Hunter syndrome study pulled before it even started

NCT ID NCT05494593

Terminated Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if giving a combination of immune-suppressing drugs (rituximab, methotrexate, and IVIG) alongside the standard enzyme therapy ELAPRASE could prevent patients with Hunter syndrome from developing harmful antibodies. It was designed for boys who had never received ELAPRASE before. However, the study was withdrawn by the sponsor before enrolling any participants, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Idursulfase (ELAPRASE), rituximab, methotrexate, intravenous immunoglobulin
What this could lead to: If successful, this approach could help prevent the body from rejecting enzyme replacement therapy, making treatment more effective for Hunter syndrome patients.
What could go wrong: The study was withdrawn before enrolling any participants, so no results are available. The immune tolerizing regimen adds significant medication and potential side effects without proven benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

mucopolysaccharidosis mucopolysaccharidosis type 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HUNTER SYNDROME MUCOPOLYSACCHARIDOSIS (MPS)

Contacts and locations

Locations

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States
Children's Hospital and Research Center at Oakland

Oakland, California, 94609, United States
Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States
NewYork-Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States
Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States
Rady Childrens Hospital San Diego - PIN

San Diego, California, 92123, United States
The Cleveland Clinic Foundation

Twinsburg, Ohio, 44087, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

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