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179 Clinical Trials near Chesterfield, MO
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 PowerBortezomib/Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma
Chesterfield, Missouri
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Heart Failure, Others
Must Not Be Taking:Zidovudine, Stavudine
1087 Participants Needed
Hormone Therapy +/− Everolimus for Breast Cancer
Chesterfield, Missouri
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Uncontrolled Diabetes, Others
Must Be Taking:Hormone Therapy
1939 Participants Needed
Pazopanib for Renal Cell Carcinoma
Ballwin, Missouri
This trial is testing whether pazopanib hydrochloride can help prevent the return of kidney cancer in patients who have had surgery to remove it. The medication aims to stop cancer cell growth and block blood flow to tumors. Patients will take the drug for several months and be monitored frequently. Pazopanib has been approved for treating kidney cancer since 2009.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Peptic Ulcer, Heart Failure, Others
Must Not Be Taking:CYP3A4 Inhibitors, QTc Prolonging Drugs
129 Participants Needed
High vs Standard Dose Radiation Therapy for Breast Cancer
Chesterfield, Missouri
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Stage III/IV Cancer, Bilateral Cancer, Others
Must Not Be Taking:Concurrent Chemotherapy
2354 Participants Needed
Chemotherapy + Trastuzumab for Breast Cancer
Chesterfield, Missouri
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Cardiac Disease, Hypertension, Others
Must Not Be Taking:Anthracyclines, Taxanes, Trastuzumab, Others
3270 Participants Needed
Hormone Therapy + Chemotherapy for Breast Cancer
Chesterfield, Missouri
This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Inflammatory Breast Cancer, Metastatic, Others
Must Not Be Taking:Aromatase Inhibitors, SERMs
5018 Participants Needed
Everolimus for Kidney Cancer
Chesterfield, Missouri
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Liver Disease, HIV, Others
Must Not Be Taking:CYP3A4 Inhibitors, CYP3A4 Inducers, Systemic Steroids, Immunosuppressants
1545 Participants Needed
Radiation Therapy + Trastuzumab for Breast Cancer
Chesterfield, Missouri
This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Invasive Breast Cancer, Cardiac Disease, Uncontrolled Hypertension, Pregnancy, Others
Must Not Be Taking:Anthracyclines
2014 Participants Needed
Radiation + Chemotherapy for Small Cell Lung Cancer
Chesterfield, Missouri
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Nursing, Prior Radiotherapy, Others
Must Be Taking:Carboplatin, Cisplatin, Etoposide
731 Participants Needed
Melphalan + Prednisone + Thalidomide/Lenalidomide for Multiple Myeloma
Chesterfield, Missouri
This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Congestive Heart Failure, Angina, Cardiac Arrhythmia, Psychiatric Illness, Others
Must Be Taking:Aspirin, Heparin, Coumadin
306 Participants Needed
Chemotherapy +/− Bevacizumab for Breast Cancer
Chesterfield, Missouri
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HER2+ Cancer, Cardiovascular Disease, Others
Must Not Be Taking:Anthracyclines, Anthracenediones, Taxanes
4994 Participants Needed
Hormone Therapy + Chemotherapy for Breast Cancer
Chesterfield, Missouri
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Chronic Obstructive Pulmonary Disease, Others
Must Be Taking:Hormone Therapy
10273 Participants Needed
Chemotherapy +/− Bevacizumab for Stage II Colon Cancer
Chesterfield, Missouri
This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Disease, Hypertension, Heart Failure, Others
2431 Participants Needed
Chemotherapy + Monoclonal Antibody Therapy for Non-Hodgkin's Lymphoma
Chesterfield, Missouri
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Involvement, Cardiac Disease, HIV, Others
Must Not Be Taking:Monoclonal Antibodies
571 Participants Needed
High-Dose Interferon Alfa for Melanoma
Chesterfield, Missouri
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.
PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Autoimmune Disorders, Heart Disease, Others
Must Not Be Taking:Chemotherapy, Immunotherapy, Corticosteroids, Others
1150 Participants Needed
Glofitamab + Pola-R-CHP for B-Cell Lymphoma
Chesterfield, Missouri
The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Organ Transplant, Indolent Lymphoma, CNS Disease, Others
Must Not Be Taking:Immunosuppressants, Monoclonal Antibodies
1130 Participants Needed
CagriSema for Obesity
Saint Peters, Missouri
This trial tests how well different treatments help people with excess body weight lose weight. Participants will receive one of four treatments through regular injections. The study will last over a year, followed by a period to observe long-term effects.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Others
3400 Participants Needed
Atogepant for Migraine Prevention
Saint Peters, Missouri
This trial is testing a medication called Atogepant to see if it can safely and effectively prevent migraines in people who have them often. The medication works by blocking signals in the brain that cause migraines. Atogepant is a newly approved oral medication for the prevention of episodic migraine.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hypertension, Suicidal Ideation, ECG Abnormalities, Others
596 Participants Needed
PDS Implant with Ranibizumab for Age-Related Macular Degeneration
Chesterfield, Missouri
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Ocular Diseases, Uncontrolled Hypertension, Others
Must Be Taking:Anti-VEGF Injections
1000 Participants Needed
Ibrutinib + Rituximab for Follicular Lymphoma
Chesterfield, Missouri
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Transformed Lymphoma, Prior Treatment, CNS Lymphoma, Cardiovascular Disease, Others
445 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"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 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 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'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
Tranexamic Acid for ACL Surgery
Chesterfield, Missouri
This is a prospective, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in improving postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using patellar tendon autograft in adolescent and young adult patients.
A total of 100 patients, aged 14 to 22 years and undergoing eligible ACLR, will be enrolled across multiple participating sites. Eligible participants will be randomized 1:1 to receive either oral TXA (1.95 g per day, divided into three 650 mg capsules) or placebo (microcrystalline cellulose) once daily from postoperative day 1 to 10, in addition to standard intraoperative care. All participants will receive 1 g IV TXA prior to incision and 1 g IV TXA at closure, per standard surgical protocol.
The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents. Participants will be followed through routine postoperative visits at the participating institutions out to one year with a phone call for patient reported outcomes at 2 years.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:14 - 22
Key Eligibility Criteria
Disqualifiers:Revision ACLR, DVT History, Others
Must Not Be Taking:Hormonal Contraception
100 Participants Needed
iFuse TORQ for Sacroiliac Joint Dysfunction
Chesterfield, Missouri
This trial is testing a new device called iFuse TORQ that helps join bones in the lower back. It aims to help patients with lower back pain or instability by stabilizing and fusing their sacroiliac joint. The iFuse Implant System® has been used in minimally invasive sacroiliac joint fusion to relieve pain and improve quality of life in patients with sacroiliac joint degeneration or disruption.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:21+
Key Eligibility Criteria
Disqualifiers:Severe Back Pain, Sacroiliac Pathology, Osteoporosis, Rheumatologic Condition, Fibromyalgia, Others
110 Participants Needed
Tirzepatide for Type 2 Diabetes
Saint Peters, Missouri
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pancreatitis, CVD, Others
Must Be Taking:Metformin
780 Participants Needed
Fluocinolone Acetonide Implant for Posterior Uveitis
Chesterfield, Missouri
A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Diabetes, Glaucoma, Ocular Infections, Others
Must Not Be Taking:Steroids, Immunosuppressives
125 Participants Needed
Rimegepant for Migraine Prevention
Saint Peters, Missouri
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cluster Headaches, Basilar Migraine, Chronic Pain, Others
658 Participants Needed
Rimegepant for Migraine
Saint Peters, Missouri
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cluster Headache, Chronic Pain, Others
Must Not Be Taking:Triptans, CGRP Antagonists
633 Participants Needed
LTI-03 for Pulmonary Fibrosis
Chesterfield, Missouri
Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring.
