measurement is the time to the first exacerbation, with additional outcomes such as exacerbation rates, symptom improvement, and safety events evaluated over the study period.

Age: 18Years - 85YearsAll GendersPhase 2
13 locations
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Actively Recruiting

Healthy Volunteer

Researchers are developing a new blood test to detect colorectal adenomas and cancer early. Colorectal cancer is a major health concern worldwide, ranking third in diagnosis and second in death rates. Existing screening methods like fecal immunochemical tests can detect cancer but not precancerous lesions called adenomas. This trial focuses on creating a more sensitive and specific non-invasive test by combining advanced machine learning with biological analyses to improve early detection of both adenomas and colorectal cancer.

Age: 18Years +All Genders
6 locations
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Actively Recruiting

Healthy Volunteer

Early-onset colorectal cancer EOCRC, defined as colorectal cancer diagnosed before age 50, is rising sharply among young adults and is a leading cause of cancer-related death in this group. This research aims to develop a non-invasive blood test using microRNA and advanced machine learning to detect EOCRC earlier and more effectively than current screening methods, which are often invasive and have low participation rates in younger populations. The study focuses on analyzing circulating cell-free microRNAs and exosomal microRNAs from blood samples to create a combined diagnostic panel. This approach seeks to improve detection accuracy by leveraging the sensitivity of cell-free microRNAs and the specificity of exosomal microRNAs. The research is conducted in three phases sequencing RNA samples, developing and training detection panels using machine learning, and validating the test in an independent group of participants including EOCRC patients and cancer-free controls. Participants contribute blood samples for molecular testing and data analysis. Researchers will assess the tests sensitivity, specificity, and overall accuracy over approximately one year. The study aims to produce a cost-effective and patient-friendly screening tool that could enhance early detection of EOCRC, improve patient care, and reduce mortality rates.

Age: 18Years - 50YearsAll Genders
13 locations
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Actively Recruiting

Researchers are studying the use of depemokimab as an additional treatment for adults aged 40 to 75 with moderate to severe Chronic Obstructive Pulmonary Disorder COPD who also have type 2 inflammation. The goal is to evaluate the effectiveness and safety of starting depemokimab early alongside the standard care these patients already receive. This study is a Phase 3 trial designed to better understand how depemokimab might help reduce COPD exacerbations in this specific group. Participants will be randomly assigned to receive either depemokimab or a matching placebo, both given in combination with their existing standard treatments for COPD. The treatment period lasts up to 156 weeks about 3 years, during which the study compares the rate of moderate to severe COPD flare-ups between the two groups. This trial uses a parallel design with quadruple masking to maintain objectivity and includes ongoing standard care throughout. Throughout the study, participants will have regular evaluations to monitor their lung function, symptoms, and quality of life using questionnaires like the St. Georges Respiratory Questionnaire and the Evaluating Respiratory Symptoms E-RS for COPD. The main outcome measured is the annual rate of moderate or severe exacerbations over the study period. Safety and response to treatment will be closely observed, with follow-up continuing until the primary completion date in April 2029 and final study completion in June 2029.

Age: 40Years - 75YearsAll GendersPhase 3
121 locations
A

Actively Recruiting

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

All Genders
112 locations

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