A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Nuvig Therapeutics
60 participants
Jun 28, 2025
Interventional
Conditions
Summary
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). A clinical trial to test a new drug, NVG-2089, in patients with CIDP
Eligibility
Inclusion Criteria9
- Diagnosis and disease characteristics
- Diagnosed with CIDP or Possible CIDP according to criteria of the EAN/PNS 2021 (Van den Bergh, 2021).
- Must have an adjusted INCAT score as follows:
- Treatment-naïve participants: greater or equal to 2 at screening
- Treatment-experienced participants: 2-7 at screening
- Note: A score of 2 should be exclusively from leg disability component of adjusted INCAT.
- Treatment-experienced participants: Participants who were treated with IVIg/SCIg at the time of screening must have documented evidence within 24 months of screening of : clinically meaningful deterioration on treatment interruption or dose reduction of standard of care (SOC) therapy OR improvement in CIDP with SOC
- Treatment-naïve participants: No prior treatment with IVIg and/or SCIg and/or corticosteroids and/or investigational therapies for CIDP.
- Treatment-experienced participants: On stable dose of IVIg or SCIg with no disease exacerbations for 8 weeks prior to screening. Participants must be willing to discontinue IVIg or SCIg at least 3 weeks (±1 week) prior to dosing with the study drug. Participants on IVIg must be on maintenance dose of 0.4 to 1 g/kg every 2 to 6 weeks per EAN/PNS recommendation. Participants on SCIg should not exceed the dose of 0.4 g/kg per week.
Exclusion Criteria8
- Pure sensory or distal CIDP variants (EAN/PNS definition).
- History of being non-responder or loss of response to IVIg or SCIg per Investigator’s determination. Note, participants who are on IVIg but relapsed on SCIg will be allowed to enter the study.
- Polyneuropathy of other causes.
- Any history of myelopathy or evidence of central demyelination.
- Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of CIDP.
- The following therapies are excluded:
- Within 3 months (or 5 half-lives of the drug, whichever is longer) before screening: plasma exchange or immunoadsorption, any Fc-containing therapeutic agents or other biological, or any other investigational or approved product for the treatment of CIDP.
- Within 6 months before screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, methotrexate, azathioprine, mycophenolate, any other immunomodulating or immunosuppressive medications
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
NVG-2089 is a recombinant human immunoglobulin G1(IgG1) Fc-domain homodimer that contains a single point mutation (F241A) which confers the ability to bind and activate the immunomodulatory type 2 Fc receptors. The Fc-domain is further modified to contain higher levels of 2,6 sialylation at Asn297, conferring a pharmacokinetic (PK) advantage (e.g., longer half-life) in mice which is expected to translate to humans. - 150 mg/kg every 2 weeks - 7 doses administered within 12 weeks - Intravenous Infusion To monitor adherence to the intervention the infusions will be supervised by study staff.
Locations(9)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12625000534482