Trial · NCT04478994

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

NCT04478994, Phase 1, Terminated, Amgen; results first posted 2024-04-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc). Trials, record NCT04478994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04478994

On this page

Trial

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

Title: A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
NCT number: NCT04478994
Status: Terminated
Phases: Phase 1
Enrollment: 3 participants, actual
Lead sponsor: Amgen
Conditions: Diffuse Cutaneous Systemic Sclerosis
Interventions: TEPEZZA, Placebo
First posted: 2020-07-21
Last updated: 2024-06-28
Results first posted: 2024-04-19

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24	From first dose of trial drug up to Week 24	An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. TEAEs are those that occurred after the first dose of trial drug.

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	Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24	From first dose of trial drug up to Week 24	All randomized participants	Participants	COUNT_OF_PARTICIPANTS

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
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24	TEPEZZA 20 mg/kg		0		Participants
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24	Placebo		2		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	TEPEZZA 20 mg/kg	1
Overall Study	STARTED	Placebo	2
Overall Study	COMPLETED	TEPEZZA 20 mg/kg	0
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	TEPEZZA 20 mg/kg	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events14

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
other	Anaemia	Blood and lymphatic system disorders	TEPEZZA 20 mg/kg	0	1
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	2
other	Abdominal pain	Gastrointestinal disorders	TEPEZZA 20 mg/kg	0	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	2
other	Diarrhoea	Gastrointestinal disorders	TEPEZZA 20 mg/kg	0	1
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	2
other	Fatigue	General disorders	TEPEZZA 20 mg/kg	0	1
other	Fatigue	General disorders	Placebo	1	2
other	Urinary tract infection	Infections and infestations	TEPEZZA 20 mg/kg	0	1
other	Urinary tract infection	Infections and infestations	Placebo	1	2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TEPEZZA 20 mg/kg	0	1
Total, all-cause mortality	Placebo	0	2
Total, other adverse events	TEPEZZA 20 mg/kg	0	1
Total, other adverse events	Placebo	2	2
Total, serious adverse events	TEPEZZA 20 mg/kg	0	1
Total, serious adverse events	Placebo	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
TEPEZZA 20 mg/kg vs Placebo: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24	Trial comparisons
TEPEZZA 20 mg/kg vs Placebo: deaths from any cause	Trial comparisons
TEPEZZA 20 mg/kg 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/NCT04478994

GET https://conductscience.org/api/trials/v1/NCT04478994/registered

API reference For AI assistants