Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
Thyroid Eye Disease
Investigational drug(s) / intervention(s)
Teprotumumab →Placebo
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
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 | 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 |
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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 Italy