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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    300
  • sponsor
    Horizon Therapeutics USA, Inc.
Updated on 23 July 2022

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 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Initial diagnosis of TED within 7 years prior to Screening
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
Participants must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels <50% above or below the normal limits) at Screening. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the duration of the trial
Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial
Diabetic participants must have HbA1c ≤8.0% at Screening

Exclusion Criteria

Decreased best-corrected visual acuity due to optic neuropathy, as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement within the last 6 months
Corneal decompensation unresponsive to medical management
Decrease in proptosis of ≥2 mm in the study eye between Screening and Baseline
Use of any steroid (intravenous [IV], oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids, as well as steroids used to treat infusion reactions
Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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