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Enzyme Replacement Therapy
JR-141 for Hunter Syndrome
Phase 3
Recruiting
Research Sponsored by JCR Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with confirmed diagnosis of MPS II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 13, 26, 53, 78, 105
Awards & highlights
Study Summary
This trial is testing a new drug for MPS II, a disease that causes problems with the nervous system and organs. The trial will compare the new drug to the current standard of care to see if it is safe and effective.
Who is the study for?
This trial is for patients with Hunter Syndrome (MPS II). Eligible participants include those diagnosed with MPS II, either treatment-naïve or on stable enzyme therapy. They must agree to use effective contraception and sign consent forms. There are specific age-related cognitive criteria for two separate cohorts: Cohort A includes children aged 36-71 months with certain developmental scores, while Cohort B includes individuals aged 6 years or older with an IQ of 70 or higher.Check my eligibility
What is being tested?
The STARLIGHT Phase III trial is testing the safety and effectiveness of a drug called JR-141 compared to Idursulfase in treating MPS II. Participants will be randomly assigned to receive either JR-141 alone, JR-141 combined with Idursulfase, or only Idursulfase in a blinded manner where assessors do not know which treatment each participant receives.See study design
What are the potential side effects?
While the specific side effects of JR-141 are not listed here, similar treatments often cause reactions at injection sites, allergic responses, headaches, fever and chills. Side effects can vary from person to person based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MPS II.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in levels of cerebrospinal fluid heparan sulfate from baseline (Cohort A)
Change in the raw scores of cognitive testing measured from baseline (BSID-III) (Cohort A)
Secondary outcome measures
Change in the age equivalent scores of adaptive behavior measured from baseline (VABS-II) (Cohort A)
Change in the growth scores of cognitive testing measured from baseline (BSID-III) (Cohort A)
Relative change in distance walked using the 6-minute walk test from baseline to Week 53 (Cohort B)
+2 moreOther outcome measures
Absolute change in the Forced Expiratory Volume from baseline (Cohort B)
Absolute change in the Forced Vital Capacity from baseline (Cohort B)
Absolute change in the percent predicted Forced Vital Capacity from baseline (Cohort B)
+50 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: administered as the standard of care: idursulfase (ELAPRASE®)Experimental Treatment1 Intervention
standard of care-controlled study
Group II: Rescue armExperimental Treatment1 Intervention
Group III: JR-141 2.0 mg/kg/weekExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JR-141
2018
Completed Phase 3
~60
Idursulfase
2012
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
JCR Pharmaceuticals Co., Ltd.Lead Sponsor
11 Previous Clinical Trials
231 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a successful stem cell transplant.I have a genetic mutation linked to developmental delays or seizures.For children 36-42 months old, their measured development score must be 85 or less. For children 43-71 months old, either their development quotient should be between 20 to 85, or their composite standard score on a specific test should be 85 or less. Children 30-35 months old must be assessed as having a severe condition by an Expert Board.I am 6 or older with an IQ of 70 or more and fit the specific test criteria for Cohort B.I have had brain surgery or a shunt placed in the last 30 days, or my shunt isn't working well.I have received gene therapy treatment before.I have a documented loss of sulfatase activity, not including IDS.I cannot have a lumbar puncture procedure.I may have an infection or a higher risk of bleeding due to my health condition or treatments.I have not started treatment or have been on stable enzyme therapy for over 12 weeks.I have been diagnosed with MPS II.
Research Study Groups:
This trial has the following groups:- Group 1: Rescue arm
- Group 2: JR-141 2.0 mg/kg/week
- Group 3: administered as the standard of care: idursulfase (ELAPRASE®)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have a record of prior research on JR-141?
"JR-141 was first studied a decade ago at the Legacy Emanuel Hospital. In the 2010s, there have been 10 completed clinical trials in total. Right now, 8 different medical studies are still recruiting patients; many of these trials are based in Chicago, Illinois."
Answered by AI
Is this a new or existing type of clinical research?
"There are 8 ongoing clinical trials for JR-141 across the globe, with the first study having taken place in 2010. 25 patients completed Phase 1 & 2 of the drug approval process that year, and 10 more trials have been carried out since then."
Answered by AI
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