Trial · NCT04583735

A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease

NCT04583735, Phase 4, Completed, Amgen; results first posted 2024-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease. Trials, record NCT04583735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04583735

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
NCT number: NCT04583735
Status: Completed
Phases: Phase 4
Enrollment: 62 participants, actual
Lead sponsor: Amgen
Conditions: Thyroid Eye Disease, Chronic (Inactive) Thyroid Eye Disease
Interventions: TEPEZZA, Placebo
First posted: 2020-10-12
Last updated: 2024-07-01
Results first posted: 2024-04-26

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Proptosis of Study Eye at Week 24	Baseline, week 24	Proptosis assessments were performed using a Hertel exophthalmometer. It measures the anterior projection of the eye from the lateral orbital rim to the cornea (proptosis).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Proptosis of Study Eye at Week 24	Baseline, week 24	ITT Population with available data at specified time point	Millimieter (mm)	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Proptosis of Study Eye at Week 24	Teprotumumab		-2.41	Standard Error 0.228	Millimieter (mm)
Change From Baseline in Proptosis of Study Eye at Week 24	Placebo		-0.92	Standard Error 0.323	Millimieter (mm)

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-masked Treatment Period	STARTED	Teprotumumab	42
Double-masked Treatment Period	STARTED	Placebo	20
Double-masked Treatment Period	Intent-to-treat Populaton	Teprotumumab	42
Double-masked Treatment Period	Intent-to-treat Populaton	Placebo	20
Double-masked Treatment Period	Safety Analysis Population	Teprotumumab	41
Double-masked Treatment Period	Safety Analysis Population	Placebo	20
Double-masked Treatment Period	COMPLETED	Teprotumumab	39
Double-masked Treatment Period	COMPLETED	Placebo	19
Double-masked Treatment Period	NOT COMPLETED	Teprotumumab	3
Double-masked Treatment Period	NOT COMPLETED	Placebo	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Polycythaemia	Blood and lymphatic system disorders	Teprotumumab	0	41	0
other	Polycythaemia	Blood and lymphatic system disorders	Placebo	1	20	1
other	Ear discomfort	Ear and labyrinth disorders	Teprotumumab	2	41	2
other	Ear discomfort	Ear and labyrinth disorders	Placebo	2	20	3
other	Hypoacusis	Ear and labyrinth disorders	Teprotumumab	4	41	4
other	Hypoacusis	Ear and labyrinth disorders	Placebo	0	20	0
other	Tinnitus	Ear and labyrinth disorders	Teprotumumab	2	41	2
other	Tinnitus	Ear and labyrinth disorders	Placebo	2	20	3
other	Blepharospasm	Eye disorders	Teprotumumab	1	41	1
other	Blepharospasm	Eye disorders	Placebo	1	20	1

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Teprotumumab	0	41
Total, all-cause mortality	Placebo	0	20
Total, other adverse events	Teprotumumab	33	41
Total, other adverse events	Placebo	16	20
Total, serious adverse events	Teprotumumab	1	41
Total, serious adverse events	Placebo	1	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42837042	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Teprotumumab vs Placebo: deaths from any cause	Trial comparisons
Teprotumumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04583735

GET https://conductscience.org/api/trials/v1/NCT04583735/events?page=2

API reference For AI assistants