A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
Purpose
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.
Condition
- Thyroid Eye Disease
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Teprotumumab |
Teprotumumab administered SC |
|
|
Placebo Comparator Placebo |
Placebo for teprotumumab administered SC |
|
Recruiting Locations
Kansas City, Kansas 66160-8500
More Details
- Status
- Recruiting
- Sponsor
- Amgen
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.