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NCT05271409 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

A Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 3
Development phase
152
Enrollment target
20
Study locations

NCT05271409: Recruiting Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), sponsored by Hoffmann-La Roche.

NCT05271409 is a Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05271409, a Phase 3 study of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 3
Development phase
152 participants
Enrollment target
20
Study locations

Study Summary

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.

Interventions

  • OTHER Placebo
  • DRUG Satralizumab

Study Locations (20)

Ohio

  • University of Cincinnati - Cincinnati
  • Cleveland Clinic Foundation - Cleveland
  • OhioHealth Research Institute - Columbus

Florida

  • University of Florida College of Medicine Gainesville - Gainesville
  • Nemours Children's Clinic - of the Nemours Foundation - Jacksonville

Illinois

  • Northwestern University - Chicago
  • Consultants in Neurology Ltd - Northbrook

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Mayo Clinic- Scottsdale - Scottsdale

California

  • University of California Irvine - Manchester Pavilion - Irvine

Colorado

  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) - Aurora

District of Columbia

  • Medstar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2022-08-30
Est. Completion 2028-12-31
Phase Phase 3
Hoffmann-La Roche

909 total trials

What NCT05271409 shows while recruiting

NCT05271409 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05271409 names 20 study sites across 16 states, led by Ohio, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT05271409 about?

NCT05271409 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease". The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB...

What is the current status of trial NCT05271409?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2022-08-30. Estimated completion is 2028-12-31.

What conditions does trial NCT05271409 study?

This clinical trial studies the following conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD).

What interventions are being tested in trial NCT05271409?

The interventions under investigation include: Placebo (OTHER), Satralizumab (DRUG).

Who is sponsoring clinical trial NCT05271409?

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

Where is trial NCT05271409 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05271409's enrollment target sits among peer trials

152 1514th of 2000 higher than 484 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05271409, the US trial registry maintained by the National Library of Medicine. NCT05271409 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.