RECRUITING

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2025-04-25

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07027111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: 1. Treatment-naïve participants: ≥2 at screening 2. 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: 1. 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. 2. 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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:
1. Treatment-naïve participants: ≥2 at screening
2. 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:
1. 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.
2. 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.

* 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.

Contacts and Locations

Study Contact

Nuvig Clinical Trials

CONTACT

650 292-2184

clinicaltrials@nuvigtx.com

Study Locations (Sites)

Nuvig Site

Denton, Texas, 76208

United States

Collaborators and Investigators

Sponsor: Nuvig Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-25

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-04-25

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Chronic Inflammatory Demyelinating Polyneuropathy