None listed
Conditions
Brief 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
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
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.
Sponsors
Nuvig Therapeutics
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed