A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
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)
Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye). — Week 24
Trial sites (38)
Facility
City
Region
Status
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
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.
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