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201 Clinical Trials near Aurora, CO
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 PowerPitolisant for Prader-Willi Syndrome
Aurora, Colorado
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.
Secondary objectives include assessing the impact of pitolisant on:
Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6+
Key Eligibility Criteria
Disqualifiers:Sleep Apnea, Hypersomnia, Others
134 Participants Needed
BHV-7000 for Epilepsy
Aurora, Colorado
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
Retatrutide vs Semaglutide for Type 2 Diabetes
Aurora, Colorado
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Severe Hypoglycemia, Obesity Surgery, Others
Must Be Taking:Metformin, SGLT2i
1250 Participants Needed
Dazodalibep for Sjögren's Syndrome
Denver, Colorado
Primary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Secondary Objectives:
1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Thrombosis, Polymyositis, Malignancy, Pregnancy, Others
435 Participants Needed
Sotagliflozin for Diabetic Kidney Disease
Aurora, Colorado
Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, DKA History, Others
Must Be Taking:Insulin, RASB
150 Participants Needed
Dinutuximab + Chemotherapy for High-Risk Neuroblastoma
Aurora, Colorado
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs 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. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 30
Key Eligibility Criteria
Disqualifiers:Bone Marrow Failure, Primary Immunodeficiency, Pregnancy, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
478 Participants Needed
Vagus Nerve Stimulation for PWS
Aurora, Colorado
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 40
Key Eligibility Criteria
Disqualifiers:Pregnancy, Serious Mental Illness, Cardiac Disease, Epilepsy, Others
102 Participants Needed
Ianalumab for Lupus
Aurora, Colorado
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Infections, Live Vaccines, Pregnancy, Others
550 Participants Needed
BHV-7000 for Epilepsy
Aurora, Colorado
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:366 - 46
Key Eligibility Criteria
Disqualifiers:Chronic Myeloid Leukemia, Down Syndrome, Others
Must Be Taking:Tyrosine Kinase Inhibitors
222 Participants Needed
AMX0035 for Progressive Supranuclear Palsy
Aurora, Colorado
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Schizophrenia, Bipolar, Depression, Others
110 Participants Needed
IMC-F106C vs Nivolumab for Melanoma
Aurora, Colorado
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Cancers, CNS Metastases, Others
Must Not Be Taking:Immunosuppressants
680 Participants Needed
Dazodalibep for Sjögren's Syndrome
Denver, Colorado
This trial is testing dazodalibep, a medication, to see if it can help people with moderate-to-severe Sjögren's Syndrome. The goal is to reduce their symptoms and improve their quality of life. Researchers will also check if the medication is safe and well-tolerated by patients.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Cardiovascular, HIV, Others
Must Not Be Taking:Biologics, B-cell Therapies
651 Participants Needed
Nectero EAST System for Abdominal Aortic Aneurysm
Aurora, Colorado
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:21 - 85
Key Eligibility Criteria
Disqualifiers:Cardiac Conditions, Recent Surgery, Stroke, Others
400 Participants Needed
Darovasertib + Crizotinib for Uveal Melanoma
Aurora, Colorado
This trial is testing a new drug combination (IDE196 and crizotinib) on patients with a specific type of eye cancer that has spread. The goal is to see if this combination can stop or slow down the cancer better than other treatments. Crizotinib has been used in treating various cancers with ALK gene rearrangements, showing high response rates.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Concurrent Malignant Disease, CNS Metastases, AIDS, Others
Must Not Be Taking:PKC Inhibitors, MET Inhibitors
420 Participants Needed
Amino Acids for Fatty Liver Disease
Aurora, Colorado
Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:13 - 18
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Anemia, Others
Must Not Be Taking:Metformin, Glucocorticoids, Antipsychotics, Others
55 Participants Needed
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Uncontrolled Diabetes, Others
Must Not Be Taking:Anti-PD-1, Anti-PD-L1
2400 Participants Needed
Udenafil for Single Ventricle Heart Disease
Denver, Colorado
This trial tests udenafil, a medication that improves blood flow, on adolescents who have had heart surgery (Fontan procedure). It works by relaxing blood vessels to help them exercise better.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Heart Failure, Liver Cirrhosis, Others
Must Be Taking:Antiplatelet, Anticoagulant
436 Participants Needed
Gene Therapy for Rett Syndrome
Aurora, Colorado
This trial tests NGN-401, a gene therapy using a virus to deliver a healthy gene, in female children with Rett syndrome. It aims to improve brain cell function by providing the correct version of a missing or faulty gene.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:3 - 10
Sex:Female
Key Eligibility Criteria
Disqualifiers:Normal Hand Function, Other Conditions, Others
Must Be Taking:Anti-epileptics
33 Participants Needed
Orforglipron for Obesity
Aurora, Colorado
