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A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

NCT04583735•Amgen

View on ClinicalTrials.gov

Summary

The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled. There will be a treatment period (through Week 24) and a follow up period (where TEPEZZA will not be infused).

Detailed Description

This is a randomized, double-masked, placebo-controlled, parallel-group, multicenter trial. Participants will be screened for the trial within 4 weeks prior to Baseline (Day 1). Approximately 57 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 2:1 ratio to receive 8 infusions of TEPEZZA or placebo once every 3 weeks. All participants will enter a 24-week double-masked Treatment Period, during which trial drug will be infused on Day 1 (Baseline) and Weeks 3, 6, 9, 12, 15, 18 and 21 (with a final visit at Week 24 of the 24-week Treatment Period). At the end of the double-masked Treatment Period (Week 24), all patients will be assessed for treatment response. Non-responders may choose to receive 8 infusions of TEPEZZA in an open-label fashion q3W at Weeks 24, 27, 30, 33, 36, 39, 42 and 45. Study acquired from Horizon in 2024.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent.
•2. Male or female at least 18 years old at Screening.
•3. Initial diagnosis of TED ≥2 years but \<10 years prior to Screening. Clinical diagnosis of stable, chronic (inactive) TED, as determined by participant medical records indicating a Clinical Activity Score (CAS) ≤1 in both eyes for at least 1 year prior to Screening or all of the following:
•1. no progression in proptosis for at least 1 year prior to Screening
•2. if participant has history of diplopia due to TED, no progression in diplopia for at least 1 year prior to Screening
•3. no new inflammatory TED symptoms for at least 1 year prior to Screening
•4. CAS ≤1 at the Screening and Baseline Visits.
•5. Proptosis ≥3-mm increase from participant's Baseline (prior to diagnosis of TED), as estimated by treating physician and/or proptosis ≥3 mm above normal for race and gender.
•6. Participants must be euthyroid with the participant's Baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels \<50% above or below the normal limits) 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.
•7. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
+4 more criteria

Exclusion Criteria

•1. Decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement 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. Prior orbital irradiation, orbital decompression in the study eye.
•5. Prior strabismus surgery.
•6. Alanine aminotransferase or aspartate aminotransferase \>3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73 m2 at Screening.
•7. 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.
•8. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of trial drug or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of trial drug. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of trial drug.
•9. Any previous treatment with TEPEZZA, including previous enrollment in this trial or participation in a prior teprotumumab trial.
•10. Treatment with any mAb within 3 months prior to Screening.
+8 more criteria

Locations (12)

The Private Practice of Raymond Douglas

Beverly Hills, California, United States

Perlman Medical Offices / UCSD

La Jolla, California, United States

MACRO Trials

Los Angeles, California, United States

Univ of Colorado Dept of Ophthalmology

Aurora, Colorado, United States

Bascom Palmer Eye Institute / Univ of Miami

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Las Vegas Endocrinology

Las Vegas, Nevada, United States

Endocrinology Specialists & Thyroid Center

Greenville, South Carolina, United States

Hamilton Eye Institute / U Tennessee

Memphis, Tennessee, United States

Key Dates

Start Date

September 2, 2021

Primary Completion Date

March 17, 2023

Completion Date

October 12, 2023

Last Updated

July 1, 2024

Enrollment

ACTUAL participants

Conditions

Thyroid Eye DiseaseChronic (Inactive) Thyroid Eye Disease

Interventions

TEPEZZA

BIOLOGICAL

Placebo

DRUG

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RECRUITINGNA

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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: July 1, 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 Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) 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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