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230 Clinical Trials near Del Mar, 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 PowerCabozantinib + Atezolizumab for Prostate Cancer
La Jolla, California
This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Spinal Cord Compression, Others
Must Be Taking:NHT
575 Participants Needed
AVP-786 for Agitation in Alzheimer's Disease
La Jolla, California
This trial tests a combination of two drugs taken by mouth to help calm severe agitation in people with Alzheimer's disease by balancing brain chemicals.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Non-Alzheimer's Dementia, Unstable Systemic Diseases, Myasthenia Gravis, Others
183 Participants Needed
Tazemetostat + Lenalidomide + Rituximab for Follicular Lymphoma
La Jolla, California
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.
Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.
Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Tazemetostat, Lenalidomide, Brain Metastases, Others
Must Be Taking:Lenalidomide
612 Participants Needed
Nemolizumab for Prurigo Nodularis
San Diego, California
This trial is testing the safety of nemolizumab, a medication for people with prurigo nodularis. Prurigo nodularis is a skin condition that causes itchy, hard lumps. Nemolizumab aims to reduce itching and swelling by blocking certain signals 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, Alcohol Abuse, Others
500 Participants Needed
Belzutifan vs Everolimus for Renal Cell Carcinoma
La Jolla, California
The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiac Disease, Hypertension, Hepatic Impairment, Others
Must Not Be Taking:CYP3A4 Inhibitors, CYP3A4 Inducers
755 Participants Needed
Vorasidenib for Glioma
La Jolla, California
This trial is testing an oral medication called vorasidenib in patients with a specific type of brain tumor that has a genetic mutation. The drug aims to block proteins that help the tumor grow, potentially slowing or stopping its growth.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Prior Anticancer Therapy, High-risk Features
Must Not Be Taking:IDH Inhibitors
331 Participants Needed
Osimertinib + Chemotherapy for Non-Small Cell Lung Cancer
La Jolla, California
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).
Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.
In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer.
The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.
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:Uncontrolled Hypertension, Active Infection, Others
Must Be Taking:EGFR-TKIs
587 Participants Needed
Peginterferon Beta-1a for Multiple Sclerosis
San Diego, California
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:10 - 18
Key Eligibility Criteria
Disqualifiers:Progressive MS, Severe Allergies, Others
Must Not Be Taking:PEGylated IFN Β-1a
152 Participants Needed
Daratumumab + Lenalidomide for Multiple Myeloma
La Jolla, California
This trial is testing whether adding daratumumab to lenalidomide is more effective than using lenalidomide alone for patients with newly diagnosed multiple myeloma. These patients still have detectable cancer cells after initial treatments. Daratumumab helps the immune system find and kill cancer cells, while lenalidomide boosts the immune system and stops cancer growth.
No Placebo Group
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:Lenalidomide
200 Participants Needed
Durvalumab + Bevacizumab for Liver Cancer
La Jolla, California
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastasis, Macrovascular Invasion, Hepatic Encephalopathy, Others
908 Participants Needed
Apalutamide + ADT for Prostate Cancer
La Jolla, California
This trial is testing if using apalutamide and hormone therapy around the time of surgery can help men with high-risk prostate cancer by reducing the hormones that help the cancer grow.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Distant Metastasis, Prior Prostate Therapy, Heart Disease, Others
Must Be Taking:Androgen Deprivation Therapy
2517 Participants Needed
Pembrolizumab + Radiotherapy for Head and Neck Cancer
La Jolla, California
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
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:Metastases, Immunodeficiency, Autoimmune, Others
Must Not Be Taking:Immunosuppressants, Steroids, Live Vaccines, Others
714 Participants Needed
Medications for PTSD-Related Insomnia
San Diego, California
Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone or eszopiclone can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, TBI, Others
Must Not Be Taking:Sleep Medications
774 Participants Needed
KRT-232 for Myelofibrosis
La Jolla, California
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Splenectomy, Hemorrhage, Stroke, Transplant, Others
385 Participants Needed
Photodynamic Therapy for Basal Cell Carcinoma
San Diego, California
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Porphyria, Cardiovascular Disease, Others
Must Not Be Taking:Immunosuppressants, Cytotoxic Drugs
187 Participants Needed
Neoadjuvant Daromun + Surgery for Melanoma
La Jolla, California
The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uveal Melanoma, Distant Metastases, Active Infections, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
186 Participants Needed
Adagloxad Simolenin + OBI-821 for Triple Negative Breast Cancer
La Jolla, California
This trial is testing a new treatment that combines two substances to help the immune system fight a specific type of high-risk breast cancer. It focuses on patients whose cancer does not respond well to usual treatments.
