Adults 18 to 80, any sex, with Thyroid Eye Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a ≥ 2 mm Reduction From Baseline in the Study Eye Without Deterioration of Proptosis in the Fellow Eye at Week 24Primary· Baseline, Week 24
Proptosis responders were defined as participants with a ≥ 2 mm reduction from study baseline in proptosis in the study eye, without deterioration (≥ 2 mm increase) of proptosis in the fellow eye at Week 24. Participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic.
Group
Value
95% CI
Teprotumumab (OPTIC Placebo)
89.2
Teprotumumab (OPTIC Teprotumumab)
53.8
Percentage of Participants With a European Group on Graves' Ophthalmopathy (EUGOGO) Amended Clinical Activity Score (CAS) Total Score of 0 or 1 in the Study Eye at Week 24Secondary· Week 24
CAS responders were defined as participants with a reduction to a CAS of 0 or 1 (no or minimal inflammatory symptoms) as a categorical response variable at Week 24.
The 7-item CAS assigns 1 point for each of the following items present in the study eye: spontaneous orbital pain; gaze evoked orbital pain; eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/Graves' ophthalmopathy (TED/GO); eyelid erythema; conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); chemosis; inflammation of car
Group
Value
95% CI
Teprotumumab (OPTIC Placebo)
65.6
Teprotumumab (OPTIC Teprotumumab)
36.4
Change in Proptosis From Baseline to Week 24Secondary· Study Baseline, Week 24
Mean change from study baseline to Week 24 in proptosis measurement (mm) in the study eye at Week 24.
Group
Value
95% CI
Teprotumumab (OPTIC Placebo)
-3.47
± 1.732
Teprotumumab (OPTIC Teprotumumab)
-1.77
± 1.126
Percentage of Participants Who Were Diplopia Responders at Week 24Secondary· Week 24
Diplopia responders were defined as participants with 1 grade or greater reduction in diplopia score in the study eye without worsening by at least 1 grade in the fellow eye at Week 24.
The subjective diplopia score (0=no diplopia; 1=intermittent, i.e. diplopia in primary position of gaze, when tired or when first awakening; 2=inconstant, i.e. diplopia at extremes of gaze; 3=constant, i.e. continuous diplopia in primary or reading position) was recorded for each eye. A participant was considered to have diplopia if a score \> 0 is observed in the study eye at study baseline.
Group
Value
95% CI
Teprotumumab (OPTIC Placebo)
60.9
Teprotumumab (OPTIC Teprotumumab)
75.0
Mean Change From Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall ScoreSecondary· Study Baseline, Week 24
The GO-QoL is a 16-item self-administered questionnaire divided into 2 subsets and used to assess the perceived effects of TED by the participants on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The sum of the scores from each set of 8 questions was calculated and transformed to a scale from 0 (worst) to 100 (best) - one for visual function (VF), one for appearance (A) and one for the overall combined (VF + A) score. Scores were transformed as follows: Transformed score = \[(sum of each score - number of completed items) / (2 \* number
Group
Value
95% CI
Teprotumumab (OPTIC Placebo)
13.39
± 17.890
Teprotumumab (OPTIC Teprotumumab)
14.73
± 11.777
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality and Serious Adverse Events (AEs): from informed consent through 30 days after study discontinuation. Mean days on study was 332.9 and 218.8 for Teprotumumab (OPTIC Placebo) and Teprotumumab (OPTIC Teprotumumab) arms, respectively..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were either proptosis non-responders at Week 24 of HZNP-TEP-301 or were proptosis responders at Week 24 but met the criteria for re-treatment due to relapse during the Follow-Up Period of HZNP-TEP-301.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07142642 — A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in H
· Phase 1
· completed
NCT07085117 — Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients
· completed
NCT06248619 — A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participa
· Phase 3
· active not recruiting
NCT06674941 — A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Ja
· Phase 1
· completed
NCT06389578 — A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease
· Phase 1
· completed
Other recruiting trials for Thyroid Eye Disease
Currently open trials in the same condition.
NCT07423013 — Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.
· NA
· recruiting
NCT07113262 — A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
· Phase 3
· recruiting
NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease
· Phase 1
· active not recruiting
NCT06625411 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
· Phase 3
· active not recruiting
NCT06625398 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 28 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03461211.