A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

PHASE3RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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...
  • Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-07-05

    Primary completion: 2025-10-15

    Study completion finish: 2026-05-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06248619

    Intervention or treatment

    BIOLOGICAL: Teprotumumab

    OTHER: Placebo

    Conditions

    • Thyroid Eye Disease

    Find a site

    Closest Location:

    Centre For Eye Research Australia Ltd

    Research sites nearby

    Select from list below to view details:

    • Centre For Eye Research Australia Ltd

      East Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Teprotumumab
    • Teprotumumab administered SC
    BIOLOGICAL: Teprotumumab
    • SC injection
    PLACEBO_COMPARATOR: Placebo
    • Placebo for teprotumumab administered SC
    OTHER: Placebo
    • SC injection

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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).Not SpecifiedWeek 24

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Mean change from Baseline in proptosis measurement in the study eyeNot SpecifiedWeek 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)Not SpecifiedWeek 24
    Percentage of participants with a CAS value of 0 or 1Not SpecifiedWeek 24
    Change from Baseline in diplopia as ordinal response categoriesNot SpecifiedWeek 24
    Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 gradeNot SpecifiedWeek 24
    Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0Not SpecifiedWeek 24
    Mean change from Baseline in the GO-QoL questionnaire overall scoreNot SpecifiedWeek 24

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    References

    Clinical Trials Gov: 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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