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Denosumab for Type 1 Diabetes
City of Hope Medical Center
Type 1 Diabetes
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that
make insulin. The injured beta cells can then no longer make the needed amount of insulin
to stay healthy. However, in the early stages of T1D, some beta cells are still alive and
functioning. Treatment to protect... expand
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D. Type: Interventional Start Date: Sep 2024 |
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or
refractory multiple myeloma (RRMM). expand
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Type: Interventional Start Date: Jan 2024 |
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment...
Biosense Webster, Inc.
Drug Refractory Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate safety and effectiveness of the Biosense
Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and
TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in
treatment of participants with paroxysmal atrial... expand
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. Type: Interventional Start Date: Dec 2023 |
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent...
Boston Scientific Corporation
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung...
Sanofi
Lung Transplant Rejection
This double-blind, randomized, placebo-controlled, multinational, multicenter,
parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of
belumosudil compared with placebo, both administered on top of azithromycin and
standard-of-care regimen of immunosuppression in male or... expand
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis...
Incyte Corporation
Prurigo Nodularis
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream
in participants with Prurigo Nodularis (PN). expand
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN). Type: Interventional Start Date: Jun 2023 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and...
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease
worsening in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics), to learn if fazirsiran reduces... expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional Start Date: Mar 2023 |
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Olatec Therapeutics LLC
Acute Gout Flare
Gout Attack
Gout Flare
Gouty Arthritis
Gout
The purpose of this trial is to investigate the efficacy and safety of dapansutrile
(OLT1177®) tablets in subjects with an acute gout flare. expand
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female...
Sanofi
Fabry Disease
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3
study, in which participants will be randomized to venglustat versus standard of care
therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of
venglustat on left ventricular mass index (LVMI)... expand
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 34 months with the total study duration up to 4.4 years maximum. Type: Interventional Start Date: May 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period expand
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 2022 |
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft...
Equillium
Graft Versus Host Disease
GVHD
Acute-graft-versus-host Disease
Acute GVHD
aGVHD
This is a multi-center study to compare the efficacy and safety of itolizumab versus
placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI
involvement, in combination with corticosteroids expand
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids Type: Interventional Start Date: Apr 2022 |
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Seagen Inc.
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Esophageal Squamous Cell Carcinoma
Ovarian Neoplasms
Melanoma
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with
pembrolizumab in participants with solid tumors. It will also study the side effects of
this drug. A side effect is anything a drug does to your body besides treating your
disease.
Participants will have solid... expand
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers. Type: Interventional Start Date: Oct 2022 |
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic...
Hoffmann-La Roche
Metastatic Colorectal Cancer
This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy as single agents or combinations, in participants
with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per
treatment arm-specific definition. Eligible... expand
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results. Type: Interventional Start Date: Oct 2021 |
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive...
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone. expand
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone. Type: Interventional Start Date: Jul 2022 |
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Genmab
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
The purpose of this trial is to measure the safety and effectiveness of epcoritamab
(EPKINLY™), either by itself or together with other therapies, when treating subjects
with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to
identify the most appropriate dose of epcoritamab,... expand
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating subjects with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: - The total trial duration will be up to 6 years. - The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years. - The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. - All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have IV infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment. Type: Interventional Start Date: Nov 2020 |
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid...
Incyte Corporation
Myelofibrosis
Myelodysplastic Syndrome
Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
Myeloproliferative Neoplasm
Relapsed or Refractory Primary Myelofibrosis
The purpose of this study is to evaluate the safety, tolerability, and preliminary
efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants
with myelofibrosis (MF) and other myeloid neoplasms. expand
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms. Type: Interventional Start Date: Feb 2021 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
NRG Oncology
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy... expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Human Papillomavirus Type 16
Cervical Intraepithelial Neoplasia Grade II
Cervical Intraepithelial Neoplasia, Grade III
The primary goal of this phase I open label study is to determine the safety and
tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM)
injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19
years), with biopsy confirmed cervical intraepithelial... expand
The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+. Type: Interventional Start Date: Sep 2020 |
Personalized Theratyping Trial
University of Alabama at Birmingham
Cystic Fibrosis
The purpose of this study is to explore the use of off-label CFTR modulators that may
affect CFTR function in patients with CFTR mutations that are not currently approved for
these drugs. expand
The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. Type: Interventional Start Date: Aug 2019 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic...
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety
of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will
include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in
subjects with relapsed or refractory CLL or... expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Nov 2017 |
Platform Clinical Study for Conquering Scleroderma
Scleroderma Research Foundation, Inc.
Interstitial Lung Disease Due to Systemic Disease
Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products
(IPs) compared with placebo on the change from baseline to the end of the treatment
period at Week 52 in lung capacity in participants with Interstitial Lung Disease
Secondary to Systemic Sclerosis. expand
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis. Type: Interventional Start Date: Apr 2024 |
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Lantheus Medical Imaging
Prostate Cancer
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can
safely and accurately detect the presence or absence of prostate cancer growing beyond
the prostate gland in men with favorable intermediate risk prostate cancer.
Participants will receive a single dose of PYLARIFY... expand
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan. Type: Interventional Start Date: Feb 2024 |
Early Parkinson's Disease Monotherapy With CVN424
Cerevance Beta, Inc.
Parkinson's Disease
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150
milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will
be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The
purpose of this study is to measure effect on... expand
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies. Type: Interventional Start Date: Sep 2023 |
Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
University of Alabama at Birmingham
Amyotrophic Lateral Sclerosis
Myasthenia Gravis
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise
program (YBEP) will improve breathing, speech, and emotional well-being in people with
amyotrophic lateral sclerosis (ALS). expand
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS). Type: Interventional Start Date: Nov 2023 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
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