Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP

NCT07027111 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NVG-2089-2012024-515386-34-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with CIDP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to potentially help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• Evaluate incidence, nature and severity of TEAE's

  Week 14

• Evaluate incidence, nature and severity of SAE's

  Week 14

Secondary Outcomes (1)

• Evaluate the efficacy of NVG-2089 in participants with CIDP

  Week 14

Study Arms (2)

Treatment Experienced

EXPERIMENTAL

Drug: NVG-2089

Treatment Naive

EXPERIMENTAL

Drug: NVG-2089

Interventions

NVG-2089 DRUG

Study drug

Treatment Experienced; Treatment Naive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years of age at the time of signing the ICF.
• Diagnosed with CIDP or Possible CIDP according to criteria of the EAN/PNS 2021 (Van den Bergh, 2021). (Diagnosis is to be confirmed by an independent adjudication committee; refer to Section 8.1.1).
• Must have an adjusted INCAT score as follows:
• Treatment-naïve participants: ≥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. For participants with an adjusted INCAT score of ≥3 (and up to 7 for treatment-experienced; no upper limit for treatment-naïve) at study entry, there are no specific requirements for arm or leg scores.
• 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, determined by clinical examination documented in the medical records. Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in I-RODS total score ≥4 points, decrease in MRC Sum score ≥3, grip strength worsening of ≥8 kPa (in either hand), or an equivalent deterioration based on information from medical records and at the investigator's judgement.
• Improvement in CIDP symptoms with SOC therapy based on information in medical records and at the investigator's judgement. In assessing the history of response to IVIg/SCIg, the investigator should account for prior treatment (type, dose regimen, duration), pattern of response or non-response to treatment.
• a. Treatment-naïve participants: No prior treatment with IVIg and/or SCIg and/or corticosteroids and/or investigational therapies for CIDP.
• OR b. 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.

You may not qualify if:

• 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. In assessing the history of response or loss of response to IVIg/SCIg, the investigator should account for prior treatment (type, dose regimen, duration), pattern of response or non-response to treatment. Note, participants who are on IVIg but relapsed on SCIg will be allowed to enter the study.
• Polyneuropathy of other causes, including the following: multifocal motor neuropathy; polyneuropathy associated with anti-myelin associated glycoprotein (MAG) antibodies, polyneuropathy associated with IgM monoclonal gammopathy; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (POEMS); lumbosacral radiculoplexus neuropathy; polyneuropathy most likely due to diabetes mellitus; polyneuropathy most likely due to systemic illnesses; drug- or toxin-induced polyneuropathy.
• Acute demyelinating neuropathies including Guillain-Barre syndrome.
• Any other disease that could better explain the participant's signs and symptoms.
• 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.
• Severe psychiatric disorder (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the study protocol.

Sponsors & Collaborators

• Nuvig Therapeutics, Inc.: lead

Study Sites (1)

Nuvig Site

Denton, Texas, 76208, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 18, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)