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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: Active Phase 3 study of Thyroid Eye Disease and TED, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
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
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2023-10-26 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 3 |
What the registry record for NCT05987423 still lists
NCT05987423 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 98-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (34% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Thyroid Eye Disease
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 NCT05987423's enrollment target sits among peer trials
131 3rd of 15 higher than 13 of 15 other Thyroid Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thyroid Eye Disease 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
-
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
-
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
-
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
ACTIVE NOT RECRUITING · Phase 3
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