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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).
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A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
A Study to 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.
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Donor-Derived Anti-CD33 CAR T Cell Therapy (VCAR33) in Patients With Relapsed or Refractory AML After...
Vor Biopharma
Leukemia, Myeloid, Acute
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived
anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed
or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched
allogeneic... expand
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (alloHCT). Type: Interventional Start Date: Dec 2023 |
A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the
treatment... expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening.
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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 Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic...
Beam Therapeutics Inc.
Lymphoblastic Lymphoma
T-Cell Lymphoblastic Leukemia/Lymphoma
Lymphoblastic Leukemia
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of
BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1
dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will... expand
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort. Type: Interventional Start Date: May 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:
-... 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 |
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous...
Bristol-Myers Squibb
Multiple Myeloma
The purpose of this study is to compare the effectiveness of iberdomide maintenance to
lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in
participants with newly diagnosed multiple myeloma (NDMM).
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The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM). Type: Interventional Start Date: Jun 2023 |
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
Respiratory Distress Syndrome, Acute
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of
GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after
ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first
dose... expand
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days. Type: Interventional Start Date: Apr 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants... 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 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Celldex Therapeutics
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients.
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The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine,...
Kura Oncology, Inc.
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Mixed Lineage Leukemia Gene Mutation
Mixed Phenotype Acute Leukemia
Refractory AML
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3
for two different molecularly-defined arms, NPM1-m and KMT2A-r.
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This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. Type: Interventional Start Date: Jul 2023 |
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Daiichi Sankyo
Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by
autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care
therapies used to treat SLE are only partially effective and have a wide range of toxicities.... expand
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care therapies used to treat SLE are only partially effective and have a wide range of toxicities. There is a need for more effective and safer therapies for patients with SLE. Type: Interventional Start Date: Jun 2023 |
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Eli Lilly and Company
Breast Neoplasms
The main purpose of this study is to measure how well imlunestrant works compared to standard
hormone therapy in participants with early breast cancer that is estrogen receptor positive
(ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken... expand
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Type: Interventional Start Date: Oct 2022 |
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter,
platform study to investigate efficacy, safety, and tolerability of various single treatments
in participants with idiopathic pulmonary fibrosis
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A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis Type: Interventional Start Date: Nov 2022 |
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Microvention-Terumo, Inc.
Intracranial Aneurysm
The objective of this study is to generate contemporaneous clinical data to facilitate a
reasonable comparison of the performance of the FRED™ X™ device with the performance of the
FRED™ device. The data generated from this study will be compared to the safety and
effectiveness... expand
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study. Type: Interventional Start Date: Sep 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 Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's...
Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and
safety of giredestrant plus everolimus compared with the physician's choice of endocrine
therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal
growth... expand
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting. 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,... 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 |
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Poseida Therapeutics, Inc.
Breast Cancer
Ovarian Cancer
Non Small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult
subjects with advanced or metastatic epithelial derived solid tumors, including but not
limited to the tumor types listed below.
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A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below. Type: Interventional Start Date: Feb 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 |
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Alliance for Clinical Trials in Oncology
Cigarette Smoking-Related Carcinoma
This phase III trial compares the effect of text-based cessation intervention to a manual in
helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may
reduce the frequency of cigarette use to zero and may be effective in quitting smoking.
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This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking. Type: Interventional Start Date: Apr 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 |
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 |
Obeticholic Acid for Prevention in Barrett's Esophagus
National Cancer Institute (NCI)
Barrett Esophagus
This phase II trial studies the effect of obeticholic acid in treating patients with
Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to
neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic,
anti-inflammatory... expand
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1β and TNFα in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression. Type: Interventional Start Date: Jan 2024 |
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