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NCT03153319 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI

A Phase 1 study of Mucopolysaccharidosis II and Mucopolysaccharidosis VI, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

Active
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT03153319 is a Phase 1 study of Mucopolysaccharidosis II and Mucopolysaccharidosis VI that is active but no longer recruiting, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 14 participants, below the 72-participant average among 7 other Mucopolysaccharidosis II trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03153319, a Phase 1 study of Mucopolysaccharidosis II and Mucopolysaccharidosis VI, is active but no longer recruiting, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

Randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by open-label phase, to evaluate the effects of adalimumab compared to placebo on the change from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis (MPS) I, II or VI.

Interventions

  • DRUG Saline Solution for Injection
  • DRUG Adalimumab Injection [Humira]

Study Locations (1)

California

  • The Lundquist Institute at Harbor-UCLA Medical Center - Torrance

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2017-06-05
Est. Completion 2027-02
Phase Phase 1

What the Registry Record Tells You About NCT03153319

The ClinicalTrials.gov registry entry for NCT03153319 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 72-participant average among 7 other Mucopolysaccharidosis II trials with a reported enrollment target (81% lower). The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Mucopolysaccharidosis II appearing as the primary indexed condition, and to 2 interventions - of which Saline Solution for Injection is the first listed.

NCT03153319 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03153319 about?

NCT03153319 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI". Randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by open-label phase, to evaluate the effects of adalimumab compared to placebo on the change from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis (MPS) I, II or VI.

What is the current status of trial NCT03153319?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2017-06-05. Estimated completion is 2027-02.

What conditions does trial NCT03153319 study?

This clinical trial studies the following conditions: Mucopolysaccharidosis II, Mucopolysaccharidosis VI, Mucopolysaccharidosis I.

What interventions are being tested in trial NCT03153319?

The interventions under investigation include: Saline Solution for Injection (DRUG), Adalimumab Injection [Humira] (DRUG).

Who is sponsoring clinical trial NCT03153319?

This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03153319 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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