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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 the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's...
Hoffmann-La Roche
Parkinsons Disease
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate
the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with
Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
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This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication. Type: Interventional Start Date: May 2021 |
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
Eureka Therapeutics Inc.
Hepatocellular Carcinoma
Liver Cancer
Liver Neoplasm
Metastatic Liver Cancer
Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an
autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein
(AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma
(HCC).
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Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC). Type: Interventional Start Date: Apr 2021 |
Artificial Urinary Sphincter Clinical Outcomes
Boston Scientific Corporation
Stress Urinary Incontinence
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary
incontinence as measured by pad weight tests.
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To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests. Type: Observational Start Date: Oct 2019 |
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 |
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 |
DALY 2.0 USA/ MB-CART2019.1 for DLBCL
Miltenyi Biomedicine GmbH
DLBCL
This is an open label, single arm, phase II study to determine the efficacy, safety and PK
(persistence) of MBCART2019.1 cells in adults with relapsed or refractory DLBCL after
receiving at least two lines of therapy.
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This is an open label, single arm, phase II study to determine the efficacy, safety and PK (persistence) of MBCART2019.1 cells in adults with relapsed or refractory DLBCL after receiving at least two lines of therapy. Type: Interventional Start Date: May 2021 |
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent...
Symphogen A/S
Metastatic Cancer
Solid Tumor
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022,
Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC)
and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs)
per... expand
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations Type: Interventional Start Date: Oct 2020 |
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia...
Ionis Pharmaceuticals, Inc.
Familial Chylomicronemia Syndrome
The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on
the percent change in fasting triglycerides (TG) from baseline.
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The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline. Type: Interventional Start Date: Nov 2020 |
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who...
Incyte Corporation
Myelofibrosis
Primary Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis
Post Polycythemia Vera Myelofibrosis
The purpose of the study is to compare the efficacy and safety of parsaclisib when combined
with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis
who have suboptimal response while receiving ruxolitinib monotherapy.
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The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. Type: Interventional Start Date: May 2021 |
A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants...
Hoffmann-La Roche
Multiple Sclerosis, Primary Progressive
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in
adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible
participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or
intravenous (IV)... expand
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study. Type: Interventional Start Date: Oct 2020 |
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults...
Hoffmann-La Roche
Multiple Sclerosis
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose... expand
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab. Type: Interventional Start Date: Nov 2020 |
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 |
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 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
Alector Inc.
Frontotemporal Dementia
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001
in participants at risk for or with frontotemporal dementia due to heterozygous mutations in
the progranulin gene.
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A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. Type: Interventional Start Date: Jul 2020 |
JETi Peripheral Thrombectomy Registry
Abbott Medical Devices
Peripheral Artery Thrombosis
Venous Thrombosis
The JETi Registry is a prospective, multi-center, observational study to collect real-world
data on the safety, performance, and clinical benefits of the JETi® Peripheral Thrombectomy
System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral
vasculature.... expand
The JETi Registry is a prospective, multi-center, observational study to collect real-world data on the safety, performance, and clinical benefits of the JETi® Peripheral Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. Type: Observational [Patient Registry] Start Date: Mar 2020 |
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants...
Eli Lilly and Company
Type 2 Diabetes Mellitus
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide
in participants with type 2 diabetes and increased cardiovascular risk.
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The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. Type: Interventional Start Date: May 2020 |
A Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic...
Astellas Pharma Global Development, Inc.
Locally Advanced or Metastatic Malignant Solid Tumors
The primary purpose of this study is to determine the antitumor activity of enfortumab
vedotin as measured by confirmed objective response rate (ORR).
This study will also assess other measures of antitumor activity; overall survival (OS); as
well as the safety and tolerability... expand
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR). This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin. Type: Interventional Start Date: Mar 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 |
Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel)...
National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer AJCC v8
Hormone Receptor-Positive Breast Carcinoma
Metastatic Breast Carcinoma
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Neoplasm in the Bone
This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating
patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a
radioactive drug that behaves in a similar way to calcium and collects in cancer that has... expand
This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, 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. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone. Type: Interventional Start Date: Dec 2019 |
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 |
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel...
National Cancer Institute (NCI)
Endometrial Clear Cell Adenocarcinoma
Endometrial Dedifferentiated Carcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Mixed Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and
carboplatin works compared with paclitaxel and carboplatin alone in treating patients with
endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with
monoclonal... expand
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). 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. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer. Type: Interventional Start Date: Jul 2019 |
Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal...
Cardiff Oncology
Metastatic Colorectal Cancer
KRAS Gene Mutation
The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib,
administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with
FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic... expand
The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab. Type: Interventional Start Date: May 2019 |
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