Trials / Active Not Recruiting
Active Not RecruitingNCT04573023
A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- JCR Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JR-141 | IV infusion, 2.0 mg/kg/week |
| DRUG | Idursulfase | IV infusion |
| DRUG | JR-141 or Idursulfase | The subjects who have achieved the pre-specified criteria\* are able to change the drug. \*If a subject in Idursulfase group shows decline in their neurocognitive outcome, idursulfase can be switched to JR-141. If a subject in JR-141 group shows decline in their peripheral outcome, JR-141 will be switched to idursulfase. |
Timeline
- Start date
- 2022-02-14
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
- First posted
- 2020-10-05
- Last updated
- 2026-03-02
Locations
24 sites across 12 countries: United States, Argentina, Brazil, Colombia, France, Germany, Israel, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04573023. Inclusion in this directory is not an endorsement.