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Trial registered on ANZCTR


Registration number
ACTRN12625000534482
Ethics application status
Approved
Date submitted
25/04/2025
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
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)
Secondary ID [1] 314250 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Demyelinating Polyneuropathy 337173 0
Condition category
Condition code
Neurological 333588 333588 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330861 0
Treatment: Drugs
Comparator / control treatment
No control group - Open Label Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341178 0
To evaluate the safety of NVG-2089 in participants with CIDP
Timepoint [1] 341178 0
Adverse event data will be collected evert 2 weeks, until 20 weeks post-first dose
Primary outcome [2] 341398 0
To evaluate the tolerability of NVG-2089 in participants with CIDP
Timepoint [2] 341398 0
Adverse event and laboratory data will be collected every 2 weeks, until 20 weeks post-first dose.
Secondary outcome [1] 447788 0
Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is define as improvement of 4 points on Inflammatory Rasch-built Overall Disability Scale (I-RODS).
Timepoint [1] 447788 0
Data will be collected every 2 weeks until 20 weeks post-first dose.
Secondary outcome [2] 447387 0
Treatment-experienced Participants: • Percentage of participants who meet any of the following conditions: - Achieving ECI at Week 14 - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14 Worsening is defined as an increase in the adjusted INCAT score of at least 1 point. A worsening by 1 point requires confirmation within 1 week; no confirmation is required for a worsening that is at least 2 points. • Percentage of participants who meet any of the following conditions: - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14 • Percentage of participants with ECI at Week 14
Timepoint [2] 447387 0
Data will be collected every 2 weeks until 20 weeks post-first dose.
Secondary outcome [3] 446661 0
To evaluate the efficacy of NVG-2089 in participants with CIDP
Timepoint [3] 446661 0
Week 14 post-first dose
Secondary outcome [4] 447793 0
Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is define as improvement of 8 kilopascal (kPa) on mean grip strength (dominant hand). Grip strength will be assessed hand dynamometer
Timepoint [4] 447793 0
Week 14 post-first dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2025
Actual
Date of last participant enrolment
Anticipated
26/12/2026
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 26999 0
Serbia and Montenegro
State/province [1] 26999 0
Country [2] 26998 0
Spain
State/province [2] 26998 0
Country [3] 26994 0
Belgium
State/province [3] 26994 0
Country [4] 26997 0
Poland
State/province [4] 26997 0
Country [5] 27001 0
Taiwan, Province Of China
State/province [5] 27001 0
Country [6] 26996 0
Italy
State/province [6] 26996 0
Country [7] 27000 0
Canada
State/province [7] 27000 0
Country [8] 26995 0
Bulgaria
State/province [8] 26995 0
Country [9] 27002 0
United States of America
State/province [9] 27002 0

Funding & Sponsors
Funding source category [1] 318773 0
Commercial sector/Industry
Name [1] 318773 0
Nuvig Therapeutics
Country [1] 318773 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nuvig Therapeutics
Address
Country
United States of America
Secondary sponsor category [1] 321211 0
None
Name [1] 321211 0
Address [1] 321211 0
Country [1] 321211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317382 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 317382 0
Ethics committee country [1] 317382 0
Australia
Date submitted for ethics approval [1] 317382 0
18/11/2024
Approval date [1] 317382 0
21/02/2025
Ethics approval number [1] 317382 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140874 0
Dr Judith Spies
Address 140874 0
University of Sydney, Brain and Mind Centre, 94 Mallett street, Camperdown, New South Wales 2050
Country 140874 0
Australia
Phone 140874 0
+61293510704
Fax 140874 0
Email 140874 0
[email protected]
Contact person for public queries
Name 140875 0
Bella Oguno
Address 140875 0
Nuvig Therapeutics, 4200 Bohannon Drive, suite 250, Menlo Park 94025
Country 140875 0
United States of America
Phone 140875 0
+1 6503943990
Fax 140875 0
Email 140875 0
[email protected]
Contact person for scientific queries
Name 140876 0
Bella Oguno
Address 140876 0
Nuvig Therapeutics, 4200 Bohannon Drive, suite 250, Menlo Park 94025
Country 140876 0
United States of America
Phone 140876 0
+1 6503943990
Fax 140876 0
Email 140876 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.