A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

June 2, 2026 updated by: JCR Pharmaceuticals Co., Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Universitario Austral
  • Brazil
      • Porto Alegre, Brazil
        • Hospital de Clinicas de Porto Alegre
      • São Paulo, Brazil
        • Instituto de Genética e Erros Inatos do Metabolismo
  • Colombia
      • Bogotá, Colombia
        • Fundación Cardio Infantil - Instituto de Cardiología
  • France
      • Lyon, France
        • Hopital Femme Mere Enfant
      • Montpellier, France
        • Chu De Montpellier Hopital Gui De Chauliac
      • Paris, France
        • Hôpital Armand Trousseau
  • Germany
      • Giessen, Germany
        • Universitätsklinikum Gießen
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf
      • Höchheim, Germany
        • SphinCS GmbH
      • Mainz, Germany
        • Universitatsmedizin Mainz
  • Israel
      • Afula, Israel
        • Ha'Emek Medical Center
  • Italy
      • Rome, Italy
        • Osp. Pediatrico Bambino Gesù, IRCCS
  • Poland
      • Krakow, Poland
        • Uniwersytecki Szpital Dziecięcy
  • Spain
      • Barcelona, Spain
        • Hospital Sant Joan de Déu
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Gazi University Medicine Faculty Hospital
      • Izmir, Turkey (Türkiye)
        • Ege University Children Hospital
  • United Kingdom
      • London, United Kingdom
        • Great Ormond Street Hospital for Children NHS Trust - Metabolic Medicine
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 27599-7487
        • Phoenix Children's Hospital
    • California
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital Oakland
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7487
        • University of North Carolina at Chapel Hill Medical School Wing E
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A patient who voluntarily signs an Institutional Review Board or Independent Ethics Committee-approved written informed consent form. If the patient is aged under 18 years (aged under 16 years in the UK) at the time of enrollment or willingness to participate in the study cannot be confirmed due to MPS II-related intellectual disability, the patient's legally acceptable representative (e.g., his/her parents or guardians) may sign the informed consent on behalf of the patient. Written informed assent should be obtained from the patient, wherever possible.
  • Patients with confirmed diagnosis of MPS II
  • Naïve patients or patients who are receiving stable enzyme replacement therapy with idursulfase for more than 12 weeks before starting administration of JR-141 or idursulfase for this study.
  • Patients or patients whose partners are of child-bearing potential agree to use a medically accepted, highly effective method of contraception being use of condoms from the time of informed consent.

<Cohort A>

  • Patients aged 36-42 months old at the time of ICF signing: patients must have a standard score measured by the BSID-III of 85 or less at screening.
  • Patients aged 43-71 months old at the time of ICF signing: patients must EITHER have (1) A DQ measured by BSID-III of 20 to 85 at screening OR (2) A composite standard score on NVI measured by KABC-II of 85 or less at screening (only who can perform KABC-II)
  • Patients aged 30-35 months old at the time of randomization and who are judged as having the severe phenotype by the Expert Board.

<Cohort B>

  • Patients 6 years of age or older at the time of ICF signing and whose IQ are 70 and higher.
  • Enrollment of subjects in Cohort B is contingent on the availability in that country of a validated country-specific version of the test (either WISC-V, WAIS-IV, or T.O.V.A.).
  • Attenuated patients with 1 SD deficiency in the omission errors or variability domains of the T.O.V.A..
  • Patients or patients whose female partners are of child-bearing potential i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile, agree to use a medically accepted, highly effective method of contraception, from the time of informed consent. The method of contraception must be used during the study until 90 days for male subjects, and 30 days for female subjects after the final study intervention administration.
  • For subjects with hearing impairment requiring hearing aid(s), every effort has been made to encourage compliance with the use of functioning hearing aid(s) before baseline neurocognitive assessments, and parent/legally acceptable representative or subject agrees to encourage wearing them during the study and on neurocognitive testing days.

Exclusion Criteria:

  • A patient with a history of HSCT with successful engraftment.
  • A patient who has received gene therapy treatment at any point.
  • A patient who is judged by the principal investigator or sub-investigator as being unable to undergo lumbar puncture, including those who have difficulties in taking position for lumbar puncture due to joint contracture or those who are likely to experience breathing difficulties during the lumbar puncture process.
  • A patient who is enrolled in another clinical study that involves clinical investigations or use of any investigational product (drug or device) within 4 months before obtaining informed consent.
  • Unable to comply with the protocol as determined by the principal investigator or subinvestigator.
  • Judged by the principal investigator or subinvestigator to be ineligible to participate in the study due to a history of serious drug allergy or sensitivity including anesthesia or hypersensitivity to any component of JR-141.
  • A patient who has a known or suspected local or general infection or is at risk of abnormal bleeding due to medical conditions or therapies.
  • A patient who has documented mutation of other genes, including loci adjacent to the IDS gene that are known to be associated with developmental delay, seizures, or other significant CNS disorders.
  • A patient who has documented loss of activity of sulfatases other than IDS.
  • A patient who has had a ventriculoperitoneal shunt placed or any other brain surgery, or has a clinically significant ventriculoperitoneal shunt malfunction within 30 days of screening.
  • A patient who is full time employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members.
  • A patient who otherwise is judged by the principle investigator or sub-investigator to be ineligible to participate in the study.
  • The subject has a positive pregnancy test or is breastfeeding at screening or randomization.

[Only in France]

  • Persons deprived of their liberty by a judicial or administrative decision, according to article L.1121-6 the Public Health Code (Code de la santé publique), adults who are the subject of a measure of legal protection or unable to express their consent according to article L. 1121-8 of the Code de la santé publique)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JR-141 2.0 mg/kg/week
Drug: JR-141
IV infusion, 2.0 mg/kg/week
Other: administered as the standard of care: idursulfase (ELAPRASE®)
standard of care-controlled study
Drug: Idursulfase
IV infusion
Other: Rescue arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in levels of cerebrospinal fluid heparan sulfate from baseline (Cohort A)
Time Frame: Baseline to Week 53
Baseline to Week 53
Change in the raw scores of cognitive testing measured from baseline (BSID-III) (Cohort A)
Time Frame: Baseline to Week 105
Baseline to Week 105

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
For regions other than US: Change in the age equivalent scores of cognitive testing measured from baseline (BSID-III or KABC-II) (Cohort A)
Time Frame: Baseline to Week 105
Baseline to Week 105
For regions other than US: Change in the age equivalent scores of adaptive behavior measured from baseline (VABS-II) (Cohort A)
Time Frame: Baseline to Week 105
Baseline to Week 105
For the US: Change in the raw scores of adaptive behavior measured from baseline (VABS-II) (Cohort A)
Time Frame: Baseline to Week 105
Baseline to Week 105
For all regions: Relative change in liver volume relative to body weight from baseline (Cohort A and Cohort B)
Time Frame: Baseline to Week 53
Baseline to Week 53
For all regions: Relative change in spleen volume relative to body weight from baseline (Cohort A and Cohort B)
Time Frame: Baseline to Week 53
Baseline to Week 53

