An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease

NCT05522387 | Terminated Phase 2 DMC

• 1 other identifier: XPro1595-AD-OLE
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this Phase 2 Open Label study is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with Alzheimer's Disease.

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Keywords

Inflammation; Biomarker; Tumor Necrosis Factor (TNF)

Outcome Measures

Primary Outcomes (1)

• Number of participants who experience adverse events and serious adverse events

  Change from Baseline to Weeks 55, or 74 in the OLE Study Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram (ECG) findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.

  Weeks 55, or 74 in the OLE Study

Secondary Outcomes (9)

• To evaluate the change in cognitive performance following administration of open-label XPro1595

  Week 55 in the OLE Study

• To evaluate the change in cognition and global function following administration of open-label XPro1595

  Week 55 in the OLE Study

• To evaluate the change in non-cognitive behavioral symptoms following open-label administration of XPro1595

  Week 55 in the OLE Study

• To evaluate the change Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS- MCI- ADL)

  Week 55 in the OLE Study

• To evaluate the change on blood inflammatory and neurodegeneration biomarkers following open-label administration of XPro1595 (on blood inflammatory and neurodegeneration biomarker amyloid)

  Weeks 55, or 74 in the OLE Study

Study Arms (1)

Experimental: 1.0 mg/kg XPro1595

EXPERIMENTAL

Patients will receive XPro1595.

Drug: XPro1595

Interventions

XPro1595 DRUG

Each enrolled patient will be treated with 1.0 mg/kg of XPro1595 as a subcutaneous injection once a week for 55, or 74 weeks, for a total exposure to XPro1595 of up to 78 weeks (18 months), depending on their previous study.

Also known as: INB03/XPro™, XENP1595, DN-TNF

Experimental: 1.0 mg/kg XPro1595

Eligibility Criteria

• Age: 55 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if all the following criteria apply:
• Participated and completed the full duration of the study intervention and all procedures at the End of Study (EOS) visit in a previous XPro1595 study.
• Concomitant medications for the management of MCI/AD and/or behavior symptoms which were ongoing during the double-blind study should remain at a constant dose throughout this study.
• Patient must be willing and able to provide informed consent prior to any study procedures being performed. If the patient is not competent, a LAR (Legally Authorized Representative) must provide informed consent on their behalf, and the patient must provide assent.
• Has a study partner willing to participate for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which informant assessments are performed. This study partner should agree to monitor and report on concomitant medications, understand the study requirements, and assist the participant in meeting study requirements. Patients with study partners that do not meet this criterion but are determined by the investigator as able to provide an adequate assessment of the patient may also participate with prior approval from the sponsor (However, this is not a requirement for patients coming from the AD-02 PK Lead-In Study).
• All male subjects who are sexually active with a female of childbearing potential (FCBP) must agree to use a highly effective method of contraception during the treatment period and until 90 days after the last dose of treatment.
• All females of childbearing potential (FCBP) must have a negative urine pregnancy test and agree to use a highly effective method of contraception during the treatment period and 30 days after the last dose of treatment.

You may not qualify if:

• Any clinically significant abnormalities that in the opinion of the Investigator require further investigation or treatment or may interfere with study procedures and assessments or affect patient safety. These include but are not limited to, laboratory tests, electrocardiogram (ECG), physical examination, or vital signs at Screening or other medical conditions (e.g., cardiac, respiratory, gastrointestinal, psychiatric, renal disease) which are not adequately and stably controlled.
• Unable to comply with the study procedures and assessments.

Sponsors & Collaborators

• Inmune Bio, Inc.: lead

Study Sites (4)

KaRa MINDS

Macquarie Park, New South Wales, 2113, Australia

Location

Neuro Trials Victoria Pty Ltd T/A NeuroCentrix

Carlton, Victoria, 3053, Australia

Location

Austin Health

Ivanhoe, Victoria, 3079, Australia

Location

Australian Alzheimer's Research Foundation

Perth, Western Australia, 6009, Australia

Location

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Related Links

• Alzheimer's Association annual report releasing statistics regarding Alzheimer's disease

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Inflammation

Interventions

XENP 1595

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tara Lehner

  INmune Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An Open-Label Extension of XPro1595 in Patients with Alzheimer's Disease (AD) That Have Completed a Phase 2 Study with XPro1595

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 31, 2022
• Study Start: February 21, 2023
• Primary Completion: June 5, 2024
• Study Completion: July 5, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)