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A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

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

NCT06389578•Amgen

View on ClinicalTrials.gov

Summary

The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.

Detailed Description

This is a Phase 1b, open-label, multicenter trial to assess the PK, safety, and tolerability of a single SC dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. Approximately 6 participants (in Cohort 1) and approximately 10 participants (in Cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio. Study acquired from Horizon in 2024.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. Does not require immediate surgical ophthalmological intervention.
•5. Participants with diabetes must have HbA1c ≤ 8.0% at Screening.

Exclusion Criteria

•1. Decreased best-corrected visual acuity due to optic neuropathy within the last 6 months.
•2. Corneal decompensation unresponsive to medical management in the study eye.
•3. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
•4. Alanine aminotransferase or aspartate aminotransferase \> 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2 at Screening.
•5. Use of any steroid (IV, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat infusion reactions.
•6. Any treatment with rituximab, tocilizumab, or any other non-steroid immunosuppressive agent within 90 days prior to the first injection of investigational product on Day 1.
•7. Any previous treatment with HZN-001 or TEPEZZA (teprotumumab-trbw), including previous enrollment in this trial or participation in a prior TEPEZZA trial.
•8. Treatment with any mAb within 3 months prior to Screening.

Locations (3)

Bascom Palmer Eye Institute - University of Miami

Miami, Florida, United States

Barnes Jewish Hospital Washington University

St Louis, Missouri, United States

Neuro-Eye Clinical Trials

Bellaire, Texas, United States

Key Dates

Start Date

July 14, 2022

Primary Completion Date

February 28, 2023

Completion Date

September 12, 2023

Last Updated

June 21, 2024

Enrollment

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

Teprotumumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

Inclusion Criteria

Exclusion Criteria

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

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