Trial Outcomes & Findings for A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED) (NCT NCT04737330)

Last Updated: 2025-01-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2025-01-09

Participant Flow

This study was conducted at 5 centers in Germany.

Eligible participants were randomized in a 1:1 ratio to one of the following double-blinded treatment arms: Secukinumab 300 mg (arm 1) and Placebo (arm 2).

Participant milestones

Participant milestones
Measure	Secukinumab 300 mg Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Treatment Period (Baseline to Week 16) STARTED	14	14
Treatment Period (Baseline to Week 16) COMPLETED	12	12
Treatment Period (Baseline to Week 16) NOT COMPLETED	2	2
Follow-up Period (Week 16 to Week 108) STARTED	12	12
Follow-up Period (Week 16 to Week 108) COMPLETED	8	9
Follow-up Period (Week 16 to Week 108) NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 300 mg Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Treatment Period (Baseline to Week 16) Lost to Follow-up	1	0
Treatment Period (Baseline to Week 16) Study terminated by sponsor	1	2
Follow-up Period (Week 16 to Week 108) Not satisfied	1	0
Follow-up Period (Week 16 to Week 108) Study terminated by sponsor	3	1
Follow-up Period (Week 16 to Week 108) No benefit IMP	0	1
Follow-up Period (Week 16 to Week 108) Therapy national guidelines	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Total n=28 Participants Total of all reporting groups
Age, Continuous	53.6 Years STANDARD_DEVIATION 11.85 • n=5 Participants	57.7 Years STANDARD_DEVIATION 10.64 • n=7 Participants	55.6 Years STANDARD_DEVIATION 11.25 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Smoking History Current	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Smoking History Former	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Smoking History Never	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set (FAS)

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Percentage of Participants Achieving Overall Response Yes	0 Participants	0 Participants
Plan A - Percentage of Participants Achieving Overall Response No	12 Participants	11 Participants
Plan A - Percentage of Participants Achieving Overall Response Missing	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: 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).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS) Yes	0 Participants	3 Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS) No	12 Participants	8 Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Clinical Activity Score (CAS) Missing	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis Yes	0 Participants	0 Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis No	12 Participants	11 Participants
Plan A - Percentage of Participants Achieving Response in Reduction of Proptosis Missing	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Percentage of Participants Achieving Response in Diplopia Yes	1 Participants	1 Participants
Plan A - Percentage of Participants Achieving Response in Diplopia No	11 Participants	11 Participants
Plan A - Percentage of Participants Achieving Response in Diplopia Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye Change from BL at Week 2	-0.21 Unit on a scale Standard Deviation 0.58	-0.29 Unit on a scale Standard Deviation 0.47
Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye Change from BL at Week 4	-0.14 Unit on a scale Standard Deviation 1.10	-0.29 Unit on a scale Standard Deviation 0.73
Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye Change from BL at Week 8	0.00 Unit on a scale Standard Deviation 1.00	-0.21 Unit on a scale Standard Deviation 0.58
Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye Change from BL at Week 12	-0.67 Unit on a scale Standard Deviation 1.15	-0.57 Unit on a scale Standard Deviation 0.94
Plan A - Mean Change From Baseline to Week 16 in Clinical Activity Score (CAS) in the Study Eye Change from BL at Week 16	0.00 Unit on a scale Standard Deviation 0.95	-0.73 Unit on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye Change from BL at Week 16	0.83 millimeters (mm) Standard Deviation 1.03	0.64 millimeters (mm) Standard Deviation 1.03
Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye Change from BL at Week 2	0.18 millimeters (mm) Standard Deviation 0.72	-0.07 millimeters (mm) Standard Deviation 0.73
Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye Change from BL at Week 4	0.18 millimeters (mm) Standard Deviation 0.72	0.00 millimeters (mm) Standard Deviation 1.18
Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye Change from BL at Week 8	0.42 millimeters (mm) Standard Deviation 1.00	0.43 millimeters (mm) Standard Deviation 1.28
Plan A - Mean Change From Baseline to Week 16 in Millimeters (mm) of Proptosis in the Study Eye Change from BL at Week 12	0.67 millimeters (mm) Standard Deviation 0.98	0.29 millimeters (mm) Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Baseline · Mild	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Baseline · Moderate to severe	14 Participants	14 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Baseline · Sight threatening	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 2 · Mild	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 2 · Moderate to severe	14 Participants	14 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 2 · Sight threatening	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 4 · Mild	1 Participants	1 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 4 · Moderate to severe	13 Participants	12 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 4 · Sight threatening	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 8 · Mild	0 Participants	1 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 8 · Moderate to severe	13 Participants	13 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 8 · Sight threatening	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 12 · Mild	1 Participants	1 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 12 · Moderate to severe	11 Participants	13 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 12 · Sight threatening	0 Participants	0 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 16 · Mild	1 Participants	1 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 16 · Moderate to severe	11 Participants	10 Participants
Plan A - Percentage of Participants With Improvement in EUGOGO Disease Severity Week 16 · Sight threatening	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

