Completed

A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Teprotumumab

Drug
Who is being recruted

Autoimmune Diseases+11

+ Endocrine System Diseases

+ Exophthalmos

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2022
See protocol details

Summary

Principal SponsorAmgen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 14, 2022

Actual date on which the first participant was enrolled.

This study focuses on evaluating two different formulations of the drug teprotumumab in people with thyroid eye disease, a condition that affects the eyes and surrounding tissues. The main goals are to understand how the body processes these formulations, and to check their safety and how well they are tolerated. Thyroid eye disease can cause serious eye problems, and this research may help improve treatment options by determining the most effective and safest way to administer teprotumumab. Participants in this study receive teprotumumab in two different ways: first, as a single dose given under the skin (subcutaneous) and then through multiple doses injected into a vein (intravenous). The study carefully monitors how the drug moves through and affects the body. Researchers will look for any side effects or reactions to ensure that the medication is safe for further testing and use. The study involves a small group of participants, divided into two cohorts, to gather precise information on the drug's performance.

Official TitleA Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease
NCT06389578
Principal SponsorAmgen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesEndocrine System DiseasesExophthalmosEye DiseasesGoiterGraves DiseaseHyperthyroidismImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOrbital DiseasesThyroid DiseasesEye Diseases, HereditaryGenetic Diseases, InbornGraves Ophthalmopathy

Criteria

5 inclusion criteria required to participate
Thyroid eye disease (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis, and/or inconstant or constant diplopia.
Proptosis ≥ 3 mm increase from the participant's baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥ 3 mm above normal for race and gender.
Participant must be euthyroid with baseline disease under control or have mild hypo- or hyperthyroidism at Screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial.
Does not require immediate surgical ophthalmological intervention.
Show More Criteria
8 exclusion criteria prevent from participating
Decreased best-corrected visual acuity due to optic neuropathy within the last 6 months.
Corneal decompensation unresponsive to medical management in the study eye.
Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
Alanine aminotransferase or aspartate aminotransferase > 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2 at Screening.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive a single dose of lyophilized teprotumumab by subcutaneous (SC) administration on Day 1 followed by intravenous (IV) infusions of teprotumumab at the approved dosing regimen.

Group II

Experimental
Participants will receive a single high concentration formulation teprotumumab by SC administration on Day 1 followed by IV infusions of teprotumumab at the approved dosing regimen.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Bascom Palmer Eye Institute - University of Miami

Miami, United StatesOpen Bascom Palmer Eye Institute - University of Miami in Google Maps
Suspended

Barnes Jewish Hospital Washington University

St Louis, United States
Suspended

Neuro-Eye Clinical Trials

Bellaire, United States
Completed3 Study Centers