Joint Clinical Trials Office

CT Open to Enrollment

EoE-201, A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adult Subjects with Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20mg to Evaluate the Safety and Efficacy of Vonoprazan 20mg Compared to Placebo

This clinical research study aims to investigate the safety and efficacy of a study drug called vonoprazan, a potassium-competitive acid blocker, for treating Eosinophilic Esophagitis (EoE). EoE is characterized by an excessive presence of eosinophils in the esophagus, leading to inflammation and symptoms such as difficulty swallowing, chest pain, and nausea. The main objective of the study is to assess the effectiveness of vonoprazan in alleviating the symptoms of EoE and improving patient outcomes.

A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer

The purpose of this study is to evaluate the safety and effectiveness of AAA817 and an Androgen receptor pathway inhibitor (ARPI) given compared to the standard of care options.
   
AAA817 is experimental, which means it is being tested and is not yet approved by the United States Food and Drug Administration (FDA).
   
In this study, AAA817 will be given intravenously (meaning through a needle in the vein directly into the blood). The Androgen receptor pathway inhibitor (ARPI) will be given orallly.

The underappreciated role of atherosclerotic cardiovascular disease in primary biliary cholangitis

This project hopes to learn about the impact of high cholesterol in patients with primary biliary cholangitis. Participants wil have primary biliary cholangitis and elevated cholesterol levels.

Primary biliary cholangitis is a chronic, cholestatic liver disease that results in progressive fibrosis and ultimately cirrhosis 

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged AML

The purpose of this study is to evaluate the safety and effectiveness of Ziftomenib (KO-539) in patients with acute myeloid leukemia (AML). This study has 2 separate investigations (Nonintensive and Intensive). 

A Phase III, Multisite, Double-Blinded Randomized Trial of BNT327 In Combination with Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab In Combination with Chemotherapy In Participants with First-Line Extensive-Stage Small-Cell Lung Cancer

This clinical trial is for adults who have extensive stage small cell lung cancer (ES-SCLC) for which they have received no treatment.
   
The purpose of this study is to evaluate the effects of BNT327 (the “study drug”) when combined with chemotherapy (etoposide plus carboplatin), compared with standard of care, a drug called atezolizumab in combination with chemotherapy (etoposide plus carboplatin), to find out the following:
   

FMT and Other Gut Microbial Therapies National Registry: Acute Severe and Fulminant C. Difficile Infection

This registry study is being done to collect information on fecal microbiota transplantation (FMT) and other gut microbial therapies (GMTs). Participants in this research study will have been given an FMT, or other GMT. FMTs and other GMTs are standard medical care used to treat patients who have recurrent Clostridioides difficile infection.
   

GS-US-567-6968: Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

This study is for men and women who have been diagnosed chronic hepatitis delta (Hep D). This study will test the experimental/investigational drug GS-4321.

Prospective randomized study of the Kono-S anastomosis versus the side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn’s disease

The purpose of this study is to compare the post-operative recurrence of Crohn’s disease (the return of the disease after surgery) and the surgical recurrence (additional surgery after the initial one) between the Kono- S procedure and the side-to-side functional end anastomosis.

Development of RPBM for Quantitative Assessment of Myofascial Pain

The purpose of this study is to develop MRI methods for more accurate evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome (MMPS).

Study participation involves one 60-minute non-contrast MRI of the jaw. There is also an optional repeat MRI.

Participants will also complete a questionnaire (about 10-15 minutes) that has questions on topics including jaw pain and sleep quality any time prior to the MRI. 

Study participants will be compensated $100 for completing the study.

A Phase 3 randomized open-label study of belantamab mafodotin in combination with lenalidomide and dexamethasone versus daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma who are ineligible for auto-SCT

The goal of this clinical trial is to compare the safety and efficacy of belantamab mafodotin combinated with lenalidomide and dexamethasone to the combination of daratumumab, lenalidomide and dexamethasone in participants who have newly diagnosed multiple myeloma and are not eligible for autologous stem cell transplantation. The study also wants to determihne if the study drug is safer and works better than the current standard of care treatment.