A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
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ClinicalTrials.gov Identifier: NCT06248619 |
Recruitment Status :
Recruiting
First Posted : February 8, 2024
Last Update Posted : May 16, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | January 31, 2024 | ||||||||||||||||||
First Posted Date ICMJE | February 8, 2024 | ||||||||||||||||||
Last Update Posted Date | May 16, 2024 | ||||||||||||||||||
Estimated Study Start Date ICMJE | May 9, 2024 | ||||||||||||||||||
Estimated Primary Completion Date | September 15, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease | ||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||
Brief 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. | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Thyroid Eye Disease | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
80 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | March 1, 2026 | ||||||||||||||||||
Estimated Primary Completion Date | September 15, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT06248619 | ||||||||||||||||||
Other Study ID Numbers ICMJE | HZNP-TEP-305 | ||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Amgen | ||||||||||||||||||
Original Responsible Party | Horizon Pharma USA, Inc. | ||||||||||||||||||
Current Study Sponsor ICMJE | Amgen | ||||||||||||||||||
Original Study Sponsor ICMJE | Horizon Pharma USA, Inc. | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Amgen | ||||||||||||||||||
Verification Date | May 2024 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |