A Trial Evaluating Different Dosing Durations of TEPEZZA® Treatment in Patients with Thyroid Eye Disease (TED)

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Horizon Therapeutics USA, Inc.
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Updated on 23 September 2023
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Summary

The overall objective is to investigate the safety, tolerability and need for re-treatment of 3 different TEPEZZA® treatment durations (4, 8, or 16 infusions) in patients with TED.

Description

Participants will be screened for eligibility within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio in a double-masked fashion (stratified by CAS(clinical activity score) [≥3 (active) or <3 (inactive)] and disease severity [severe disease, defined as both proptosis above normal for race and gender with binocular diplopia at Baseline vs. non-severe disease]) to receive one of the following cohorts:

Cohort 1: 4 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 3                               infusions) followed by 4 infusions of:
                         a) Placebo if a participants is a  treatment responder at Week 12 
                         b)  Teprotumumab 20 mg/kg if a participant is a treatment non-responder at Week 12
Cohort 2: 8 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7                                infusions)
Cohort 3: 16 infusions of teprotumumab (10 mg/kg for the first infusion and 20 mg/kg for the remaining 15                            infusions)
Three weeks following the final infusion of the Initial Treatment Period, there will be a comprehensive End-of-Initial Treatment Visit at Week 24 (Cohorts 1 and 2)/Week 48 (Cohort 3). At this visit, all participants will be assessed for treatment response.

Proptosis responders in all cohorts and non-responders in Cohorts 1 and 2 who choose not to receive a second treatment course, will enter a 52 week Initial Follow-up Period.

Proptosis non-responders in Cohorts 1 and 2 who choose to receive a second treatment course (8 infusions) of teprotumumab will receive an infusion q3W.

Proptosis non-responders in Cohort 3 are not eligible for a second treatment course following initial treatment.
Participants in any of the 3 cohorts who are proptosis responders following the Initial Treatment Period and who flare during the Initial Follow up Period will be eligible to receive re treatment.

Details
Condition Thyroid Eye Disease
Treatment Placebo, Teprotumumab
Clinical Study IdentifierNCT05002998
SponsorHorizon Therapeutics USA, Inc.
Last Modified on23 September 2023

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