NCT05494593 - A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

July 17, 2028

Study Completion Date

July 17, 2028

Conditions

Mucopolysaccharidosis (MPS)Hunter Syndrome

Interventions

DRUG

ELAPRASE

Participants will receive 0.5 milligram per kilogram (mg/kg) of body weight of ELAPRASE, intravenous, infusion for 104 weeks.

DRUG

Rituximab

Participants will receive 375 milligram per square meter per dose (mg/m\^2/dose) of intravenous rituximab weekly for 4 weeks in 5-week cycle.

DRUG

Methotrexate

Participants will receive 0.4 mg/kg of methotrexate by mouth (PO) 3 times per week for 5 weeks in each cycle.

DRUG

Intravenous Immunoglobulin (IVIG)

Participants will receive 500 mg/kg of IVIG every 4 weeks in 5-week cycle.

Trial Locations (8)

10032

RECRUITING

NewYork-Presbyterian Morgan Stanley Children's Hospital, New York

44087

RECRUITING

The Cleveland Clinic Foundation, Twinsburg

55404

RECRUITING

Children's Hospitals and Clinics of Minnesota, Minneapolis

60611

RECRUITING

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

90502

RECRUITING

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center, Torrance

92123

RECRUITING

Rady Childrens Hospital San Diego - PIN, San Diego

94609

RECRUITING

Children's Hospital and Research Center at Oakland, Oakland