New study explores shorter teprotumumab courses for thyroid eye disease

NCT ID NCT05002998

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study looked at how safe and tolerable different lengths of treatment with teprotumumab are for adults with thyroid eye disease (TED). About 313 participants received the drug for varying durations to see if shorter treatment works as well and reduces side effects. The goal is to find the best dosing schedule and understand if some people need re-treatment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

313 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent. 2. Male or female between the ages of 18 and 80 years, inclusive, at Screening. 3. Initial diagnosis of TED within 7 years prior to Screening. 4. Proptosis ≥3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis \>3 mm above normal for race and gender. 5. Participants must be euthyroid with the 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 duration of the trial. 6. Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial. 7. Diabetic participants must have HbA1c ≤8.0% at Screening. 8. Participants with a history of IBD (ulcerative colitis or Crohn's disease) must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial. Concomitant stable therapies for IBD without modifications in the 3 months prior to Screening are allowed. 9. Women of childbearing potential (including those with an onset of menopause \<2 years prior to Screening, non-therapy-induced amenorrhea for \<12 months prior to Screening or not surgically sterile \[absence of ovaries and/or uterus\]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout the participant's participation in the Follow-up Period); participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of teprotumumab. Highly effective contraceptive methods (with a failure rate \<1% per year), when used consistently and correctly, include implants, injectables, combination oral contraceptives, some intrauterine devices, tubal ligation, sexual abstinence or vasectomized partner. 10. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. Exclusion Criteria: 1. Decreased best-corrected visual acuity due to optic neuropathy, as 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. 3. Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline. 4. Prior orbital irradiation, orbital decompression or strabismus surgery. 5. Planned eyelid surgery during the course of the trial. 6. Alanine aminotransferase or aspartate aminotransferase \>3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73m2 at Screening. 7. Use of any steroid (intravenous \[IV\], 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, as well as steroids used to treat infusion reactions. 8. Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab. 9. Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial. 10. Treatment with any mAb within 3 months prior to Screening. 11. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results. 12. Use of an investigational agent for any condition within 60 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial. 13. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 14. Pregnant or lactating women. 15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant. 16. Known hypersensitivity to any of the components of teprotumumab or prior hypersensitivity reactions to mAbs. 17. Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections. 18. Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial. 19. After 150 participants with a CAS \<3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS \<3 at Baseline.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid eye disease

Contacts and locations

Locations

ARNAS Garibaldi - PO Garibaldi-Centro

Catania, Sicily, 95124, Italy
ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi

Varese, Lombardy, 21100, Italy
Azienda Ospedaliera Universitaria Federico II

Naples, Campania, 80131, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, 56126, Italy
Bascom Palmer Eye Institute

Miami, Florida, 33136-1119, United States
Casey Eye Institute - OHSU

Portland, Oregon, 97239-3130, United States
Centre Hospitalier National D'ophtalmologie Des Quinze Vingts

Paris, 75571, France
Hopital Jean Minjoz

Besançon, Doubs, 25030, France
Hospices Civils de Lyon - Hôpital Louis Pradel

Bron, Rhône, 69677, France
Hospital La Arruzafa

Córdoba, Córdoba, 14012, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen Macarena

Seville, 41009, Spain
Hôpital Claude Huriez-Lille-Rue Michel Polonovski

Lille, 59000, France
Imperial College Healthcare NHS Trust - PPDS

London, London, City of, W21 1NY, United Kingdom
Mayo Clinic - PPDS

Rochester, Minnesota, 55905-0001, United States
Moorfields Eye Hospital - PPDS

London, London, City of, EC1V 2PD, United Kingdom
Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Southampton University Hospitals NHS Trust

Southampton, SO16 9YD, United Kingdom
Stanford University

Palo Alto, California, 94303-3216, United States
The Private Practice of Raymond Douglas, MD - Beverly Hills

Beverly Hills, California, 90210-5192, United States
USC Roski Eye Institute - Los Angeles

Los Angeles, California, 90033, United States
University Hospital of Cardiff

Cardiff, South Glamorgan, CF11 0SN, United Kingdom
University Medicine Göttingen Germany

Göttingen, Lower Saxony, 37075, Germany
University of Colorado - Eye Center - PPDS

Aurora, Colorado, 80045-2517, United States
Universitätsklinikum Essen

Essen, 45122, Germany
Universitätsklinikum Münster

Münster, 48149, Germany
Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

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