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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

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 participan
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
1/05/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Queensland Eye Institute - Wooloongabba
Recruitment hospital [3] 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
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
Kansas
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
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
United States of America
State/province [8] 0 0
West Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autónoma De BuenosAires
Country [10] 0 0
Japan
State/province [10] 0 0
Hukuoka
Country [11] 0 0
Japan
State/province [11] 0 0
Ibaraki
Country [12] 0 0
Japan
State/province [12] 0 0
Isikawa
Country [13] 0 0
Japan
State/province [13] 0 0
Miyazaki
Country [14] 0 0
Japan
State/province [14] 0 0
Niigata
Country [15] 0 0
Japan
State/province [15] 0 0
Ôsaka

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
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://amgen.com/datasharing


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