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HyQvia

Phase 2

Multifocal Motor Neuropathy | Small molecule | Neurology |Baxter International Inc.|Last Updated: May 17, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

HyQvia · 1 trial · 1 indication

Phase 2 1
NCT02556437Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)Multifocal Motor Neuropathy
COMPLETED18 Analytics
PHASE2COMPLETED
Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)
Multifocal Motor NeuropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in isometric muscle strength
Evaluation at week 0, 12, 24, 36, 48

Measurement of isometric muscle strength of four involved muscle groups

Secondary Endpoints

Changes in disability score
Evaluation at week 0, 12, 24, 36, 48
Changes in clinical evaluation of muscle strength
Evaluation at week 0, 12, 24, 36, 48
Development of Headache and Nausea
During the entire study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia
Group BEXPERIMENTAL24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)

Interventions

NameTypeDescription
HyQviaDRUGHuman immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
SubcuviaDRUGHuman immunoglobulin 16% for subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 m...

Countries:Denmark
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Frequently asked questions about HyQvia

What is HyQvia used for in Multifocal Motor Neuropathy?

HyQvia is an investigational therapy being studied for the treatment of Multifocal Motor Neuropathy (MMN), a neurological condition. It is a small molecule developed by Baxter International Inc. (NYSE: BAX). HyQvia is currently in Phase 2 clinical development for this indication.

What does HyQvia target?

HyQvia is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its efficacy and safety in patients with Multifocal Motor Neuropathy (MMN), a condition affecting motor nerves.

Who makes HyQvia?

HyQvia is developed by Baxter International Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical research to evaluate HyQvia as a potential treatment for Multifocal Motor Neuropathy.

What phase is HyQvia in?

HyQvia is in Phase 2 clinical development for Multifocal Motor Neuropathy. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is HyQvia in?

HyQvia has been studied in one completed Phase 2 clinical trial, identified as NCT02556437. This trial, titled 'Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)', enrolled 18 participants in Denmark and was a controlled, randomized study.

Is HyQvia the same as Immunoglobulin 10% with Recombinant Hyaluronidase?

HyQvia is also known as Immunoglobulin 10% with Recombinant Hyaluronidase, as referenced in clinical trial NCT02556437. This name describes its composition, which includes immunoglobulin and recombinant hyaluronidase, and it is being investigated for Multifocal Motor Neuropathy.