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203 Clinical Trials near Camarillo, CA
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 PowerTirzepatide for Obesity
Oxnard, California
This trial is testing tirzepatide, a medication that helps control blood sugar and reduce appetite, to see if it can lower health problems and death rates in adults who are very overweight. Tirzepatide was developed by Eli Lilly to improve blood sugar control in adults with type 2 diabetes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Diabetes, Recent MI, Pancreatitis, Others
15374 Participants Needed
Amlitelimab for Eczema
Oxnard, California
This trial is testing amlitelimab, a medication for adults with moderate to severe atopic dermatitis who were in a previous trial. The study aims to see if the medication is safe and effective over an extended time. Amlitelimab works by calming the immune system to reduce skin inflammation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Immunosuppression, Transplant History, Malignancies, TB, Others
1663 Participants Needed
CSL300 for Kidney Failure
Oxnard, California
This trial is testing CSL300, a new treatment, to see if it helps people with heart disease or diabetes who are on dialysis. The study aims to find the right dose and check if it improves heart health by reducing inflammation.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Abnormal LFTs, Life-threatening Disease, Others
Must Not Be Taking:Immunosuppressants
2310 Participants Needed
XEN45 Gel Stent for Open-Angle Glaucoma
Ventura, California
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed.
XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States.
All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months.
Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:45+
Key Eligibility Criteria
Disqualifiers:Unhealthy Conjunctiva, Excessive Bleeding, Others
65 Participants Needed
RGX-314 Gene Therapy for Age-Related Macular Degeneration
Oxnard, California
This trial is testing a new one-time gene therapy called RGX-314 for patients with wet AMD. The goal is to reduce the need for regular treatments by helping the eye produce its own protective proteins. This could make treatment easier and more effective for patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 89
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Advanced Glaucoma, Others
Must Be Taking:Anti-VEGF
660 Participants Needed
Sacituzumab Govitecan + Pembrolizumab for Triple-Negative Breast Cancer
Westlake Village, California
This trial compares the effectiveness of a combination of two drugs, SG and pembrolizumab, in patients with advanced triple-negative breast cancer. SG targets and kills cancer cells with chemotherapy, while pembrolizumab helps the immune system attack the cancer. Pembrolizumab has been shown to improve survival in various cancers, including triple-negative breast cancer, when used alone or in combination with other treatments.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors
443 Participants Needed
RTX-GRT7039 Injections for Knee Osteoarthritis
Thousand Oaks, California
This trial uses knee injections called RTX-GRT7039 for patients with knee osteoarthritis who still have pain despite usual treatments. The injections aim to reduce knee pain, possibly by affecting pain pathways or inflammation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Joint Replacement, Significant Trauma, Hip Osteoarthritis, Others
930 Participants Needed
Telitacicept for Lupus
Thousand Oaks, California
This trial is testing telitacicept, a protein that helps reduce overactive immune cells, in patients with active lupus who don't respond well to standard treatments. It works by blocking proteins that help immune cells grow, which can reduce lupus symptoms. Telitacicept is a new treatment that has been approved in China for adults with active lupus.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 70
Key Eligibility Criteria
Disqualifiers:Lupus Nephritis, Neuropsychiatric SLE, Others
Must Be Taking:Corticosteroids, Antimalarials, Immunosuppressives
350 Participants Needed
mRNA-1345 Vaccine for Respiratory Syncytial Virus
Oxnard, California
This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Guillain-Barré, Other Vaccines, Others
36814 Participants Needed
Nemvaleukin + Pembrolizumab for Ovarian Cancer
Oxnard, California
This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal 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:Primary Platinum-refractory, Mucinous Subtype, Others
Must Not Be Taking:IL-2, IL-15, Anti-PD1/PD-L1
456 Participants Needed
RSVpreF Vaccine for Bronchitis
Oxnard, California
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina.
Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States and Canada.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Metastatic Malignancy, End-stage Renal Disease, Unstable Cardiac Disease, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
38861 Participants Needed
Inclisiran for Cardiovascular Disease
Oxnard, California
This trial is testing inclisiran, an injectable drug, on people with heart disease who are already on strong cholesterol-lowering medications. The goal is to see if inclisiran can further reduce the risk of heart attacks and strokes by lowering bad cholesterol levels. Participants will receive the injection periodically. Inclisiran works by significantly reducing bad cholesterol levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Heart Failure, Active Liver Disease, Others
Must Be Taking:High-intensity Statins
17004 Participants Needed
Donanemab for Alzheimer's Disease
Thousand Oaks, California
This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:65 - 80
Key Eligibility Criteria
Disqualifiers:Mild Cognitive Impairment, Dementia, Cancer, Others
Must Not Be Taking:Cognitive Enhancers
2996 Participants Needed
Guselkumab for Psoriatic Arthritis
Thousand Oaks, California
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Rheumatoid Arthritis, Lupus, Others
Must Not Be Taking:JAK Inhibitors, Immunosuppressants
453 Participants Needed
Deucravacitinib for Psoriatic Arthritis
Thousand Oaks, California
This trial is testing a new medication called deucravacitinib to see if it can help people with psoriatic arthritis who haven't tried advanced treatments. The medication works by reducing joint swelling and pain by blocking inflammation. Deucravacitinib is a new oral drug that has shown good results in previous studies for psoriasis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Nonplaque Psoriasis, Lupus, Rheumatoid Arthritis, Fibromyalgia, Others
Must Not Be Taking:Biologics
670 Participants Needed
Bimekizumab for Hidradenitis Suppurativa
Thousand Oaks, California
This trial is testing the safety of bimekizumab, a medication for people with moderate to severe hidradenitis suppurativa (HS). Bimekizumab aims to reduce inflammation and alleviate symptoms by targeting certain proteins in the body.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Serious Infections, Others
Must Be Taking:Bimekizumab
658 Participants Needed
Litifilimab for Lupus
Thousand Oaks, California
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:
\- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.
