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NCT05987423 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

A Phase 3 study of Thyroid Eye Disease and TED, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
131
Enrollment target
20
Study locations

NCT05987423 is a Phase 3 study of Thyroid Eye Disease and TED that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 131 participants, above the 98-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT05987423, a Phase 3 study of Thyroid Eye Disease and TED, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
131 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Satralizumab

Study Locations (20)

Other

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada - Buenos Aires
  • Centro Oftalmologico Dr. Charles S.A. - Capital Federal
  • Oftalmos - Capital Federal
  • Buenos Aires Mácula - Ciudad Autonoma Buenos Aires
  • Centrovision Mendoza - Mendoza
  • Grupo Laser Vision - Rosario

California

  • Thrive Health Research LLC - Beverly Hills
  • UCSD Shiley Eye Center - La Jolla

Michigan

  • University of Michigan, Kellogg Eye Center - Ann Arbor
  • Great Lakes Eye Care - Saint Joseph

Kansas

  • Grene Vision Group, LLC - Wichita

Maryland

  • Johns Hopkins University - Baltimore

New York

  • 'Northwell Health Physician Partners Ophthalmology - Great Neck

Oregon

  • EyeHealth Northwest - Portland

Texas

  • Austin Retina Associates - Austin

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2023-10-26
Est. Completion 2026-07-01
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT05987423

The ClinicalTrials.gov registry entry for NCT05987423 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 98-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (34% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05987423 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT05987423 about?

NCT05987423 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease". The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

What is the current status of trial NCT05987423?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2023-10-26. Estimated completion is 2026-07-01.

What conditions does trial NCT05987423 study?

This clinical trial studies the following conditions: Thyroid Eye Disease, TED.

What interventions are being tested in trial NCT05987423?

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

Who is sponsoring clinical trial NCT05987423?

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

Where is trial NCT05987423 being conducted?

This trial has 20 study locations across California, Kansas, Maryland, Michigan, New York. 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.