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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

NCT06248619 · View on ClinicalTrials.gov ↗

Study Summary

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL Teprotumumab

Study Locations (20)

Arizona

  • Catalina Eye Care - NVISION - PPDS — Tucson

Illinois

  • Advanced Quality Medical Research — Orland Park

Michigan

  • W Kellogg Eye Center — Ann Arbor

Nevada

  • Las Vegas Endocrinology — Henderson

New Jersey

  • The Center for Eye and Facial Plastic Surgery — Somerset

Oregon

  • Casey Eye Institute -515 SW Campus Dr — Portland

Pennsylvania

  • Scheie Eye Institute — Philadelphia

Tennessee

  • University of Tennessee Health Science Center - 848 Adams Ave — Memphis

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2024-07-05
Est. Completion 2026-09-02
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06248619

The ClinicalTrials.gov registry entry for NCT06248619 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06248619 reports 20 study locations spanning 20 distinct geographic areas — top geographies include Arizona, Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06248619 about?

NCT06248619 is a clinical study titled "A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease". The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

What is the current status of trial NCT06248619?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2024-07-05. Estimated completion is 2026-09-02.

What conditions does trial NCT06248619 study?

This clinical trial studies the following conditions: Thyroid Eye Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06248619?

The interventions under investigation include: Placebo (OTHER), Teprotumumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06248619?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06248619 being conducted?

This trial has 20 study locations across Arizona, Illinois, Michigan, Nevada, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial