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NCT04075266 · ClinicalTrials.gov registry record · Phase 2

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

A Phase 2 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 2
Development phase
23
Enrollment target
12
Study locations

NCT04075266 is a Phase 2 study of Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 23 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The trial reports 12 study locations across 8 states.

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The verdict

NCT04075266, a Phase 2 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
23 participants
Enrollment target
12
Study locations

Study Summary

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Conditions Studied

Multiple Sclerosis

Interventions

  • DRUG Ocrelizumab

Study Locations (12)

Other

  • Uniwersyteckie Centrum Kliniczne - Gda?sk
  • Uniwersytecki Szpital Kliniczny w Poznaniu - Późna
  • Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego - Warsaw
  • Instytut Pomnik Centrum Zdrowia Dziecka - Warsaw

Lazio

  • Ospedale Pediatrico Bambino Gesù - Rome
  • Azienda Ospedaliera Sant'Andrea - Rome

Colorado

  • University of Colorado Denver Childrens Hospital Rocky Mountain MS Center - Aurora

District of Columbia

  • Childrens National Health Center - Washington D.C.

Massachusetts

  • Boston Childrens Hospital - Boston

Missouri

  • Washington Universtiy school of Medicine - St Louis

Ohio

  • Cleveland Clinic - Cleveland

Sicily

  • AOU Policlinico V. Emanuele - P.O G. Rodolico - Catania

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2020-01-09
Est. Completion 2029-12-01
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04075266

The ClinicalTrials.gov registry entry for NCT04075266 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ocrelizumab is the first listed.

NCT04075266 reports 12 study locations spanning 8 distinct geographic areas - top geographies include Other, Lazio, Colorado.

Frequently Asked Questions

What is clinical trial NCT04075266 about?

NCT04075266 is a clinical study titled "A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis". This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of o...

What is the current status of trial NCT04075266?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-01-09. Estimated completion is 2029-12-01.

What conditions does trial NCT04075266 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT04075266?

The interventions under investigation include: Ocrelizumab (DRUG).

Who is sponsoring clinical trial NCT04075266?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04075266 being conducted?

This trial has 12 study locations across Colorado, District of Columbia, Massachusetts, Missouri, Ohio. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.