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in levels of cerebrospinal fluid heparan sulfate from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 105
Baseline to Week 26, 105
Change in levels of cerebrospinal fluid dermatan sulfate from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in levels of cerebrospinal fluid heparan sulfate from baseine. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in levels of cerebrospinal fluid dermatan sulfate from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in adaptive behavioral testing measured from baseline
Time Frame: Baseline to Week 26, 53, 78, 105
Vineland Adaptive Behavior Scales (Cohort A)
Baseline to Week 26, 53, 78, 105
Change in adaptive behavioral testing measured from baseline
Time Frame: Baseline to Week 26, 53
Vineland Adaptive Behavior Scales (Cohort B)
Baseline to Week 26, 53
Change in cognitive testing measured from baseline
Time Frame: Baseline to Week 26, 53, 78, 105
BSID-III and KABC-II (Cohort A)
Baseline to Week 26, 53, 78, 105
Change in the standard scores on omission error and variability domain measured by T.O.V.A. or composite scores on Processing speed or Working Memory measured by WISC/WAIS from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in adaptive behavior measured by VABS-II, and intelligence scale measured by WISC/WAIS from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the Quality of Life by HS FOCUS from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the Quality of Life by PedsQL from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 78, 105
Baseline to Week 26, 53, 78, 105
Change in the Quality of Life by PedsQL from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the Quality of Life by PedsQL-FIM from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 78, 105
Baseline to Week 26, 53, 78, 105
Change in the Quality of Life by PedsQL-FIM from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the Quality of Life by CSHQ from baseline.(Cohort A)
Time Frame: Baseline to Week 26, 53, 78, 105
Baseline to Week 26, 53, 78, 105
Change in the Quality of Life by CSHQ from baseline.(Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the global impression of severity and change by CGI from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 78, 105
Baseline to Week 26, 53, 78, 105
Change in the global impression of severity and change by CGI from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the global impression of severity and change by PGI from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 78, 105
Baseline to Week 26, 53, 78, 105
Change in the global impression of severity and change by PGI from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the Toileting Abilities Survey from baseline. (Cohort A)
Time Frame: Baseline to Week 13, 26, 53, 78, 105
Baseline to Week 13, 26, 53, 78, 105
Change in the Toileting Abilities Survey from baseline. (Cohort B)
Time Frame: Baseline to Week 13, 26, 53
Baseline to Week 13, 26, 53
Change in Auditory Brainstem Response. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in Auditory Brainstem Response. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in cerebrospinal fluid opening pressure. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in cerebrospinal fluid opening pressure. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Relative change in liver volume relative to body weight from baseline (Cohort A)
Time Frame: Baseline to Week 26, 105
Baseline to Week 26, 105
Relative change in liver volume relative to body weight from baseline (Cohort B)
Time Frame: Baseline to Week 26
Baseline to Week 26
Relative change in spleen volume relative to body weight from baseline (Cohort A)
Time Frame: Baseline to Week 26, 105
Baseline to Week 26, 105
Relative change in spleen volume relative to body weight from baseline (Cohort B)
Time Frame: Baseline to Week 26
Baseline to Week 26
Relative change in distance walked using the 6-minute walk test from baseline (Cohort B)
Time Frame: Baseline to Week 26
Baseline to Week 26
Change in Joint Range of Motion by goniometer from baseline (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in Joint Range of Motion by goniometer from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Absolute change in the Forced Vital Capacity from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Absolute change in the Forced Expiratory Volume from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Absolute change in the percent predicted Forced Vital Capacity from baseline (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in levels of serum heparan sulfate from baseline (Cohort A)
Time Frame: Baseline to Week 13, 26, 53, 78, 105
Baseline to Week 13, 26, 53, 78, 105
Change in levels of serum heparan sulfate from baseline (Cohort B)
Time Frame: Baseline to Week 13, 26, 53
Baseline to Week 13, 26, 53
Change in levels of serum dermatan sulfate from baseline (Cohort A)
Time Frame: Baseline to Week 13, 26, 53, 78, 105
Baseline to Week 13, 26, 53, 78, 105
Change in levels of serum dermatan sulfate from baseline (Cohort B)
Time Frame: Baseline to Week 13, 26, 53
Baseline to Week 13, 26, 53
Change in levels of the urine heparan sulfate from baseline. (Cohort A)
Time Frame: Baseline to Week 13, 26, 53, 78, 105
Baseline to Week 13, 26, 53, 78, 105
Change in levels of the urine heparan sulfate from baseline. (Cohort B)
Time Frame: Baseline to Week 13, 26, 53
Baseline to Week 13, 26, 53
Change in levels of the urine dermatan sulfate from baseline. (Cohort A)
Time Frame: Baseline to Week 13, 26, 53, 78, 105
Baseline to Week 13, 26, 53, 78, 105
Change in levels of the urine dermatan sulfate from baseline. (Cohort B)
Time Frame: Baseline to Week 13, 26, 53
Baseline to Week 13, 26, 53
Change in the left ventricular mass index (LVMI) from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in LVMI from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the interventricular septum thickness (IVST) from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in IVST from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Change in the posterior wall thickness (PWT) from baseline. (Cohort A)
Time Frame: Baseline to Week 26, 53, 105
Baseline to Week 26, 53, 105
Change in PWT from baseline. (Cohort B)
Time Frame: Baseline to Week 26, 53
Baseline to Week 26, 53
Growth velocity (Cohort A)
Time Frame: Week 53, 105
Week 53, 105
Growth velocity (Cohort B)
Time Frame: Week 53
Week 53
Ongoing assessment of adverse events.
Time Frame: Through study period
adverse drug reactions (Cohort A and Cohort B)
Through study period
Antibodies
Time Frame: Baseline, Week 105
Plasma: Anti-IDS antibody (Cohort A)
Baseline, Week 105
Antibodies
Time Frame: Baseline, Week 53
Plasma: Anti-IDS antibody (Cohort B)
Baseline, Week 53
Antibodies
Time Frame: Baseline, Week 5, 13, 26, 53, 78,105
Plasma: Anti-JR-141 antibody (Cohort A)
Baseline, Week 5, 13, 26, 53, 78,105
Antibodies
Time Frame: Baseline, Week 5, 13, 26, 53
Plasma: Anti-JR-141 antibody (Cohort B)
Baseline, Week 5, 13, 26, 53
Antibodies
Time Frame: Baseline, Week 26, 53, 105
Cerebrospinal fluid: Anti-JR-141 antibody (Cohort A)
Baseline, Week 26, 53, 105
Antibodies
Time Frame: Baseline, Week 26, 53
Cerebrospinal fluid: Anti-JR-141 antibody (Cohort B)
Baseline, Week 26, 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JCR Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JR-141-GS31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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