Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

NCT ID: NCT02556437

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-05-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).

Detailed Description

Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous immunoglobulin (IGIV), may be self-induced and may induce fewer systemic adverse reactions. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. This is an issue in particular in MMN where relatively high and frequent doses are necessary to maintain long-term improvement of muscle strength. Recombinant human hyaluronidase (rHuPH20) increases subcutaneous tissue permeability and facilitates dispersion and absorption, enabling subcutaneous administration of higher (monthly) doses of Ig. If treatment with HyQvia is at least equally effective and safe as compared with conventional Ig treatment, HyQvia could become the preferred treatment option for patients with MMN as it may have attractive benefits for patients by its mode of administration.

Conditions

Multifocal Motor Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia

Group Type: EXPERIMENTAL

HyQvia

Intervention Type: DRUG

Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection

Subcuvia

Intervention Type: DRUG

Human immunoglobulin 16% for subcutaneous injection

Group B

24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)

Group Type: EXPERIMENTAL

HyQvia

Intervention Type: DRUG

Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection

Subcuvia

Intervention Type: DRUG

Human immunoglobulin 16% for subcutaneous injection

Interventions

HyQvia

Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection

Intervention Type: DRUG

Subcuvia

Human immunoglobulin 16% for subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Human immunoglobulin; Human immunoglobulin

Eligibility Criteria

Inclusion Criteria

• Age at onset 18 - 65 years.
• The presence of asymmetrical limb weakness at onset or motor involvement having a motor nerve distribution in at least two peripheral nerve distributions, predominant upper limb involvement, disabling weakness MRC grade 4 or less in at least one muscle.
• Decreased or absent tendon reflexes in affected limbs.
• Electrophysiological evidence of one site with definite motor conduction block or one site with probable conduction block according to previously defined criteria.
• Response to SCIG according to criteria that were described in previous studies
• On SCIG maintenance treatment for more than 3 months preceding the study.
• Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.

Exclusion Criteria

• Bulbar signs or symptoms.
• Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response).
• Sensory symptoms and signs with sensory deficits on examination (except for vibration sense) and abnormal results of sensory nerve conduction studies
• Other neuropathies (e.g. diabetic, lead, porphyric or vasculitic neuropathy, chronic inflammatory demyelinating polyneuropathy, Lyme neuroborreliosis, post radiation neuropathy, hereditary neuropathy with liability to pressure palsies, Charcot-Marie-Tooth neuropathies, meningeal carcinomatosis).
• Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporin) in the 6 months preceding the study.
• Female patient who is pregnant or breast-feeding or of childbearing potential.
• Confirmation that the patient is not pregnant will be established by a negative b-HCG test within a 7-day period before inclusion in the study. Lack of childbearing potential is met by a) being post-menopausal, b) being surgically sterile, c) practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermicide or d) being sexually inactive.
• Age < 18 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Johannes Jakobsen

OTHER

Sponsor Role: lead

Responsible Party

Johannes Jakobsen

Professor, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johannes Jakobsen, DMSc

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Center, Rigshospitalet

Locations

Department of Neurology, Aarhus University Hospital

Aarhus C, , Denmark

Department of Neurology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

RH-2015-200

Identifier Type: -

Identifier Source: org_study_id