Trial · NCT04737330

A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)

NCT04737330, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2025-01-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED). Trials, record NCT04737330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04737330

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Trial

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

Title: A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)
NCT number: NCT04737330
Status: Terminated
Phases: Phase 3
Enrollment: 28 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Thyroid Eye Disease, Graves Orbitopathy
Interventions: Secukinumab, Placebo
First posted: 2021-02-03
Last updated: 2026-04-15
Other registries' IDs: eudract:2020-001611-24
Results first posted: 2025-01-09

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	Plan A - Percentage of Participants Achieving Overall Response	Baseline, Week 16	The percentage of participants achieving overall response was defined as follows: \>= 2 points reduction in clinical activity score (CAS) AND \>= 2 mm reduction in proptosis from Baseline in the study eye, provided there was no corresponding deterioration in CAS or proptosis (\>= 2 point or 2 mm increase, respectively) in the fellow eye after 16 weeks of treatment. Due to premature study discontinuation, purely descriptive analyses were performed for the primary endpoint.
Primary	Plan B - Percentage of Participants Achieving Response in Reduction of Proptosis	Baseline, Week 16	The percentage of participants achieving response in reduction of proptosis at Week 16 was defined as follows: reduction of \>= 2 mm from Baseline in the study eye without deterioration (\>= 2 mm increase) of proptosis in the fellow eye. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the primary endpoint.
Secondary	Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Baseline, Week 16	The percentage of participants achieving response in reduction of clinical activity score (CAS) at Week 16 was defined as follows: reduction of \>= 2 points from Baseline in the study eye without deterioration (\>= 2 points increase) of CAS in the fellow eye. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.
Secondary	Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis	Baseline, Week 16	The percentage of participants achieving response in reduction of proptosis at Week 16 was defined as follows: reduction of \>= 2 mm from Baseline in the study eye without deterioration (\>= 2 mm increase) of proptosis in the fellow eye. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.
Secondary	Plan A - Percentage of Participants Achieving Response in Diplopia	Baseline, Week 16	The percentage of participants achieving response in diplopia at Week 16 was defined as follows: Baseline diplopia \> 0 and a reduction of \>= 1 grade with no corresponding deterioration (\>= 1 grade worsening) in the fellow eye at Week 16. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.
Secondary	Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Thyroid Eye Disease (TED) activity was assessed using the CAS at the frequency indicated in the study schedule based on the following signs and symptoms in accordance with the European Group on Graves' Orbitopathy (EUGOGO) guideline: * Symptoms * Spontaneous retrobulbar pain * Pain on attempted upward or downward gaze * Signs * Redness of eyelids * Redness of conjunctiva * Swelling of caruncle or plica * Swelling of eyelids * Swelling of conjunctiva (chemosis) For each item present, 1 point is given. The sum of these points is the CAS score, i.e., minimum score of 0 and maximum score of 7. * Inactive TED: CAS \< 3. * Active TED: CAS \>= 3.
Secondary	Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Proptosis measurements were performed at the frequency indicated in the study schedule. The same Hertel instrument, and the same outer intercanthal distance, were to be used for each measurement. The mean of measurements (change from baseline in millimeters (mm) of proptosis, calculated as: (Post-Baseline value - Baseline value) / Baseline value \* 100)) for each group were presented. Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.
Secondary	Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Thyroid Eye Disease (TED) activity was assessed using the CAS at the frequency indicated in the study schedule based on the following signs and symptoms in accordance with the European Group on Graves' Orbitopathy (EUGOGO) guideline. Improvement in EUGOGO disease severity was categorized: Mild, Moderate to severe and Sight threatening.
Secondary	Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.
Secondary	Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	The Graves' ophthalmopathy quality of life questionnaire (GO-QOL) contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). Due to premature study discontinuation, purely descriptive analyses were performed for the secondary endpoint.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Plan A - Percentage of Participants Achieving Overall Response	Baseline, Week 16	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Plan B - Percentage of Participants Achieving Response in Reduction of Proptosis	Baseline, Week 16	Full Analysis Set (FAS). Due to premature study discontinuation, only Plan A was conducted (no data collected for Plan B, as Plan B was not initiated).
SECONDARY	Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Baseline, Week 16	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis	Baseline, Week 16	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plan A - Percentage of Participants Achieving Response in Diplopia	Baseline, Week 16	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.	Unit on a scale	MEAN
SECONDARY	Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.	millimeters (mm)	MEAN
SECONDARY	Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.	Unit on a scale	MEAN
SECONDARY	Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16	Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.	Unit on a scale	MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group116