The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate.
Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period.
Study Assessments: Up to 9 visits to the study clinic will be required.
Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler.
Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only.
Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis.
Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:40+
Key Eligibility Criteria
Disqualifiers:Active Smoker, Renal Impairment, Hepatic Impairment, Others
Must Be Taking:Nintedanib, Pirfenidone, Nerandomilast
120 Participants Needed
NANOVAE for Knee Osteoarthritis
Chesterfield, Missouri
The below summarizes relevant information for investigator(s) to consider the use of Allogenic Human Amniotic Fluid product in a clinical protocol detailing study design and conduct for a phase I/II randomized, double-blinded, placebo-controlled clinical trial to evaluate the safety and potential efficacy of NANOVAE injected intra-articularly in patients suffering from knee osteoarthritis. The IB will be reviewed annually and amended when further information becomes available.
Osteoarthritis (OA) is a degenerative disease of the joints that affects millions of people worldwide, yet its exact causes are not fully understood. Middle-aged to elderly individuals are often the most impacted by OA, which primarily affects the knee, hip, spine, and joints in the fingers. Among these, knee osteoarthritis (KOA) is the most common form, causing pain, stiffness, and reduced functionality, and it is a major contributor to chronic bone and muscle pain. It is also a leading cause of disability in adults who are not living in institutions. Treatment for KOA is challenging due to its resistance to medications, procedures, and surgeries. The primary objective is to alleviate pain and enhance overall function. However, since there is currently no cure for OA, the need for an effective therapy remains urgent. Healthcare professionals often encounter patients whose pain may result from an inflammatory response triggered by injury or disease. Research suggests that regenerative medicine, utilizing techniques like stem cells, platelet-rich plasma (PRP), amniotic fluid, and cytokine modulation, holds promise for treating KOA.
OA is associated with an increase in pro-inflammatory substances such as interleukin (IL)-1, IL-6, tumor necrosis factor-alpha (TNF-α), matrix metalloproteinases (MMPs), nitric oxide (NO), reactive oxygen species (ROS), and cytokine-inducible cyclooxygenase-2 (COX-2). These inflammatory agents affect various cell types within the affected joints, including chondrocytes, osteoblasts, osteoclasts, synoviocytes, and macrophages. Some miRNAs, which are downregulated in OA, have been identified as protective factors. For example, miR-130 helps regulate TNF-α levels, while miR-149 controls several inflammatory cytokines such as IL-1, IL-6, and TNF-α. The breakdown of the cartilage matrix is a key characteristic of OA. MMP-13, a member of the MMP family, plays a significant role in degrading the collagen network during OA development. Several miRNAs, including miR-27b, miR-27a, miR-148a, miR-320, miR-127-5p, and miR-411, are downregulated in OA and target the mRNA of this proteinase. It is important to note that a single miRNA can regulate multiple target genes associated with OA progression. For instance, miR-105 and miR-148, both downregulated in OA, target genes such as Runx2, ADAMTS4, ADAMTS5, ADAMTS7, ADAMTS12, MMP-13, and COL10, implying their potential protective roles.
Several studies have shown a link between certain miRNAs, aging, and the progression of OA. For example, miR-320c is downregulated in aging OA samples and regulates ADAMTS5, suggesting that this miRNA may serve as a protective factor by enhancing chondrogenesis.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:21 - 75
Key Eligibility Criteria
Disqualifiers:Cardiac Dysfunction, Diabetes, Autoimmune Disorders, Liver Dysfunction, Others
Must Not Be Taking:Anticoagulants, Immunosuppressives, Systemic Steroids
24 Participants Needed
GSK4527226 for Early Alzheimer's Disease
Chesterfield, Missouri
The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Stroke, CNS Trauma, Alcohol Use, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Opiates, Others
367 Participants Needed
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