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180 Clinical Trials near Dunedin, FL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerInhaled Treprostinil for Idiopathic Pulmonary Fibrosis
Clearwater, Florida
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Obstructive Airway, Cardiac Disease, Others
Must Be Taking:Pirfenidone, Nintedanib
576 Participants Needed
Non-TNFi Biologics vs Targeted Synthetic DMARDs for Rheumatoid Arthritis
Clearwater, Florida
This trial is testing advanced medications for RA patients who haven't responded to standard treatments. It compares biologic drugs that target immune proteins and synthetic drugs that block harmful molecules in immune cells. The goal is to see which treatment improves patients' quality of life and daily functioning better. Biologic therapies have notably improved the treatment of RA, making disease remission a realistic goal.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Heart Failure, Hepatitis, Others
Must Be Taking:TNFi-biologic
924 Participants Needed
Vagus Nerve Stimulation for Rheumatoid Arthritis
Clearwater, Florida
The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:22 - 75
Key Eligibility Criteria
Disqualifiers:Psychiatric Illness, Cardiovascular Disease, Neurological Syndromes, Others
Must Be Taking:Conventional DMARDs
243 Participants Needed
T-DM1 + Tucatinib for Breast Cancer
Safety Harbor, Florida
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Cancer, Hepatitis B/C, Others
Must Be Taking:Taxane, Trastuzumab
1056 Participants Needed
Tildrakizumab for Psoriatic Arthritis
Clearwater, Florida
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Hepatitis B/C, HIV, Others
Must Be Taking:Anti-TNF Agents
510 Participants Needed
Tildrakizumab for Psoriatic Arthritis
Clearwater, Florida
This trial is testing tildrakizumab, a medication that reduces inflammation, in patients with active Psoriatic Arthritis who haven't tried certain other treatments. It works by blocking a protein to help manage symptoms. Tildrakizumab is approved for treating moderate to severe plaque psoriasis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Uncontrolled Disease, Active Malignancy, Recent Heart Issues, Others
296 Participants Needed
Duloxetine for Colorectal Cancer
Safety Harbor, Florida
This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:25+
Key Eligibility Criteria
Disqualifiers:Peripheral Neuropathy, Seizure Disorder, Glaucoma, Others
Must Be Taking:Oxaliplatin
220 Participants Needed
Tildrakizumab for Pediatric Psoriasis
Clearwater, Florida
This trial involves studying how a drug moves through and is processed by the bodies of children. It first examines older children and then younger children. The goal is to understand how the drug is absorbed, distributed, metabolized, and excreted in these age groups.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:6+
Key Eligibility Criteria
Disqualifiers:Non-plaque Psoriasis, Lab Abnormalities, Infections, HIV, Others
130 Participants Needed
Cell Therapy for Heart Failure
Clearwater, Florida
This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:21 - 90
Key Eligibility Criteria
Disqualifiers:Other Cardiac, Vascular, Others
125 Participants Needed
Olpasiran for Cardiovascular Disease
Clearwater, Florida
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Prior Atherothrombotic Event, Revascularization, Bleeding Disorder
11000 Participants Needed
VK2735 for Weight Loss
Clearwater, Florida
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Thyroid Carcinoma, Pancreatitis, Others
Must Not Be Taking:Glucose-lowering Agents
4500 Participants Needed
VK2735 for Weight Loss in Type 2 Diabetes
Clearwater, Florida
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Severe Hypoglycemia, Others
Must Be Taking:Oral Glycemic-lowering
1100 Participants Needed
Weekly vs Daily Insulin for Type 1 Diabetes
Palm Harbor, Florida
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypoglycaemic Unawareness, Others
Must Be Taking:Insulin
877 Participants Needed
IMVT-1402 for Myasthenia Gravis
Clearwater, Florida
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Myasthenic Crisis, Thymectomy, Malignant Thymoma, Others
231 Participants Needed
AZD0780 for Cardiovascular Disease
Palm Harbor, Florida
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Homozygous Familial Hypercholesterolaemia, Revascularisation Planned, Others
Must Be Taking:Statins
15100 Participants Needed
Tezepelumab for COPD
Clearwater, Florida
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Asthma, Tuberculosis, Malignancies, Others
Must Be Taking:ICS, LABA, LAMA
990 Participants Needed
HER2-Targeted Therapy for Breast Cancer
Clearwater, Florida
This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Cancer, Inadequate Cardiac Function, Others
Must Be Taking:HER2-targeted Therapy
1524 Participants Needed
BI 1291583 for Bronchiectasis
Clearwater, Florida
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.
Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Aspergillosis, Tuberculosis, Malignancy, Others
Must Not Be Taking:DPP1 Inhibitors
1755 Participants Needed
Rilvegostomig or Pembrolizumab for Non-Small Cell Lung Cancer
Clearwater, Florida
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Organ Transplant, Autoimmune Disorders, Others
Must Not Be Taking:Steroids, Anticonvulsants, Immunosuppressives, Others
830 Participants Needed
RO7790121 for Crohn's Disease
Clearwater, Florida
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Bowel, Pregnancy, Infections, Others
Must Not Be Taking:Anti-TL1A Therapy
600 Participants Needed
Why Other Patients Applied
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Icotrokinra for Psoriatic Arthritis
Clearwater, Florida
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Organ Disease, Malignancy, Others
Must Be Taking:Biologics
750 Participants Needed
Dazodalibep for Sjögren's Syndrome
Clearwater, Florida
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Pregnancy, Others
Must Not Be Taking:Antibiotics, Antivirals
844 Participants Needed
Nipocalimab for Sjogren's Syndrome
Clearwater, Florida
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Autoimmune, Cardiovascular, Hepatic, Others
600 Participants Needed
Omecamtiv Mecarbil for Heart Failure
Clearwater, Florida
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Acute Coronary Syndrome, Dialysis, Others
Must Be Taking:Loop Diuretics
1800 Participants Needed
PCV21 Vaccine for Pneumonia
Clearwater, Florida
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.
There will be 6 study visits:
-Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Seizure, Bleeding Disorder, Others
Must Not Be Taking:Immunosuppressants, Anticoagulants
1630 Participants Needed
Ibuzatrelvir for Coronavirus
Clearwater, Florida
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Severe Renal Impairment, Active Liver Disease, Others
Must Not Be Taking:Antivirals, COVID-19 MAbs
2330 Participants Needed
Sonelokimab for Psoriatic Arthritis
Clearwater, Florida
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Inflammatory Conditions, IBD, Others
Must Be Taking:TNFα Inhibitors
600 Participants Needed
Sonelokimab for Psoriatic Arthritis
Clearwater, Florida
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Disease, Arthritis Mutilans, Others
Must Not Be Taking:Biologics
960 Participants Needed
Bimekizumab for Psoriatic Arthritis
Clearwater, Florida
The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Tuberculosis, Rheumatoid Arthritis, Others
Must Be Taking:CsDMARDs
684 Participants Needed
Dapirolizumab Pegol for Lupus
Clearwater, Florida
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16+
Key Eligibility Criteria
Disqualifiers:HIV, Malignancy, Heart Disease, Others
Must Be Taking:Antimalarials, Corticosteroids, Immunosuppressants
450 Participants Needed
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