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A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy...
Novartis Pharmaceuticals
Sjogrens Syndrome
The purpose of this study is to measure the long-term safety and tolerability of
ianalumab in participants with Sjogrens syndrome who have previously completed treatment
from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302).
- The study treatment is ianalumab 300 mg in a... expand
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe. Participants will be given the opportunity to self-inject at home on some visits after receiving training. Type: Interventional Start Date: Oct 2023 |
PRO1184 for Advanced Solid Tumors
Genmab
Platinum-Resistant Ovarian Cancer
Platinum Sensitive Ovarian Cancer (PSOC)
High Grade Epithelial Ovarian Cancer
High Grade Serous Ovarian Cancer
Primary Peritoneal Carcinoma
This study will test the safety, including side effects, and determine the
characteristics of a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic)
or cannot be removed with surgery (unresectable). expand
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). Type: Interventional Start Date: Dec 2022 |
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
University of Kansas Medical Center
Down Syndrome
Physical Inactivity
The investigators are assessing acceptability, appropriateness, and feasibility of an
remote choreographed exercise intervention using validated scales alongside qualitative
data among young adults with Down Syndrome. Participants will take part in a 12-week
exercise program with two 35-minute session... expand
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. The aims of the project are to: - Assess the feasibility of a 12 week remotely delivered group dance intervention. - Assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention. - Assess the intensity and total energy expenditure of remotely delivered group dance sessions. Type: Interventional Start Date: Aug 2024 |
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With...
University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to
insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated
with reduced cognitive performance, physical function, psychological well-being, quality
of life, and occupational function,... expand
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3). Type: Interventional Start Date: Jul 2024 |
Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory...
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in
participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
BicycleTx Limited
Metastatic Urothelial Cancer
This is a global, multicenter, randomized, open-label study, with an adaptive design. The
main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide
pevedotin) as monotherapy and in combination with pembrolizumab in participants with
locally advanced or metastatic urothelial... expand
This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC. Type: Interventional Start Date: Jan 2024 |
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With...
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Sclerosis
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug
levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or
Progressive Forms of Multiple Sclerosis (PMS). expand
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS). Type: Interventional Start Date: Mar 2024 |
Parkinson's Disease Progression Study
Koneksa Health
Parkinson Disease
Disease Progression Study expand
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Burn Pivotal Study
SpectralMD
Burns
Wound Heal
Wounds and Injuries
The purpose of this study is to validate the algorithm for burn healing assessment by the
Spectral MD DeepView device which would provide burn healing potential assessment. expand
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment. Type: Observational Start Date: Dec 2023 |
AMX0035 and Progressive Supranuclear Palsy
Amylyx Pharmaceuticals Inc.
Progressive Supranuclear Palsy
PSP
Neurodegenerative Diseases
Atypical Parkinsonism
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. expand
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. Type: Interventional Start Date: Dec 2023 |
Changes in Resting Metabolic Rate Following Orthopedic Surgery
University of Kansas Medical Center
Metabolism; Disorder, Postprocedural
Resting Metabolic Rate
Post Operative Nutrition
This project is intended to determine the magnitude and duration of RMR changes in
patients receiving orthopedic surgery. The result will help to guide postoperative
nutrition recommendations in patients receiving orthopedic surgery. expand
This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery. Type: Observational Start Date: Oct 2023 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the
efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary
fibrosis (BEACON-IPF). expand
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Bristol-Myers Squibb
Myelodysplastic Syndromes
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when
administered at the maximum approved dose in low-risk Myelodysplastic Syndrome
participants who require red blood cell transfusions. expand
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Donor-Derived Anti-CD33 CAR T Cell Therapy (VCAR33) in Patients With Relapsed or Refractory AML After...
Vor Biopharma
Leukemia, Myeloid, Acute
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived
anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with
relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen
(HLA)-matched allogeneic hematopoietic cell... expand
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (alloHCT). Type: Interventional Start Date: Dec 2023 |
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor
(CAR) T-cell therapy for the treatment... expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening. expand
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Type: Interventional Start Date: Dec 2023 |
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Pfizer
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
The purpose of this study is to learn about the effects, safety and how PF-06823859 is
processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus
erythematosus (SLE) showing some skin symptoms.
This study is seeking for participants who:
- are adults of 18 years of age... expand
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: - are adults of 18 years of age or older. - are confirmed to have CLE or SLE with involvement of the skin. - have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period. Type: Interventional Start Date: Jul 2023 |
Myositis Interstitial Lung Disease Nintedanib Trial
Rohit Aggarwal, MD
Myositis Associated Interstitial Lund Disease (MA-ILD)
This research study will evaluate safety and how well the study drug, nintedanib improve
symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
Interstitial lung disease is a disorder caused by the abnormal accumulation of cells
structures between air sacs of the lungs... expand
This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine). Type: Interventional Start Date: Aug 2023 |
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
Respiratory Distress Syndrome, Acute
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of
GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible
after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after
the first dose and will continue with... expand
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days. Type: Interventional Start Date: Apr 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of... expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Verismo Therapeutics
Ovarian Cancer
Cholangiocarcinoma Recurrent
Mesothelioma, Malignant
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and
potential activity of a single intravenous (IV) dose of SynKIR-110 administered to
subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and
cholangiocarcinoma. expand
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma. Type: Interventional Start Date: Mar 2023 |
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Eli Lilly and Company
Breast Neoplasms
The main purpose of this study is to measure how well imlunestrant works compared to
standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for... expand
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Type: Interventional Start Date: Oct 2022 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab...
Gilead Sciences
Triple Negative Breast Cancer
PD-L1 Positive
The primary objective of this study is to compare the progression-free survival (PFS)
between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's
choice (TPC) and pembrolizumab in participants with previously untreated, locally
advanced inoperable or metastatic triple-negative... expand
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Type: Interventional Start Date: Jul 2022 |
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