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Clinical Trials in the UK / NCT06248619
Active, not recruiting Phase 3

A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

NCT06248619 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-07-05
Last updated
2026-07-07

Condition(s) studied

Thyroid Eye Disease

Investigational drug(s) / intervention(s)

TeprotumumabPlacebo

Teprotumumab: SC injection

Placebo: SC injection

Study summary

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Catalina Eye Care - NVISION - PPDS Tucson Arizona
Advanced Quality Medical Research Orland Park Illinois
W Kellogg Eye Center Ann Arbor Michigan
Las Vegas Endocrinology Henderson Nevada
The Center for Eye and Facial Plastic Surgery Somerset New Jersey
Casey Eye Institute -515 SW Campus Dr Portland Oregon
Scheie Eye Institute Philadelphia Pennsylvania
University of Tennessee Health Science Center - 848 Adams Ave Memphis Tennessee
Baylor College of Medicine-1977 Butler Blvd Houston Texas
University of Washington Eye Institute Seattle Washington
West Virginia University Eye Institute Morgantown West Virginia
Hospital Universitario Austral Pilar Buenos Aires
Organización Médica de Investigación Buenos Aires Ciudad Autónoma de BuenosAires
Centro Medico Grupo Laser Vision Rosario Santa Fe Province
Sydney Eye Hospital Sydney New South Wales
Queensland Eye Institute Wooloongabba Queensland
Royal Adelaide Hospital Adelaie South Australia
Centre For Eye Research Australia Ltd East Melbourne Victoria
Vancouver Coastal Health Research Institute (VCHRI) - 2550 Willow St Vancouver British Columbia
McGill University Health Centre Research Institute Montreal Quebec
CHU de Quebec-Universite Laval CUO Recherche Clinique Hopital du St-Sacrement Québec Canada
AP-HM-Hôpital de La Conception Marseille Bouches-du-Rhône
Universitätsklinikum Essen Essen North Rhine-Westphalia
Azienda Ospedaliera Universitaria Federico II Naples Campania
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello Pisa Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara Pisa Italy
Hayashi Eye Hospital Fukuoka Hukuoka
Kozawa Eye hospital and Diabetes Center Mito Ibaraki
Ishikawa Prefectural Central Hospital Kanazawa Ishikawa-ken
University of Miyazaki Hospital Miyazaki Miyazaki
Gokeikai Osaka Kaisei Hospital Osaka-Shi Yodogawa-Ku Ôsaka
Hospital Universitario Ramon y Cajal Madrid Spain
Hospital Universitario Virgen Macarena Seville Spain
Hospital Universitari i Politecnic La Fe de Valencia-Avda de Fernando Abril Martorell 106 Valencia Spain
Changhua Christian Hospital Changhua County Taiwan
Chung Shan Medical University Hospital Taichung Taiwan
National Taiwan University Hospital Taipei Taiwan
Moorfields Eye Hospital - PPDS London Middlesex

More Amgen trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06248619 on ClinicalTrials.gov ↗ ← All trials in the UK