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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06248619




Registration number
NCT06248619
Ethics application status
Date submitted
31/01/2024
Date registered
8/02/2024
Date last updated
26/06/2025

Titles & IDs
Public title
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
Scientific 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
Secondary ID [1] 0 0
HZNP-TEP-305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Eye Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Teprotumumab
Other interventions - Placebo

Experimental: Teprotumumab - Teprotumumab administered SC

Placebo comparator: Placebo - Placebo for teprotumumab administered SC


Treatment: Other: Teprotumumab
SC injection

Other interventions: Placebo
SC injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Mean change from Baseline in proptosis measurement in the study eye
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of participants with a CAS value of 0 or 1
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change from Baseline in diplopia as ordinal response categories
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of = 1 grade
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Mean change from Baseline in the GO-QoL questionnaire overall score
Timepoint [7] 0 0
Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/09/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Queensland Eye Institute - Wooloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaie
Recruitment hospital [4] 0 0
Centre For Eye Research Australia Ltd - East Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaie
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
West Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autónoma De BuenosAires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Bouches-du-Rhône
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Italy
State/province [20] 0 0
Campania
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Japan
State/province [22] 0 0
Hukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Ibaraki
Country [24] 0 0
Japan
State/province [24] 0 0
Isikawa
Country [25] 0 0
Japan
State/province [25] 0 0
Miyazaki
Country [26] 0 0
Japan
State/province [26] 0 0
Niigata
Country [27] 0 0
Japan
State/province [27] 0 0
Ôsaka
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Spain
State/province [30] 0 0
Valencia
Country [31] 0 0
Taiwan
State/province [31] 0 0
Changhua County
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taichung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06248619