An Open Label Study of ANX005 in Subjects With, or at Risk for, Manifest Huntington's Disease

Completed · Phase 2

Conditions studied: Huntington Disease

In brief

This study is a multi-center, open-label study of intravenous (IV) ANX005 in subjects with, or at risk for, manifest Huntington's Disease (HD).

Key facts

Study ID

NCT04514367

Run by

Annexon, Inc.

People needed

28

Starts

2020-08-17

Expected to finish

2022-01-28

Last updated by the study team

2023-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of or at risk for Huntington's disease: Genetically confirmed disease by direct DNA testing, total CAG-Age Product (CAP) score > 400 and UHDRS independence score ≥ 80.
• Able to walk independently and self-sufficient in basic activities of daily living (e.g. eating, dressing, bathing).
• All HD concomitant medications stable.
• If female, must be postmenopausal (no menses for at least 2 years without an alternative medical cause), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or agree to use highly effective methods of contraception.
• Males with a woman of childbearing potential partner must agree to use highly effective methods of contraception.
• Previously vaccinated against encapsulated bacterial pathogens (Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae) or willing to undergo vaccination.
• Able to tolerate EEG and lumbar puncture (LP) procedures.

You may not qualify if…

• Be at risk of suicide or self-harm within the preceding 12 months.
• Chorea and/or cognitive deficits severe enough to interfere with study assessments.
• Subjects with body weight > 150 kg.
• Clinically significant findings on the screening laboratory testing or physical examination that are not specific to HD and may interfere with the conduct of the study or the interpretation of the data or increase subject risk.
• Signs and symptoms of, or a diagnosis consistent with a chronic autoimmune disorder and/or an ANA titer ≥ 1:160.
• History of previous infusion reactions, sensitivities, allergic, or anaphylactic reactions to previous medications, environmental stimuli or other substances.
• Use of an experimental agent within 60 days or five half-lives prior to Screening or anytime over the duration of this study.
• Prior treatment with any monoclonal antibody.
• Presence of an implanted deep brain stimulation device.
• Any history of gene therapy, RNA or DNA targeted HD specific investigational agents such as antisense oligonucleotides, cell transplantation or any experimental brain surgery.
• Brain and spinal pathology that may interfere with cerebrospinal fluid homeostasis and circulation, increases intracranial pressure (implanted shunt or catheter), malformations or tumor.
• Contraindication to undergoing an LP.
• Hypersensitivity to any of the excipients in the ANX005 drug product.
• Clinically significant intercurrent illness, medical condition, or medical history (including neurological or mental illness, HIV, any active infection, including Hepatitis B or C) that would jeopardize the safety of the subject, limit participation, or compromise the interpretation of the data derived from the subject.
• Any known genetic deficiencies of the complement-cascade system.
• History of chronic oral or intravenous steroid use or immunosuppressant medication use.
• Hemoglobin, bilirubin, or lactate dehydrogenase (LDH) values that are outside normal limits and clinically significant or suggestive of hemolytic anemia.

Where it is running

• Annexon Investigational Site 02 — Birmingham, Alabama, United States
• Annexon Investigational Site 03 — Englewood, Colorado, United States
• Annexon Investigational Site 04 — Washington D.C., District of Columbia, United States
• Annexon Investigational Site 07 — Durham, North Carolina, United States
• Annexon Investigational Site 06 — Cincinnati, Ohio, United States
• Annexon Investigational Site 08 — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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