NCT03943264

A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's

Phase 1b Open-Label, Dose-Identification Study of XPro1595 in Patients With Alzheimer's Disease and Biomarkers of Inflammation.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Inmune Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and target engagement of XPro1595 in Alzheimer's patients with biomarkers of inflammation.

Detailed description

The study is designed as a multicentre, phase 1b open-label study. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with Alzheimer's disease and at least one of the following inflammatory biomarkers: high sensitivity c-reactive protein (hs-CRP), hemoglobin A1c, erythrocyte sedimentation rate (ESR), or one Apolipoprotein E4 allele. XPro1595 is a second-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF, an inflammatory factor implicated in Alzheimer's pathology. A key element of this study is to identify Alzheimer's patients that are most likely to benefit from XPro1595 treatment. Enrollment is limited to patients with evidence of inflammation. For instance, hs-CRP is an inflammatory biomarker elevated in the blood of some Alzheimer's patients and elevated CRP has been shown to predict response to TNF inhibitors in multiple other diseases. Alzheimer's patients with elevated inflammatory biomarkers will be enrolled in a 12-week study to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of invasive and non-invasive biomarkers of inflammation. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	XPro1595	XPro1595 will be delivered by subcutaneous injection once a week

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-06-30
• Completion: 2021-09-01
• First posted: 2019-05-09
• Last updated: 2023-06-15

Locations

5 sites across 1 country: Australia