Thyroid Eye DiseasePhase 3NCT06248619
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
A Phase 3 study testing Teprotumumab in people with Thyroid Eye Disease, run by Amgen at 38 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Teprotumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 38 sitesin 11 countries
- Study dates
- 5 Jul 2024to 13 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must provide written informed consent.
- Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.
- 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.
- 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.)
- 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.
- Participant had onset of active TED symptoms (as determined by participant records) within 15 months prior to Baseline.
Show all 10Show fewer
- 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.
- Participant does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.
- 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).
- Participant is willing and able to comply with the protocol requirements for the duration of the trial.
Who cannot join
- 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.
- Participant has corneal decompensation unresponsive to medical management.
- Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.
- Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.
- Participant had prior orbital irradiation, orbital decompression or strabismus surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease).
- Participant is planning to have eyelid surgery during the trial.
- Participant received periocular botulinum toxin injection within 12 months prior to Screening.
- 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.
Trial locations and contacts
38 sites in 11 countries.
38 sites in 11 countries
United States11 sites
W Kellogg Eye Center
Ann Arbor, Michigan, 48105-1912
Las Vegas Endocrinology
Henderson, Nevada, 89074
Baylor College of Medicine-1977 Butler Blvd
Houston, Texas, 77030-4101
University of Tennessee Health Science Center - 848 Adams Ave
Memphis, Tennessee, 38103-3452
West Virginia University Eye Institute
Morgantown, West Virginia, 26506-1200
Advanced Quality Medical Research
Orland Park, Illinois, 60462
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104-2640
Casey Eye Institute -515 SW Campus Dr
Portland, Oregon, 97239-3130
University of Washington Eye Institute
Seattle, Washington, 98104-2433
The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey, 08773
Catalina Eye Care - NVISION - PPDS
Tucson, Arizona, 85712
Japan5 sites
Hayashi Eye Hospital
Fukuoka, Hukuoka, 812-0011
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Kozawa Eye hospital and Diabetes Center
Mito, Ibaraki, 310-0845
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1601
Gokeikai Osaka Kaisei Hospital
Osaka-Shi Yodogawa-Ku, Ôsaka, 532-0003
Australia4 sites
Royal Adelaide Hospital
Adelaie, South Australia, 5000
Centre For Eye Research Australia Ltd
East Melbourne, Victoria, 3002
Sydney Eye Hospital
Sydney, New South Wales, 2000
Queensland Eye Institute
Wooloongabba, Queensland, 4102
Argentina3 sites
Organización Médica de Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires, C1015ABO
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT
Centro Medico Grupo Laser Vision
Rosario, Santa Fe Province, S2000
Canada3 sites
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1
CHU de Quebec-Universite Laval CUO Recherche Clinique Hopital du St-Sacrement
Québec, G1S 4L8
Vancouver Coastal Health Research Institute (VCHRI) - 2550 Willow St
Vancouver, British Columbia, V5Z 3N9
Italy3 sites
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
Pisa, 56124
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56124
Spain3 sites
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitari i Politecnic La Fe de Valencia-Avda de Fernando Abril Martorell 106
Valencia, 46026
Taiwan3 sites
Changhua Christian Hospital
Changhua County, 50006
Chung Shan Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei, 100
United Kingdom1 site
Moorfields Eye Hospital - PPDS
London, Middlesex, EC1V 2PD
About this study
Official title: A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in 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.
Read the detailed description
The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at Week 24.
Acquired from Horizon in 2024.
- Conditions
- Thyroid Eye Disease
- Being tested
- Teprotumumab, Placebo
- Keywords
- Teprotumumab, Active Thyroid Eye Disease, Tepezza, Teprotumumab-trbw
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeprotumumabBiological
SC injection
PlaceboOther
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Teprotumumab | Experimental | Teprotumumab administered SC Receives: Biological: Teprotumumab |
| Placebo | Placebo comparator | Placebo for teprotumumab administered SC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 24
Secondary outcomes (7)
Mean change from Baseline in proptosis measurement in the study eye
Measured: Week 24
Overall responder rate (percentage of participants with ≥ 2-point reduction in CAS AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye)
Measured: Week 24
Percentage of participants with a CAS value of 0 or 1
Measured: Week 24
Change from Baseline in diplopia as ordinal response categories
Measured: Week 24
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade
Measured: Week 24
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0
Measured: Week 24
Mean change from Baseline in the GO-QoL questionnaire overall score
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Jul 2024
- Primary completion23 Dec 2025
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248619
- Sponsor's protocol ID
- HZNP-TEP-305
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06248619
- Acronym / sponsor ID
- HZNP-TEP-305
- Conditions
- Thyroid Eye Disease
- Keywords
- Teprotumumab, Active Thyroid Eye Disease, Tepezza, Teprotumumab-trbw
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at Week 24.
Acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teprotumumab | Experimental | Biological: TeprotumumabTeprotumumab administered SC |
| Placebo | Placebo comparator | Other: PlaceboPlacebo for teprotumumab administered SC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must provide written informed consent.
- Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.
- 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.
- 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.)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Participant has corneal decompensation unresponsive to medical management.
- Participant has a decrease in CAS of ≥ 2 points between Screening and Baseline.
- Participant has a decrease in proptosis of ≥ 2 mm between Screening and Baseline.
- Participant had prior orbital irradiation, orbital decompression or strabismus surgery (excluding childhood strabismus surgeries unrelated to TED/Graves' disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeprotumumabSC injection | Biological | Teprotumumab |
| PlaceboSC injection | Other | Placebo |
Primary outcome
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).
Time frame: Week 24
7 secondary outcomes
Mean change from Baseline in proptosis measurement in the study eye
Time frame: Week 24
Overall responder rate (percentage of participants with ≥ 2-point reduction in CAS AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye)
Time frame: Week 24
Percentage of participants with a CAS value of 0 or 1
Time frame: Week 24
Change from Baseline in diplopia as ordinal response categories
Time frame: Week 24
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade
Time frame: Week 24
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0
Time frame: Week 24
Mean change from Baseline in the GO-QoL questionnaire overall score
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
38 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teprotumumab in people with Thyroid Eye Disease, run by Amgen at 38 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Australia, Argentina, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.