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Idursulfase

Phase 2

Hunter Syndrome | Monoclonal antibody | Rare Disease |Takeda Pharmaceutical Company Limited|Last Updated: Jun 10, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

Idursulfase · 1 trial · 2 indications

Phase 2 1
NCT00630747Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving IdursulfaseHunter Syndrome
COMPLETED94 Analytics
PHASE2COMPLETED
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Hunter Syndrome
NCT0063074794
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Study Endpoints

Primary Endpoints

Change From Baseline in Mean Percent Predicted Forced Vital Capacity (FVC) at Week 105
Baseline and at Week 105

Determined by spirometry. The change is calculated as Week 105 minus baseline.

Change From Baseline in Mean Distance Walked in the 6-minute Walk Test (6MWT) at Week 105
Baseline and at Week 105

Determined on a walking course. The change was calculated as Week 105 minus baseline.

Secondary Endpoints

Change From Baseline in Mean Passive Joint Range of Motion (JROM) at Week 105
Baseline and at Week 105
Change From Baseline in Mean Combined Liver and Spleen Volume at Week 105
Baseline and at Week 105
Change From Baseline in Mean Normalized Urine Glycosaminoglycans (GAG) Levels at Week 105
Baseline and at Week 105
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IdursulfaseEXPERIMENTAL -

Interventions

NameTypeDescription
IdursulfaseBIOLOGICALSolution for intravenous infusion, 0.5 mg/kg once-weekly
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Eligibility Criteria

Age Range5 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Patient must have completed the double-blind phase of Study TKT024, defined as completing the Week 53 final evaluations. * Patient, patient's parent(s), or legally authorized representative must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Com...

Countries:United StatesBrazilCanadaFranceGermanyItalyRomaniaSpainSwedenUnited Kingdom
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Frequently asked questions about Idursulfase

What is Idursulfase used for?

Idursulfase is used for Hunter Syndrome, also known as Mucopolysaccharidosis II (MPS II). It is an investigational therapy being studied in patients with this rare genetic disorder. The drug is currently in Phase 2 clinical development and is not approved for commercial use.

Who makes Idursulfase?

Idursulfase is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical research on this drug for the treatment of Hunter Syndrome, a rare disease.

What phase is Idursulfase in?

Idursulfase is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the drug is still being studied for its safety and efficacy in patients with Hunter Syndrome.

What clinical trials is Idursulfase in?

Idursulfase has one completed clinical trial registered under NCT00630747. This trial was an extension study evaluating long-term safety and clinical outcomes in patients with Hunter Syndrome receiving idursulfase. The study enrolled 94 male participants aged 5 years and older across multiple countries.

Is Idursulfase the same as Elaprase?

Idursulfase is the generic name for the drug also known as Elaprase. It is being studied for the treatment of Hunter Syndrome, a rare lysosomal storage disorder. The drug is currently in Phase 2 clinical development and is not yet approved.