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New shot could ease bulging eyes from thyroid disease

NCT ID NCT06248619

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This phase 3 trial tests an injectable drug called teprotumumab for people with moderate-to-severe active thyroid eye disease, a condition that causes eye bulging and discomfort. About 89 adults will receive either the drug or a placebo injection to see if it reduces eye bulging by at least 2 mm. The study is already active but not recruiting, and results may lead to a new treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
teprotumumab (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could offer a more convenient way to treat thyroid eye disease and reduce eye bulging and inflammation.
What could go wrong
This is still a clinical trial, so it may not work better than placebo. Side effects are possible, and results may not apply to everyone with the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

89 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

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. Participant must provide written informed consent. 2. Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening. 3. Participant must have a clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at Screening and Baseline. 4. Participant must have moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or inconstant or constant diplopia. (Note: Participants with no diplopia at Baseline will be limited to approximately 25% of the total number enrolled.) 5. Participant has 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. 6. Participant had onset of active TED symptoms (as determined by participant records) within 15 months prior to Baseline. 7. Participants must be euthyroid with the baseline disease under control or have mild hypoor hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine \[FT3\] 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. 8. Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial. 9. Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (ie, prior to each dose and throughout participation in the trial). 10. Participant is willing and able to comply with the protocol requirements for the duration of the trial. Exclusion Criteria: 1. Participant has decreased best-corrected visual acuity due to optic neuropathy, defined by a decrease in vision of 2 lines on the Snellen chart (or equivalent), new visual field defect or color defect secondary to optic nerve involvement within the last 6 months. 2. Participant has corneal decompensation unresponsive to medical management. 3. Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline. 4. Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline. 5. Participant had prior orbital irradiation, orbital decompression or strabismus surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease). 6. Participant is planning to have eyelid surgery during the trial. 7. Participant received periocular botulinum toxin injection within 12 months prior to Screening. 8. Participant has any systemic use of a steroid (IV or oral) or steroid eye drops for the treatment of TED or other conditions within 3 weeks prior to Screening. Exceptions include local administration (excluding periocular), eg, topical, intra-articular, and inhaled steroids, as well as steroids used to treat infusion reactions.

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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

  • AP-HM-Hôpital de La Conception

    Marseille, Bouches-du-Rhône, 13010, France

  • Advanced Quality Medical Research

    Orland Park, Illinois, 60462, United States

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

    Pisa, 56124, Italy

  • Baylor College of Medicine-1977 Butler Blvd

    Houston, Texas, 77030-4101, United States

  • CHU de Quebec-Universite Laval CUO Recherche Clinique Hopital du St-Sacrement

    Québec, G1S 4L8, Canada

  • Casey Eye Institute -515 SW Campus Dr

    Portland, Oregon, 97239-3130, United States

  • Catalina Eye Care - NVISION - PPDS

    Tucson, Arizona, 85712, United States

  • Centre For Eye Research Australia Ltd

    East Melbourne, Victoria, 3002, Australia

  • Centro Medico Grupo Laser Vision

    Rosario, Santa Fe Province, S2000, Argentina

  • Changhua Christian Hospital

    Changhua County, 50006, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, Taiwan

  • Gokeikai Osaka Kaisei Hospital

    Osaka-Shi Yodogawa-Ku, Ôsaka, 532-0003, Japan

  • Hayashi Eye Hospital

    Fukuoka, Hukuoka, 812-0011, Japan

  • Hospital Universitari i Politecnic La Fe de Valencia-Avda de Fernando Abril Martorell 106

    Valencia, 46026, Spain

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530, Japan

  • Kozawa Eye hospital and Diabetes Center

    Mito, Ibaraki, 310-0845, Japan

  • Las Vegas Endocrinology

    Henderson, Nevada, 89074, United States

  • McGill University Health Centre Research Institute

    Montreal, Quebec, H4A 3J1, Canada

  • Moorfields Eye Hospital - PPDS

    London, Middlesex, EC1V 2PD, United Kingdom

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Organización Médica de Investigación

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1015ABO, Argentina

  • Queensland Eye Institute

    Wooloongabba, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    Adelaie, South Australia, 5000, Australia

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104-2640, United States

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • The Center for Eye and Facial Plastic Surgery

    Somerset, New Jersey, 08773, United States

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, 889-1601, Japan

  • University of Tennessee Health Science Center - 848 Adams Ave

    Memphis, Tennessee, 38103-3452, United States

  • University of Washington Eye Institute

    Seattle, Washington, 98104-2433, United States

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Vancouver Coastal Health Research Institute (VCHRI) - 2550 Willow St

    Vancouver, British Columbia, V5Z 3N9, Canada

  • W Kellogg Eye Center

    Ann Arbor, Michigan, 48105-1912, United States

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506-1200, United States

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