A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT06752356 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: KB071
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 3

Brief Summary

The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; Intravenous; Human Immunoglobulin; KIg10; QIVIGY

Outcome Measures

Primary Outcomes (1)

• Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP

  The proportion of responders in the 1.0 g/kg KIg10 arm, at week 24 relative to Randomization Baseline week 0, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.

  From Baseline upto 24 weeks of treatment

Secondary Outcomes (9)

• Efficacy of 0.5 g/kg KIg10 in the treatment of adult subjects with active CIDP

  From Baseline upto 24 weeks of treatment

• Proportion of responders (Week 24 vs Baseline) in both dose groups

  From Baseline upto 24 weeks of treatment

• Proportion of responders in rescued subjects

  End of Treatment vs onset of rescue treatment

• Improvers based on the MRC-sumscore

  From Baseline upto 24 weeks of treatment

• Mean Change in MRC-sumscore

  From Baseline upto 24 weeks of treatment

Other Outcomes (2)

• Number of adverse events

  From Baseline upto 25 weeks

• The proportion of patients experiencing at least one adverse event.

  From Baseline upto 25 weeks

Study Arms (2)

1.0 g/kg dose group for 24 weeks

EXPERIMENTAL

This group will receive, initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion followed by 1.0 g/kg of IV KIg10 every 3 weeks.

Biological: Immune globulin (human) 10% solution for intravenous administration

0.5 g/kg dose group for 24 weeks

EXPERIMENTAL

This group will receive, Initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion will be given followed by 0.5 g/kg of IV KIg10 every 3 weeks.

Biological: Immune globulin (human) 10% solution for intravenous administration

Interventions

Immune globulin (human) 10% solution for intravenous administration BIOLOGICAL

Kedrion intravenous immunoglobulin (IVIg) 10%

Also known as: KIg10

0.5 g/kg dose group for 24 weeks; 1.0 g/kg dose group for 24 weeks

Eligibility Criteria

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

You may qualify if:

• Male or female, aged ≥18 years.
• Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
• Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria.
• Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.
• Participants are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.
• Weakness of at least two limbs.
• Participants should be clinically stable 12 weeks prior to screening date as defined by:
• without a worsening in INCAT score of ≥1 point, AND/OR without significant changes in clinical symptoms AND
• without significant dose changes or requiring additional treatments.

You may not qualify if:

• Patients' incapable of giving informed consent.
• Pure sensory and other CIDP variants.
• Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.
• IG-experienced participants requiring an IGIV dosage of more than 1.4 g/kg/month OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g/kg/month.
• Participants who have previously failed to respond to IGIV or SCIG.
• On screening date, a body mass index (BMI) \> 35 kg/m2 or an IGIV dose that puts the patient at risk of fluid overload.
• CIDP and any neuropathy of other causes not consistent with the 2021 EAN/PNS criteria including:
• Hereditary demyelinating neuropathies, such as a hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth \[CMT\] disease), and hereditary sensory and autonomic neuropathies (HSANs).
• Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexopathy or neuropathy, lymphoma, and amyloidosis.
• Multifocal motor neuropathy (MMN).
• Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. Peripheral neuropathy induced by vitamin B12 deficiency.
• Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with increased titers of antibodies to myelin-associated glycoprotein.
• Central demyelinating disorders (e.g, multiple sclerosis) or severe myopathy.
• Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (e.g., severe arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) \[participants with clinically diagnosed diabetes mellitus, who have adequate glycemic control with Hemoglobin A1C (HbA1C) of \<7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed\].
• Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension \[i.e., diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>160 mmHg\]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.

Sponsors & Collaborators

• Kedrion S.p.A.: lead

Study Sites (3)

USF Health - Morsani Center for Advanced Healthcare

Tampa, Florida, 33613, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Advanced Neurology Epilepsy and Sleep Center/ANESC Research

El Paso, Texas, 79912, United States

RECRUITING

Related Publications (1)

• Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.

  PMID: 18178525 BACKGROUND

Related Links

• Lewis et al. Chronic Inflammatory Demyelinating Polyneuropathy, National Organization for Rare Disorders, Updated 01Oct2024

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins; Solutions; Administration, Intravenous

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

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lakshmi Deshpande

  Kedrion S.p.A.

  STUDY CHAIR

Central Study Contacts

Anna Lotti Suffredini

CONTACT

+39 338 6827568; a.lotti@kedrion.com

Esra Cinar-Jones

CONTACT

+44 7551 563340; e.cinarjones@kedrion.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor will also be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blind, Randomized.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 30, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)