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A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared...
Amgen
Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the
efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed
by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with
uncontrolled refractory gout.
The... expand
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time. Type: Interventional Start Date: Mar 2024 |
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in...
Genentech, Inc.
Locally Advanced Solid Tumors
Recurrent Solid Tumors
Metastatic Solid Tumors
This is a first-in-human Phase I, open-label, dose-escalation and expansion study
designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity,
pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and
in combination with atezolizumab in participants... expand
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion. Type: Interventional Start Date: Nov 2023 |
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With...
Hoffmann-La Roche
Huntington Disease
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with
placebo in participants with prodromal and early manifest Huntington's Disease. expand
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease. Type: Interventional Start Date: Feb 2023 |
Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
National Human Genome Research Institute (NHGRI)
Genetic Disease
Without an explanation for severe and sometimes life-threatening symptoms, patients and
their families are left in a state of unknown. Many individuals find themselves being
passed from physician to physician, undergoing countless and often repetitive tests in
the hopes of finding answers and insight... expand
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases. Type: Observational Start Date: Sep 2015 |
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 |
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
National Institute of Allergy and Infectious Diseases (NIAID)
Liver Transplant
This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective
liver transplant recipients to determine the efficacy of two doses of
Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant.
The primary objective is to assess the effect of pre-transplant... expand
This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective liver transplant recipients to determine the efficacy of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant. The primary objective is to assess the effect of pre-transplant (Tx) Triplex vaccination on duration of CMV antiviral therapy (AVT) within the first 100 days post-Tx in CMV seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients (LTxRs). A protocol-mandated preemptive therapy (PET) will be used for CMV disease prevention in D+R- LTxRs. Type: Interventional Start Date: Mar 2024 |
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 |
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 to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin...
Hoffmann-La Roche
Primary IgA Nephropathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary
IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite
optimized supportive care. expand
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care. Type: Interventional Start Date: Aug 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 |
The Impact of a Virtual Magic Trick Training Program
University of Alabama at Birmingham
Autism
Pervasive Developmental Disorder
The proposed project will attempt to confirm the benefits of a structured magic trick
training program (MTTP) experience in adolescents with autism. Benefits of participating
in a 6-week virtual MTTP will be evaluated using validated assessments to measure
social-emotional competencies. expand
The proposed project will attempt to confirm the benefits of a structured magic trick training program (MTTP) experience in adolescents with autism. Benefits of participating in a 6-week virtual MTTP will be evaluated using validated assessments to measure social-emotional competencies. Type: Interventional Start Date: Mar 2023 |
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or
without panitumumab works in treating patients with KRAS G12C mutant solid tumors that
may have spread from where it first started to nearby tissue, lymph nodes, or distant
parts of the body (advanced). Sotorasib is... expand
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation. Type: Interventional Start Date: Aug 2024 |
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (...
CSL Behring
Traumatic Injury
This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, large simple trial to investigate the efficacy and safety of a single
intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed
or suspected acute major bleeding and /... expand
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion. Type: Interventional Start Date: Mar 2023 |
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe...
Janssen Research & Development, LLC
Depressive Disorder, Major
Anhedonia
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo
as adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate to severe anhedonia
(ANH+) who have had an inadequate response... expand
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Type: Interventional Start Date: Dec 2022 |
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to assess the long-term safety and tolerability of
aticaprant administered as adjunctive therapy to a current antidepressant (selective
serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor
[SNRI]) in all participants with major depressive... expand
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD). Type: Interventional Start Date: Sep 2022 |
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients...
Hoffmann-La Roche
NMDAR Autoimmune Encephalitis
LGI1 Autoimmune Encephalitis
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and
pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid
receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. expand
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. Type: Interventional Start Date: Sep 2022 |
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients...
Shanghai Henlius Biotech
Extensive Stage Small Cell Lung Cancer
This is a randomized, open-label study of Serplulimab plus chemotherapy
(Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously
untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab):... expand
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: - Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) - Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide) Type: Interventional Start Date: Nov 2022 |
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
Novartis Pharmaceuticals
Chronic Myelogenous Leukemia - Chronic Phase
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who
have been previously treated with one prior ATP- binding site TKI with discontinuation
due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly
diagnosed CML-CP patients who may... expand
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort. Type: Interventional Start Date: Nov 2022 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration
of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac
arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion of children that... expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy...
Alliance for Clinical Trials in Oncology
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to
the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or
B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called
inotuzumab, linked to a drug, called... expand
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning. Type: Interventional Start Date: Feb 2023 |
Evolutâ„¢ EXPAND TAVR II Pivotal Trial
Medtronic Cardiovascular
Moderate Aortic Valve Stenosis
Obtain safety and effectiveness data to support indication expansion for the Medtronic
TAVR System to include patients with moderate, AS. expand
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS. Type: Interventional Start Date: Apr 2022 |
A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib...
BeiGene
Relapsed/Refractory Multiple Myeloma
Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in
combination with dexamethasone and carfilzomib intravenously across two cohorts with a
monotherapy component as well. expand
Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well. Type: Interventional Start Date: Sep 2021 |
Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic...
Colette Shen
Breast Cancer
Brain Metastases, Adult
This study is a Phase I/II study evaluating the safety and effectiveness of focused
radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for
patients with brain metastases from triple negative or BRCA-mutated breast cancers.
This study will have a Phase I portion in... expand
This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section). Once the subject has recovered from SRS (based on investigator discretion) that will be considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death. Type: Interventional Start Date: Mar 2022 |
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