An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naive Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies
Latest Information Update: 06 Mar 2025
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At a glance
- Drugs Idursulfase (Primary) ; Immune globulin (Primary) ; Methotrexate (Primary) ; Rituximab (Primary)
- Indications Mucopolysaccharidosis II
- Focus Pharmacodynamics
- Sponsors Takeda
- 11 Dec 2024 Planned End Date changed from 15 Jun 2027 to 17 Jul 2028.
- 11 Dec 2024 Planned primary completion date changed from 15 Jun 2027 to 17 Jul 2028.
- 21 Sep 2023 Planned End Date changed from 9 Sep 2026 to 15 Jun 2027.