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Hormonal, Metabolic, and Signaling Interactions in PAH
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Scleroderma Associated Pulmonary Arterial Hypertension
Appetite Suppressant Associate PAH
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which
underlie PAH will improve pulmonary vascular function and consequences of the disease. expand
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease. Type: Observational Start Date: Sep 2012 |
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chem1
Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Liver
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in
addition to standard of care chemotherapy versus standard of care chemotherapy alone in
treating patients with colorectal cancer that has spread to the liver (liver metastases)
and cannot be removed by surgery (unr1 expand
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases. Type: Interventional Start Date: Oct 2023 |
Epidemiology of Silent and Overt Strokes in Sickle Cell Disease
Anemia, Sickle Cell
Sickle Cell Disease
Stroke
Sickle Cell Thalassemia
Sickle Cell-Beta0-Thalassemia
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000
individuals, often poor and underserved, in the US. Silent and overt strokes contribute
significantly to morbidity in adults with SCD, resulting in functional impairment,
challenges with school and job performance, and pr1 expand
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with silent strokes and ~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults. Type: Observational Start Date: Jun 2017 |
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
Pulmonary Nodule
This is a prospective, multicenter observational study aim at estimating the potential
clinical utility of the CBM and at establishing the SOPs and protocols for a future
randomized control trial. expand
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial. Type: Observational Start Date: Mar 2024 |
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Loc1
Solid Tumor
Non-Small Cell Lung Cancer
Head and Neck Cancer
Melanoma
Gastric Cancer
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose
(RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1
checkpoint inhibitor (CPI) pembrolizuma1 expand
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Type: Interventional Start Date: Dec 2019 |
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Hypertension, Pregnancy-Induced
Postpartum Preeclampsia
Hypertension; Maternal
Investigators propose a comprehensive management program for postpartum patients with HDP
who are at risk for severe maternal morbidity and mortality. Our program will emphasize
three key components: 1) self-monitoring of blood pressures with app-based reporting
connected to our electronic health r1 expand
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes. Type: Interventional Start Date: May 2023 |
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oroph1
Metastatic Oropharyngeal Carcinoma
Recurrent Oropharyngeal Carcinoma
This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV)
vaccines in combination with pembrolizumab work in treating patients with oropharyngeal
cancer that has come back (recurrent) or that has spread from where it first started
(primary site) to other places in th1 expand
This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone. Type: Interventional Start Date: May 2023 |
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural
Hearing Loss
Hearing Loss, Bilateral
The current study is a randomized multi-center clinical trial that investigates the role
an intraoperative hearing monitoring system (electrocochleography) has on helping to save
residual hearing in patients undergoing cochlear implantation (CI). expand
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI). Type: Interventional Start Date: Nov 2021 |
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smo1
Smoldering Plasma Cell Myeloma
This phase III trial studies how well lenalidomide and dexamethasone works with or
without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in
chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the
growth of tumor cells, either by kill1 expand
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma. Type: Interventional Start Date: Sep 2019 |
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed1
ALK Gene Rearrangement
ALK Gene Translocation
ALK Positive
Stage IB Non-Small Cell Lung Carcinoma AJCC v7
Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients
with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a
mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in
ALK can make it very active and im1 expand
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Type: Interventional Start Date: Mar 2015 |
Ruxolitinib + Allogeneic Stem Cell Transplantation in AML
Acute Myeloid Leukemia
Acute Myeloid Leukemia in Remission
Allogeneic Stem Cell Transplantation
This research study is studying a drug that may help decrease the chances of relapse
after Allogeneic Stem Cell transplantation for Acute Myeloid Leukemia. The name of the
study drug involved in this study is:
• Ruxolitinib expand
This research study is studying a drug that may help decrease the chances of relapse after Allogeneic Stem Cell transplantation for Acute Myeloid Leukemia. The name of the study drug involved in this study is: • Ruxolitinib Type: Interventional Start Date: Nov 2017 |
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Di1
Brain Cancer
Breast Cancer
Bladder Cancer
Cervical Cancer
Colorectal Cancer
This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical,
colorectal, endometrial, esophageal, gast1 expand
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate). These cancers were selected based on the existing clinical landscape and treatment availability. Type: Observational Start Date: May 2022 |
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
Relapsing-remitting Multiple Sclerosis (RRMS)
The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity
between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to
demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference
product (RP) based on assessment of the suppress1 expand
The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI). Type: Interventional Start Date: Jan 2025 |
ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Int1
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
The primary purpose of this study is to evaluate the safety and tolerability of ION440. expand
The primary purpose of this study is to evaluate the safety and tolerability of ION440. Type: Interventional Start Date: Oct 2024 |
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Partic1
Chronic Graft-versus-host-disease
This study will be conducted to determine the preliminary efficacy of axatilimab in
combination with ruxolitinib and to assess the contribution of axatilimab to the
combination treatment effect in participants with cGVHD. expand
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD. Type: Interventional Start Date: Oct 2024 |
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (B1
Alzheimer Disease, Early Onset
The purpose of this study is to assess the effectiveness, safety, and tolerability of
BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's
Disease. expand
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. Type: Interventional Start Date: Mar 2024 |
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 t1
Wheezing
Asthma
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of
dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or
recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be
a 52-week, randomized, double-blin1 expand
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period). Type: Interventional Start Date: Jan 2024 |
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therap1
Multiple Myeloma
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically
found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause
bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are
available, but MM can come back (relapse1 expand
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. 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 questionnaires. Type: Interventional Start Date: May 2024 |
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately t1
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants
with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are
that at least 1 tulisokibart dose level is superior to Placebo in the proportion of
participants achieving clinical remiss1 expand
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 2023 |
Nectero EAST System Clinical Study
Abdominal Aortic Aneurysm
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 of1 expand
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. Type: Interventional Start Date: Oct 2023 |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory La1
Recurrent Langerhans Cell Histiocytosis
Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib
(DAY101) in treating patients with Langerhans cell histiocytosis that is growing,
spreading, or getting worse (progressive), has come back (relapsed) after previous
treatment, or does not respond to therapy (r1 expand
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis. Type: Interventional Start Date: Mar 2024 |
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
Endothelial Dysfunction
Vascular Diseases
Kidney Injury
Brain Disease
Vascular Inflammation
The goal of this mechanistic clinical trial is to learn about the effects of medications
called soluble guanylyl cyclase stimulators on vascular function and markers of kidney
and brain injury in patients having heart surgery. The main questions it aims to answer
are:
1. Does soluble guanylyl cy1 expand
The goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. The main questions it aims to answer are: 1. Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo? 2. Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo? Participants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury. This will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery. Type: Interventional Start Date: May 2023 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Part1
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus
on participants who have either active subacute CLE or chronic CLE, or both. They may
also have systemic lupus erythematosus (SLE1 expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? 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 CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks Type: Interventional Start Date: Sep 2022 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence1
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
Brain Metastases
This trial will be a randomized controlled study comparing the efficacy and safety of
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care. expand
This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care. Type: Interventional Start Date: Apr 2021 |
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