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NCT06106828 · 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, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT06106828: Active Phase 3 study of Thyroid Eye Disease, sponsored by Hoffmann-La Roche.
NCT06106828 is a Phase 3 study of Thyroid Eye Disease that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 127 participants, above the 98-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06106828, a Phase 3 study of Thyroid Eye Disease, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 127 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 have been reported. Percentages have been rounded off.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Satralizumab
Study Locations (20)
Other
- Peking Union Medical College Hospital - Beijing
- Peking University Third Hospital - Beijing
- Beijing Hospital of Ministry of Health - Beijing
- Beijing Tongren Hospital, Capital Medical University - Beijing
- Xi'an Fourth Hospital - Xi'an
- CHU Nantes - Hotel Dieu - Nantes
- CHNO Hopital des Quinze Vingts - Paris
- Fondation Rothschild - Paris
- Hadassah MC - Jerusalem
- Rabin MC - Petah Tikva
- Sheba medical center - Ramat Gan
California
- Plastics-Orbit-Neuro - San Diego
Connecticut
- Connecticut Eye Consultants, P.C. - Danbury
Illinois
- University of Illinois Eye and Ear Infirmary - Chicago
Pennsylvania
- Scheie Eye Institute - Philadelphia
Tennessee
- Vanderbilt Eye Institute - Nashville
Texas
- Retina Consultants of Texas - San Antonio
Alberta
- University of Alberta - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2026-06-25 |
| Phase | Phase 3 |
What the registry record for NCT06106828 still lists
NCT06106828 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (30% higher).
The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06106828 names 20 study sites across 10 states, led by Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06106828 about?
NCT06106828 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 NCT06106828?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2023-11-15. Estimated completion is 2026-06-25.
What conditions does trial NCT06106828 study?
This clinical trial studies the following conditions: Thyroid Eye Disease.
What interventions are being tested in trial NCT06106828?
The interventions under investigation include: Placebo (DRUG), Satralizumab (DRUG).
Who is sponsoring clinical trial NCT06106828?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06106828 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Pennsylvania, Tennessee. 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 NCT06106828's enrollment target sits among peer trials
127 4th of 15 higher than 12 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 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab 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 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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