The study will be done as follows:
* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Be Taking:Antimalarials, Steroids, Immunosuppressants
548 Participants Needed
Depemokimab for Asthma
Oxnard, California
This trial is testing a new medication called Depemokimab for people with severe asthma who have high levels of certain white blood cells. The goal is to see if switching to Depemokimab works as well as their current treatments. The medication aims to reduce these white blood cells to help control asthma symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Lung Conditions, Cancer, Smoking, Others
Must Be Taking:Mepolizumab, Benralizumab
1719 Participants Needed
Tirzepatide vs Dulaglutide for Type 2 Diabetes
Ventura, California
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Severe Hypoglycemia, Pancreatitis, Malignancy, Others
13299 Participants Needed
Sitravatinib + Nivolumab for Advanced Non-Small Cell Lung Cancer
Thousand Oaks, California
This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, EGFR Mutations, Others
577 Participants Needed
Why Other Patients Applied
"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
"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
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"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
Cell-Based Therapy for Stress Urinary Incontinence
Westlake Village, California
This trial tests a new treatment for women who still have urine leakage after surgery. The treatment uses their own muscle cells, which are injected into the urinary passage to help strengthen it. The goal is to reduce accidental urine leakage during activities like laughing or coughing. Muscle-derived cells have been previously used in treatments for urinary incontinence, showing promise in improving urethral closure and reducing symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Urge Incontinence, BMI ≥ 35, Others
Must Not Be Taking:Anticholinergics, Antidepressants, Diuretics, Others
96 Participants Needed
Upadacitinib for Ulcerative Colitis
Oxnard, California
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16 - 75
Key Eligibility Criteria
Disqualifiers:Active Infection, Tuberculosis, Malignancy, Others
950 Participants Needed
Acalabrutinib vs Standard Therapy for Chronic Lymphocytic Leukemia
Oxnard, California
This trial compares acalabrutinib with rituximab combined with either idelalisib or bendamustine in patients with chronic lymphocytic leukemia who have already been treated before. Acalabrutinib stops cancer cells from growing, while rituximab helps the immune system kill them. Idelalisib blocks growth signals, and bendamustine damages cancer cell DNA. Acalabrutinib has been approved for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia in the US.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Lymphoma, Richter's Syndrome, Others
Must Not Be Taking:BCL-2 Inhibitors, BCR Inhibitors, Others
310 Participants Needed
This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.
2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior CLL Treatment, CNS Lymphoma, Cardiovascular Disease, Others
Must Not Be Taking:Corticosteroids, Anticoagulants, PPIs, CYP3A Inhibitors
535 Participants Needed
Chemotherapy + Trastuzumab for Breast Cancer
Oxnard, California
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
Orforglipron for Obesity
Thousand Oaks, California
The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Recent Heart Condition, Others
Must Not Be Taking:GLP-1 Receptor Agonists
800 Participants Needed
Vicadrostat + Empagliflozin for Heart Failure
Thousand Oaks, California
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.
In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between 1 and about 3.5 years. During this time, they can continue their regular treatment for heart failure.
Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The 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
Key Eligibility Criteria
Disqualifiers:Recent MI, Stroke, Heart Transplant, Others
Must Not Be Taking:MRAs, Potassium-sparing Diuretics
4200 Participants Needed
Balcinrenone + Dapagliflozin for Heart Failure
Thousand Oaks, California
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Recent ACS, Major Surgery, Type 1 Diabetes, Severe Pulmonary Disease, Others
Must Not Be Taking:CYP3A4 Inhibitors
4800 Participants Needed
Ribociclib + Endocrine Therapy for Breast Cancer
Westlake Village, California
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastases, HIV, Hepatitis, Others
Must Be Taking:Endocrine Therapy
5101 Participants Needed
Subcutaneous Risankizumab for Psoriasis
Thousand Oaks, California
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored.
Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally.
The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Non-plaque Psoriasis, Allergic Reactions, Others
Must Not Be Taking:IL-23 Inhibitors
214 Participants Needed
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