Louisville, Kentucky Clinical Trials

S Sade Andrews

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic …

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double …

H Hannah College

A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. …

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

The primary objective of this study is to determine the effects of KAI-9531 administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form. The study is focused on participants …

Registry for Stage 2 Type 1 Diabetes

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 …

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled …

Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to …