This trial will test the safety and effectiveness of an oral medication called orforglipron in adults who are obese or overweight and have related health problems. The medication aims to help reduce body weight by possibly affecting appetite or metabolism.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Thyroid Cancer, Others
3127 Participants Needed
Why Other Patients Applied
"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
"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
"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 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'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
Smartwatch-Guided DOAC Therapy for Atrial Fibrillation
Aurora, Colorado
This trial tests whether taking blood-thinning medication continuously or only when a smart watch detects an irregular heartbeat is better for adults with a history of irregular heartbeats and moderate stroke risk.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:22 - 85
Key Eligibility Criteria
Disqualifiers:Valvular AF, Pregnancy, Hypertrophic Cardiomyopathy, Others
Must Be Taking:DOACs
5350 Participants Needed
Semaglutide for Polycystic Ovary Syndrome
Aurora, Colorado
This trial involves girls and women aged 12-35 with obesity and PCOS taking a medication that helps manage blood sugar and promote weight loss. The goal is to see if this treatment can improve their weight and reproductive health.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:Thyroid Cancer, Diabetes, Pregnancy, Others
Must Be Taking:Metformin
80 Participants Needed
Semaglutide for Type 1 Diabetes
Aurora, Colorado
This trial is testing semaglutide, a drug that helps with heart, kidney, and blood sugar health, in adults with type 1 diabetes. The drug has shown benefits for people with type 2 diabetes, but it is not yet approved for type 1 diabetes. Researchers want to see if it can provide similar health improvements for this new group. Semaglutide has been evaluated in numerous trials for its effectiveness in improving blood sugar levels and weight loss in type 2 diabetes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 49
Key Eligibility Criteria
Disqualifiers:Thyroid Disease, Hypertension, Cancer, Others
Must Be Taking:Insulin
60 Participants Needed
Orforglipron for Type 2 Diabetes and Obesity
Aurora, Colorado
This trial is testing a new diabetes medication called orforglipron to see if it is safer and more effective than insulin in people with type 2 diabetes who are overweight or obese and at higher risk for heart problems. The study will last several years and involve multiple visits.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pancreatitis, Others
Must Be Taking:Oral Antihyperglycemics
2749 Participants Needed
Varenicline + PSF-M for Smoking Cessation in HIV/AIDS
Aurora, Colorado
This trial tests a mobile app and a medication to help people with HIV quit smoking. The app provides tips and support, while the medication reduces cravings. The study aims to see if this combination is more effective than standard care.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Liver Failure, Others
Must Be Taking:Varenicline
400 Participants Needed
Ribitol for Limb-Girdle Muscular Dystrophy
Aurora, Colorado
This trial will test the safety and effectiveness of BBP-418 in patients aged 12 to 60 who have a specific type of muscular dystrophy called LGMD2I/R9. The goal is to see if this new treatment can help improve their condition over several months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 60
Key Eligibility Criteria
Disqualifiers:Renal Impairment, Pregnancy, Suicidal Ideation, Others
Must Not Be Taking:Ribose, Sugar Alcohols, Corticosteroids, Others
81 Participants Needed
Iptacopan for Membranoproliferative Glomerulonephritis
Aurora, Colorado
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 60
Key Eligibility Criteria
Disqualifiers:Transplantation, Chronic Infections, Autoimmune Diseases, Others
Must Be Taking:RAS Inhibitors
106 Participants Needed
ABC008 for Inclusion Body Myositis
Aurora, Colorado
This trial is testing a new drug called ABC008 to help people with Inclusion Body Myositis, a muscle disease with few treatment options. The drug may work by affecting certain immune cells. Researchers will check if it improves muscle strength and quality of life.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Other Myositis, Autoimmune Diseases, Others
231 Participants Needed
ADI-PEG 20 + Chemotherapy for Leiomyosarcoma
Aurora, Colorado
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Uncontrolled Illness, HIV, Others
Must Not Be Taking:Antiretrovirals, Immunosuppressants
300 Participants Needed
RGX-202 Gene Therapy for Duchenne Muscular Dystrophy
Aurora, Colorado
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
This is a multicenter, open-label dose evaluation clinical study to assess the safety, tolerability, and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in participants with Duchenne.
For additional information on how to participate (or be considered for the study), please follow this link: https://mytomorro.ws/affinity-ct-gov
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:1 - 11
Sex:Male
Key Eligibility Criteria
Disqualifiers:Gene Therapy, Cardiac Dysfunction, Others
Must Be Taking:Systemic Glucocorticoids
65 Participants Needed
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