This study is a multicenter, Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of RHB-104 compared to placebo to treat subjects with moderate to severe CD. RHB-104 consists of 3 antibiotics with activity against Mycobacterium avium subsp. paratuberculosis (MAP), a potential cause of CD. Subjects with active CD will be randomized at baseline in a 1:1 fashion to receive up to 52 weeks of RHB-104 or placebo.

DESCRIPTION: TRIM5? restriction factors bind retroviral capsids after cell entry and restrict retroviral infection by blocking reverse transcription and/or integration of the viral genetic material. The C-terminal SPRY domain of TRIM5? is believed to form most of the capsid-TRIM5? interface as species-specific sequence variations within the SPRY domain account for differences in the viral specificity of the TRIM5?-mediated restriction. Most notably, recent evolution of the human TRIM5?

The goal of this trial is to compare if and for how long trastuzumab combined with either NeuVax (nelipepimut-S given with GM-CSF [sargramostim]) or sargramostim can help control the disease in patients with HER2 positive breast cancer. NeuVax is not FDA approved or commercially available. It is currently being used for research purposes only. Sargramostim is FDA approved and commercially available to help raise patients’ white blood cell counts after chemotherapy. Giving NeuVax or sargramostim to patients with HER2-positive breast cancer is investigational.

This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real life clinical setting

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.

The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men with high-risk non-metastatic castration-resistant prostate cancer.

RESEARCH

RESEARCH