Study to evaluate TEPEZZA® in patients with Chronic (Inactive) Thyroid Eye Disease (TED)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    57
  • sponsor
    Horizon Therapeutics USA, Inc.
Updated on 20 May 2022

Summary

The goal is to determine the efficacy, safety and tolerability of TEPEZZA® for treating chronic (inactive) TED. About 57 participants will start with a 24-week treatment period. Patients that do not meet the desired response after the 24-week treatment period may receive up to 8 additional infusions of TEPEZZA®.  After completion of the treatment period, there will be a follow up phone call for final safety evaluation.

Description

This is a randomized, double-masked, placebo-controlled, parallel-group, multicenter trial. Participants will be screened for the trial within 4 weeks prior to Baseline (Day 1). Approximately 57 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 2:1 ratio to receive 8 infusions of TEPEZZA or placebo once every 3 weeks. All participants will enter a 24-week double-masked Treatment Period, during which trial drug will be infused on Day 1 (Baseline) and Weeks 3, 6, 9, 12, 15, 18 and 21 (with a final visit at Week 24 of the 24-week Treatment Period). At the end of the double-masked Treatment Period (Week 24), all patients will be assessed for treatment response. Non-responders may choose to receive 8 infusions of TEPEZZA in an open-label fashion q3W at Weeks 24, 27, 30, 33, 36, 39, 42 and 45. 

Details
Condition Thyroid Eye Disease, Chronic (Inactive) Thyroid Eye Disease
Treatment Placebo, TEPEZZA
Clinical Study IdentifierNCT04583735
SponsorHorizon Therapeutics USA, Inc.
Last Modified on20 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Initial diagnosis of TED ≥2 years but <10 years prior to Screening. Clinical diagnosis of stable, chronic (inactive) TED, as determined by participant medical records indicating a Clinical Activity Score (CAS) ≤1 in both eyes for at least 1 year prior to Screening or all of the following: no progression in proptosis for at least 1 year prior to Screening; if participant has history of diplopia due to TED, no progression in diplopia for at least 1 year prior to Screening; no new inflammatory TED symptoms for at least 1 year prior to Screening
Proptosis ≥3-mm increase from participant's 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 participant's 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 full duration of the trial
Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial
Patients with a history of inflammatory bowel disease, ulcerative colitis or Crohn's disease must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to screening and no planned surgery during the trial. Concomitant stable therapies for inflammatory bowel disease without modifications in the 3 months prior to Screening are allowed

Exclusion Criteria

Decreased best-corrected visual acuity due to optic neuropathy, 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 in the study eye
Pregnant or lactating women
Prior orbital irradiation, orbital decompression in the study eye; Prior strabismus surgery
Use of any steroid (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 and steroids used to treat infusion reactions; Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of trial drug or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of trial drug. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of trial drug; Any previous treatment with TEPEZZA; Treatment with any mAb within 3 months prior to Screening
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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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