TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Thyroid Eye Disease

In brief

This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.

Key facts

Study ID

NCT05002998

Run by

Amgen

People needed

313

Starts

2021-09-16

Expected to finish

2025-12-19

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent.
• Male or female between the ages of 18 and 80 years, inclusive, at Screening.
• Initial diagnosis of TED within 7 years prior to Screening.
• 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.
• 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.
• Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
• Diabetic participants must have HbA1c ≤8.0% at Screening.
• 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.
• 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.
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

You may not qualify if…

• 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.
• Corneal decompensation unresponsive to medical management.
• Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline.
• Prior orbital irradiation, orbital decompression or strabismus surgery.
• Planned eyelid surgery during the course of the trial.
• Alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal or estimated glomerular filtration rate ≤30 mL/min/1.73m2 at Screening.
• 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.
• 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.
• Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial.
• Treatment with any mAb within 3 months prior to Screening.
• Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results.
• 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.
• Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
• Pregnant or lactating women.
• 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.
• Known hypersensitivity to any of the components of teprotumumab or prior hypersensitivity reactions to mAbs.
• Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections.
• Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.
• After 150 participants with a CAS <3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS <3 at Baseline.

Where it is running

• The Private Practice of Raymond Douglas, MD - Beverly Hills — Beverly Hills, California, United States
• USC Roski Eye Institute - Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Colorado - Eye Center - PPDS — Aurora, Colorado, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Mayo Clinic - PPDS — Rochester, Minnesota, United States
• Casey Eye Institute - OHSU — Portland, Oregon, United States
• Hopital Jean Minjoz — Besançon, Doubs, France
• Hospices Civils de Lyon - Hôpital Louis Pradel — Bron, Rhône, France
• Hôpital Claude Huriez-Lille-Rue Michel Polonovski — Lille, France
• Centre Hospitalier National D'ophtalmologie Des Quinze Vingts — Paris, France
• Universitätsklinikum Tübingen — Tübingen, Baden-Wurttemberg, Germany
• University Medicine Göttingen Germany — Göttingen, Lower Saxony, Germany
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Rhineland-Palatinate, Germany
• Universitätsklinikum Essen — Essen, Germany
• Universitätsklinikum Münster — Münster, Germany
• Azienda Ospedaliera Universitaria Federico II — Naples, Campania, Italy
• ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi — Varese, Lombardy, Italy
• ARNAS Garibaldi - PO Garibaldi-Centro — Catania, Sicily, Italy
• Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara — Pisa, Tuscany, Italy
• Hospital La Arruzafa — Córdoba, Córdoba, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Moorfields Eye Hospital - PPDS — London, London, City of, United Kingdom
• Imperial College Healthcare NHS Trust - PPDS — London, London, City of, United Kingdom

Full record on ClinicalTrials.gov

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