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 Disease, Others
Must Be Taking:Taxane, Anthracycline
575 Participants Needed
Omitting Radiation Therapy for Breast Cancer
Encinitas, California
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:35+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Prior Chest Radiation, Others
Must Be Taking:Endocrine Therapy
2140 Participants Needed
Guselkumab for Crohn's Disease
La Jolla, California
This trial is testing guselkumab, a medication that reduces inflammation, in patients with Crohn's disease. It aims to find the best dose and check its safety and effectiveness. The medication works by calming the immune system to reduce symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Symptomatic Strictures, Others
1409 Participants Needed
GM T Cell Therapy Long-Term Follow-Up for Cancer
La Jolla, California
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
1541 Participants Needed
Why Other Patients Applied
"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 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 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
"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 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
Abrocitinib for Atopic Dermatitis/Eczema
Encinitas, California
This trial is testing a pill called Abrocitinib to help people aged 12 and older with severe eczema. It aims to see if the pill can reduce inflammation and itching by blocking certain body chemicals. The study includes patients who have already participated in a related study.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Other Skin Diseases, Psychiatric Conditions, Others
3166 Participants Needed
HAV vs AVF for Hemodialysis Access
La Jolla, California
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Peripheral Arterial Disease, Cancer, Others
Must Not Be Taking:Immunosuppressants, Cytotoxic Agents
240 Participants Needed
Apalutamide + Abiraterone Acetate for Prostate Cancer
San Diego, California
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Androgen Deprivation Therapy, Seizure, Hypertension, Others
Must Not Be Taking:CYP17 Inhibitors, 5-alpha Reductase
504 Participants Needed
Atezolizumab After Chemotherapy for Lung Cancer
Encinitas, California
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
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, Autoimmune Diseases, Cardiovascular, Others
Must Be Taking:Cisplatin-based Chemotherapy
1280 Participants Needed
Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia
Encinitas, California
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years
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:Richter's Transformation, PML, HIV, Others
Must Not Be Taking:Warfarin, Marcumar, Phenprocoumon, Others
445 Participants Needed
Chemotherapy + Radiation Therapy for Head and Neck Cancer
Encinitas, California
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Prior Invasive Malignancy, Severe Cardiac Disease, Severe Infections, Autoimmune Disease, Others
Must Not Be Taking:Immunosuppressants, Anti-PD-1 Agents
613 Participants Needed
RGN-259 for Neurotrophic Keratopathy
San Diego, California
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ocular Surgery, Autoimmune Disease, Others
Must Not Be Taking:Lacrimation Drugs, Immunosuppressives
70 Participants Needed
TAK-788 vs Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer
La Jolla, California
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.
Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Systemic Treatment, Other Malignancy, Uncontrolled Hypertension, Others
Must Not Be Taking:CYP3A Inhibitors, CYP3A Inducers
354 Participants Needed
Vicadrostat + Empagliflozin for Heart Failure
Encinitas, 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
Ritlecitinib for Alopecia Areata
Encinitas, California
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.
Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.
This study is seeking participants who:
* Are 12 years of age or older
* Have a diagnosis of alopecia areata
* Have lost 50% or more of the hair on their scalp
* Do not have any other conditions that causes hair loss
* Are willing to stop all other treatments that they may be taking for alopecia areata
About 550 participants will take part in in this study.
Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.
The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.
People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:
* alopecia areata assessment,
* physical examinations,
* hearing tests,
* blood tests,
* x-ray,
* ECG (electrocardiogram),
* photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Other Alopecia, Severe Allergies, Infections, Others
Must Not Be Taking:Antibiotics, Antivirals, Antifungals, Others
550 Participants Needed
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