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.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Baseline	64.1 Unit on a scale Standard Deviation 23.04	66.6 Unit on a scale Standard Deviation 24.38
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Week 2	62.9 Unit on a scale Standard Deviation 27.71	66.4 Unit on a scale Standard Deviation 20.51
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Week 4	56.7 Unit on a scale Standard Deviation 28.11	66.7 Unit on a scale Standard Deviation 23.82
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Week 8	51.0 Unit on a scale Standard Deviation 27.93	59.1 Unit on a scale Standard Deviation 24.75
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Week 12	54.7 Unit on a scale Standard Deviation 29.45	60.8 Unit on a scale Standard Deviation 28.71
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 1: Visual Functioning) Over Time Week 16	52.1 Unit on a scale Standard Deviation 29.36	61.9 Unit on a scale Standard Deviation 30.42

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Baseline	65.6 Unit on a scale Standard Deviation 22.43	60.3 Unit on a scale Standard Deviation 20.60
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Week 2	68.3 Unit on a scale Standard Deviation 16.16	62.5 Unit on a scale Standard Deviation 29.42
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Week 4	69.2 Unit on a scale Standard Deviation 21.01	56.7 Unit on a scale Standard Deviation 30.37
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Week 8	65.4 Unit on a scale Standard Deviation 20.51	52.2 Unit on a scale Standard Deviation 30.87
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Week 12	63.5 Unit on a scale Standard Deviation 26.09	53.1 Unit on a scale Standard Deviation 34.47
Plan A - Graves' Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Score (Score 2: Psychosocial Functioning) Over Time Week 16	66.2 Unit on a scale Standard Deviation 26.84	56.8 Unit on a scale Standard Deviation 30.55

SECONDARY outcome

Timeframe: From first dose of study treatment until Week 16

Population: Safety Analysis Set (SAF)

The distribution of adverse events during Plan A study treatment period was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg n=14 Participants Secukinumab 300 mg subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12	Placebo n=14 Participants Placebo subcutaneous (s.c.) injection at Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12
Plan A - Number of Participants With Adverse Events Any adverse event (AE)	9 Participants	6 Participants
Plan A - Number of Participants With Adverse Events Study treatment related AE	3 Participants	1 Participants
Plan A - Number of Participants With Adverse Events AE leading to study treatment discontinuation	0 Participants	0 Participants
Plan A - Number of Participants With Adverse Events Serious adverse event (SAE)	0 Participants	1 Participants
Plan A - Number of Participants With Adverse Events Study treatment related SAE	0 Participants	0 Participants
Plan A - Number of Participants With Adverse Events SAE leading to study treatment discontinuation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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).

The percentage of participants achieving response in reduction of 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, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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).

The percentage of participants achieving overall response was defined as follows: \>= 2 points reduction in 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, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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).

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, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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).

Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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).

Proptosis is the protrusion of the eyeball. Exophthalmos means the same, and this term is usually used when describing proptosis due to Grave's disease. Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: 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).

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, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: 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).

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, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until Week 16

Population: Safety Analysis Set (SAF). Due to premature study discontinuation, only Plan A was conducted (no data collected for Plan B, as Plan B was not initiated).

Due to premature study discontinuation, only Plan A was conducted (Plan B was not initiated) for the secondary endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Secukinumab 300 mg (Double-blind)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo (Double-blind)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Any Secukinumab 300 mg (Entire Study)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Secukinumab 300 mg (Double-blind) n=14 participants at risk Secukinumab 300 mg (Double-blind): Double-blind treatment period (from first dose of study treatment until Week 16)	Placebo (Double-blind) n=14 participants at risk Secukinumab matching placebo (Double-blind): Double-blind treatment period (from first dose of study treatment until Week 16)	Any Secukinumab 300 mg (Entire Study) n=26 participants at risk All events reported from the beginning of the study up until the end of follow-up/open-label retreatment period (from first dose of study treatment up to Week 108)
Endocrine disorders Graves' disease	7.1% 1/14 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/14 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	3.8% 1/26 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Eye disorders Endocrine ophthalmopathy	0.00% 0/14 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	7.1% 1/14 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.	0.00% 0/26 • Adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 16) and for the follow-up/open-label re-treatment period, including AEs in follow up for all patients who received at least one dose of Secukinumab during the entire study up to a maximum of 108 weeks. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER