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A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Daewoong Pharmaceutical Co. LTD.
Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the
safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
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This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic...
Amgen
Atherosclerotic Cardiovascular Disease
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a))
levels among participants with a history of ASCVD as defined by their medical history and is
2-fold:
- Evaluate the distribution of Lp(a) value in the overall participants with documented... expand
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions Type: Interventional Start Date: Apr 2022 |
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
PureTech
Idiopathic Pulmonary Fibrosis
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of
LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
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This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Boehringer Ingelheim
Bronchiectasis
This study is open to adults with bronchiectasis. People can join the study if they produce
sputum and have a history of flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people
with bronchiectasis.... expand
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Mar 2022 |
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants...
Genentech, Inc.
Non-Hodgkin Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab
subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of
non-Hodgkin's lymphoma [NHL]).
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This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]). Type: Interventional Start Date: Feb 2022 |
A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic...
Bayer
Non-diabetic Chronic Kidney Disease
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney
disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help
people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It... expand
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments. Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative...
Amgen
Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of
clinical remission in participants with moderately to severely active ulcerative colitis
(UC).
Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo... expand
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product. Type: Interventional Start Date: Jan 2022 |
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Janssen Research & Development, LLC
Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to
placebo in participants with generalized myasthenia gravis (gMG).
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The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). Type: Interventional Start Date: Jul 2021 |
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell...
Janssen Research & Development, LLC
Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to
placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult
participants with new-onset or relapsing giant cell arteritis (GCA).
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The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA). Type: Interventional Start Date: Dec 2020 |
Changing Talk Online Training (CHATO) National Trial
University of Kansas Medical Center
Dementia
Alzheimer Disease
Communication
The National Plan to Address Alzheimer's disease has identified education of dementia care
providers as a top priority to address the need for quality care for the population of
persons with dementia that will triple in the next 30 years. This study will test new online
interactive... expand
The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care. Type: Interventional Start Date: Apr 2021 |
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Boehringer Ingelheim
Depressive Disorder, Major
This study is open to adults with depression (major depressive disorder) for whom standard
treatment with antidepressants alone does not work sufficiently. The purpose of the trial is
to find out whether a medicine called BI 1358894 helps to improve symptoms of depression.... expand
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets twice a day. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants. Type: Interventional Start Date: Nov 2020 |
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With...
BioNTech SE
Colorectal Cancer Stage II
Colorectal Cancer Stage III
This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of
RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive,
surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon
cancer.... expand
This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer. Type: Interventional Start Date: Mar 2021 |
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for...
NovoCure GmbH
Glioblastoma Multiforme
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy
(RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy
and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued
following... expand
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. Type: Interventional Start Date: Dec 2020 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of
HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+
confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.... expand
This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and
capecitabine,... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Nov 2019 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After...
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy
uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex
hormones,... expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients...
MediciNova
Amyotrophic Lateral Sclerosis
A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study
to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12
months followed by a 6-month open-label extension phase.
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A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase. Type: Interventional Start Date: May 2020 |
Defining Clinical Endpoints in Limb Girdle Muscular Dystrophy (LGMD)
Virginia Commonwealth University
Limb Girdle Muscular Dystrophy
Muscular Dystrophies
Limb Girdle Muscular Dystrophy comprise a group of disorders made up of over 30 mutations
which share a common phenotype of progressive weakness of the shoulder and hip girdle
muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the
four... expand
Limb Girdle Muscular Dystrophy comprise a group of disorders made up of over 30 mutations which share a common phenotype of progressive weakness of the shoulder and hip girdle muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the four most common muscular dystrophies. The overall goal of project 1 is to define the key phenotypes as measured by standard clinical outcome assessments (COAs) for limb girdle muscular dystrophies (LGMD) to hasten therapeutic development. Type: Observational Start Date: Jun 2019 |
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance...
National Cancer Institute (NCI)
Lung Non-Squamous Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed
by pemetrexed and carboplatin with or without pembrolizumab after disease progression is
superior to induction with pembrolizumab, pemetrexed and carboplatin followed by
pembrolizumab... expand
This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. 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. Chemotherapy drugs, such as pemetrexed and carboplatin, 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. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer. Type: Interventional Start Date: Feb 2019 |
Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Seagen Inc.
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Exocrine Pancreatic Cancer
Carcinoma, Squamous Cell of Head and Neck
This trial will study tisotumab vedotin to find out whether it is an effective treatment for
certain solid tumors and what side effects (unwanted effects) may occur. There are four parts
to this study.
- In Part A, the treatment will be given to participants every 3 weeks... expand
This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are four parts to this study. - In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). - In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. - In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 4-week cycle. - In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either: - Pembrolizumab or, - Pembrolizumab and carboplatin, or - Pembrolizumab and cisplatin Type: Interventional Start Date: Jun 2018 |
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... 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 |
A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and...
Celgene
Multiple Myeloma
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study
consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in
combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX
and BTZ and... expand
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma. Type: Interventional Start Date: Oct 2016 |
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