A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

NCT04626921 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CNMAu8.201LTE
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

Brief Summary

Open-label, long-term extension study available to participants who have completed CNMAu8.201.

Conditions

Relapsing Multiple Sclerosis

Keywords

MS; RMS; Multiple Sclerosis; Demyelination; Remyelination; Optic Neuropathy; Optic Neuritis; Gold; Nanocrystal; Multifocal VEP; Full Field VEP; Low contrast letter acuity

Outcome Measures

Primary Outcomes (2)

• Change in Best-Corrected Low-Contrast Letter Acuity score.

  Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.

  2 years

• Incidence of treatment-emergent AEs throughout the study.

  Safety endpoint include incidence of treatment-emergent AEs.

  2 years

Secondary Outcomes (1)

• Measure of neurological function assessed by a functional composite responder analysis.

  2 years

Other Outcomes (23)

• Change in best corrected Low-Contrast Letter Acuity score for total number of correct letter.

  2 years

• Change in Best Corrected High Contrast Visual Acuity

  2 years

• VEP latency for Multi-Focal visual evoked potential.

  2 years

Study Arms (1)

Active treatment with 30 mg of CNM-Au8

EXPERIMENTAL

Highly pure elemental Au nanocrystals are suspended in deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) concentrated up to 0.5 mg/mL (500 ppm) Au.

Drug: CNM-Au8

Interventions

CNM-Au8 DRUG

30 mg of CNM-Au8

Active treatment with 30 mg of CNM-Au8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have completed study CNMAu8.201.
• Able to understand and give written informed consent.

You may not qualify if:

• Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS) study.
• Positive pregnancy test.
• Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins.
• Based on the Investigator's judgment, any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the participant, or lead to difficulty complying with the protocol; any untreated or unstable psychiatric disease including depression, bipolar and psychosis.
• Participant is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
• Following clinical and serology sample analysis conducted at the end-of-study visit for CNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension study if any of the following criteria are met, at the discretion of the Medical Monitor and/or Sponsor's Medical Representative:
• Positive serology for viral hepatitis B and/or C and/or human immunodeficiency virus (HIV).
• Abnormal liver function tests (aspartate aminotransferase \[ASAT\] or alanine aminotransferase \[ALAT\] \> 2x upper limit of normal range (ULN) or total bilirubin \> 2x ULN or alkaline phosphatase (AP) \> 3x ULN).
• Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function (e.g., glomerular filtration rate \< 40 mL/min \[based on creatinine clearance according to Cockcroft-Gault equation\]), or those with low platelet counts (\<150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils per microliter) at the EOS visit for CNMAu8.201 (Visionary-MS).

Sponsors & Collaborators

• Clene Nanomedicine: lead
• George Clinical: collaborator

Study Sites (5)

Sydney Brain Mind Centre

Camperdown, New South Wales, 2050, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Menzies Institute for Medical Research

Hobart, TAZ, 7000, Australia

Location

The Alfred Centre Department of Neuroscience

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases; Optic Nerve Diseases; Optic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None, open-label.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Long-Term Extension.

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 13, 2020
• Study Start: October 22, 2020
• Primary Completion: May 29, 2023
• Study Completion: September 6, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)