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

Outcome	Group	Category	Value	Units
Plan A - Percentage of Participants Achieving Overall Response	Secukinumab 300 mg	Yes	0	Participants
Plan A - Percentage of Participants Achieving Overall Response	Placebo	Yes	0	Participants
Plan A - Percentage of Participants Achieving Overall Response	Secukinumab 300 mg	No	12	Participants
Plan A - Percentage of Participants Achieving Overall Response	Placebo	No	11	Participants
Plan A - Percentage of Participants Achieving Overall Response	Secukinumab 300 mg	Missing	2	Participants
Plan A - Percentage of Participants Achieving Overall Response	Placebo	Missing	3	Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Secukinumab 300 mg	Yes	0	Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Placebo	Yes	3	Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Secukinumab 300 mg	No	12	Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS)	Placebo	No	8	Participants

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Treatment Period (Baseline to Week 16)	STARTED	Secukinumab 300 mg	14
Treatment Period (Baseline to Week 16)	STARTED	Placebo	14
Treatment Period (Baseline to Week 16)	COMPLETED	Secukinumab 300 mg	12
Treatment Period (Baseline to Week 16)	COMPLETED	Placebo	12
Treatment Period (Baseline to Week 16)	NOT COMPLETED	Secukinumab 300 mg	2
Treatment Period (Baseline to Week 16)	NOT COMPLETED	Placebo	2
Follow-up Period (Week 16 to Week 108)	STARTED	Secukinumab 300 mg	12
Follow-up Period (Week 16 to Week 108)	STARTED	Placebo	12
Follow-up Period (Week 16 to Week 108)	COMPLETED	Secukinumab 300 mg	8
Follow-up Period (Week 16 to Week 108)	COMPLETED	Placebo	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events174

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	Lymphadenopathy	Blood and lymphatic system disorders	Secukinumab 300 mg (Double-blind)	1	14
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo (Double-blind)	0	14
other	Lymphadenopathy	Blood and lymphatic system disorders	Any Secukinumab 300 mg (Entire Study)	1	26
other	Neutropenia	Blood and lymphatic system disorders	Secukinumab 300 mg (Double-blind)	1	14
other	Neutropenia	Blood and lymphatic system disorders	Placebo (Double-blind)	0	14
other	Neutropenia	Blood and lymphatic system disorders	Any Secukinumab 300 mg (Entire Study)	1	26
other	Vertigo	Ear and labyrinth disorders	Secukinumab 300 mg (Double-blind)	1	14
other	Vertigo	Ear and labyrinth disorders	Placebo (Double-blind)	0	14
other	Vertigo	Ear and labyrinth disorders	Any Secukinumab 300 mg (Entire Study)	1	26
other	Thyroid dermatopathy	Endocrine disorders	Secukinumab 300 mg (Double-blind)	0	14

1 to 10 of 174Source ClinicalTrials.gov

See all 174 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Secukinumab 300 mg (Double-blind)	0	14
Total, all-cause mortality	Placebo (Double-blind)	0	14
Total, all-cause mortality	Any Secukinumab 300 mg (Entire Study)	0	26
Total, other adverse events	Secukinumab 300 mg (Double-blind)	12	14
Total, other adverse events	Placebo (Double-blind)	12	14
Total, other adverse events	Any Secukinumab 300 mg (Entire Study)	23	26
Total, serious adverse events	Secukinumab 300 mg (Double-blind)	1	14
Total, serious adverse events	Placebo (Double-blind)	1	14
Total, serious adverse events	Any Secukinumab 300 mg (Entire Study)	1	26

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 comparisons0

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

None in this release.

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.

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Read this trial from software.

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

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