50 and older, any sex, with Giant Cell Arteritis. 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 in Sustained Remission Until Week 28Primary· Until week 28
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Basel
Group
Value
95% CI
Secukinumab
19
Placebo
6
Percentage of Participants in Remission at Week 12Secondary· Week 12
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of fl
Group
Value
95% CI
Secukinumab
22
Placebo
12
Time to First GCA Flare After Clinical RemissionSecondary· Up to Week 52 (included)
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.
For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and
Group
Value
95% CI
Secukinumab
NA
NA – NA
Placebo
197.0
101.0 – 280.0
Total Cumulative Prednisolone Dose Over 28 Weeks and 52 WeeksSecondary· from Baseline to week 28, from baseline to week 52 weeks
Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.
Baseline to Week 28
Group
Value
95% CI
Secukinumab
2689.70
± 935.860
Placebo
2693.74
± 1241.907
Baseline to Week 52
Group
Value
95% CI
Secukinumab
2841.26
± 1116.192
Placebo
3375.58
± 1720.978
Percentage of Participants With GCA Who Had Sustained Remission Until Week 52Secondary· Until Week 52
Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks o
Group
Value
95% CI
Secukinumab
16
Placebo
2
Number of Participants on Prednisolone Dose ≤ 5mg/DaySecondary· Week 19, Week 28, Week 52
Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dos
Week 19 (n = 25, 20)
Group
Value
95% CI
Secukinumab
22
Placebo
10
Week 28 (n = 23, 20)
Group
Value
95% CI
Secukinumab
19
Placebo
9
Week 52 (n = 21, 17)
Group
Value
95% CI
Secukinumab
19
Placebo
13
Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)Secondary· Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Week 4 (n = 27, 23)
Group
Value
95% CI
Secukinumab
-4.8
± 14.43
Placebo
-3.2
± 18.45
Week 8 (n = 26, 21)
Group
Value
95% CI
Secukinumab
-5.8
± 12.77
Placebo
2.1
± 18.94
Week 12 (n = 25, 20)
Group
Value
95% CI
Secukinumab
-3.4
± 21.93
Placebo
-3.1
± 10.81
Week 16 (n = 25, 20)
Group
Value
95% CI
Secukinumab
-4.1
± 15.62
Placebo
0.7
± 13.97
Week 20 (n = 24, 20)
Group
Value
95% CI
Secukinumab
-6.9
± 14.78
Placebo
-1.5
± 14.32
Week 24 (n = 23, 20)
Group
Value
95% CI
Secukinumab
-4.3
± 15.92
Placebo
2.2
± 17.22
Week 28 (23, 19)
Group
Value
95% CI
Secukinumab
-5.4
± 15.61
Placebo
3.9
± 21.47
Week 36 (21, 19)
Group
Value
95% CI
Secukinumab
-8.7
± 18.45
Placebo
0.7
± 17.45
Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)Secondary· Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Week 4 (n = 27, 23)
Group
Value
95% CI
Secukinumab
-15.8
± 28.17
Placebo
-0.5
± 23.58
Week 8 (n = 26, 21)
Group
Value
95% CI
Secukinumab
-15.8
± 27.61
Placebo
-10.8
± 27.64
Week 12 (n = 25, 20)
Group
Value
95% CI
Secukinumab
-8.0
± 29.43
Placebo
-11.9
± 31.46
Week 16 (n = 25, 20)
Group
Value
95% CI
Secukinumab
-18.6
± 19.39
Placebo
-8.8
± 31.43
Week 20 (n = 24, 20)
Group
Value
95% CI
Secukinumab
-19.18
± 30.68
Placebo
-6.9
± 31.94
Week 24 (n = 23, 20)
Group
Value
95% CI
Secukinumab
-14.9
± 28.84
Placebo
-7.0
± 30.61
Week 28 (n = 23, 19)
Group
Value
95% CI
Secukinumab
-14.4
± 25.46
Placebo
-8.0
± 31.31
Week 36 (n = 21, 19)
Group
Value
95% CI
Secukinumab
-20.9
± 22.31
Placebo
-8.6
± 29.90
Change From Baseline in FACIT-Fatigue ScaleSecondary· Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).
Week 4 (n = 27, 23)
Group
Value
95% CI
Secukinumab
2.11
± 9.613
Placebo
-0.96
± 7.358
Week 8 (n = 26, 21)
Group
Value
95% CI
Secukinumab
2.19
± 10.190
Placebo
0.81
± 7.498
Week 12 (n = 25, 20)
Group
Value
95% CI
Secukinumab
0.96
± 11.175
Placebo
-0.25
± 10.047
Week 16 (n = 25, 20)
Group
Value
95% CI
Secukinumab
2.12
± 8.876
Placebo
-0.36
± 8.884
Week 20 (n =24, 20)
Group
Value
95% CI
Secukinumab
3.42
± 8.617
Placebo
0.05
± 10.318
Week 24 (n = 23, 20)
Group
Value
95% CI
Secukinumab
2.91
± 10.409
Placebo
-3.10
± 11.281
Week 28 (n = 23, 19)
Group
Value
95% CI
Secukinumab
3.61
± 11.044
Placebo
0.42
± 9.203
Week 36 (n = 21, 19)
Group
Value
95% CI
Secukinumab
3.90
± 7.245
Placebo
1.84
± 8.719
Change From Baseline in Short-Form (SF)-36 QuestionnaireSecondary· Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.
EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, \& anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" \& 0 represents the "worst p
EQ-5D-5L VAS: Week 4 (n = 27, 23)
Group
Value
95% CI
Secukinumab
11.26
± 16.819
Placebo
1.87
± 21.467
EQ-5D-5L VAS: Week 8 (n = 26, 21)
Group
Value
95% CI
Secukinumab
5.58
± 16.650
Placebo
5.52
± 29.646
EQ-5D-5L VAS: Week 12 (n = 25, 20)
Group
Value
95% CI
Secukinumab
4.64
± 19.598
Placebo
3.30
± 22.850
EQ-5D-5L VAS: Week 16 (n = 25, 20)
Group
Value
95% CI
Secukinumab
7.000
± 19.530
Placebo
4.40
± 27.354
EQ-5D-5L VAS: Week 20 (n = 24, 20)
Group
Value
95% CI
Secukinumab
7.88
± 19.077
Placebo
6.30
± 25.041
EQ-5D-5L VAS: Week 24 (n = 23, 20)
Group
Value
95% CI
Secukinumab
5.39
± 17.598
Placebo
-1.00
± 29.902
EQ-5D-5L VAS: Week 28 (n = 23, 19)
Group
Value
95% CI
Secukinumab
4.43
± 17.840
Placebo
10.37
± 21.670
WEQ-5D-5L VAS: Week 36 (n = 21, 19)
Group
Value
95% CI
Secukinumab
6.90
± 17.972
Placebo
5.32
± 28.825
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)Secondary· Baseline, Week 28, Week 52
ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Week 28 (n = 23, 18)
Group
Value
95% CI
Secukinumab
4.043
± 16.1934
Placebo
14.667
± 23.9141
Week 52 (n = 21, 16)
Group
Value
95% CI
Secukinumab
-3.286
± 10.6167
Placebo
10.000
± 14.8728
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Secukinumab
Serious: 6/27 (22%)
Deaths: 1/27
Placebo
Serious: 11/25 (44%)
Deaths: 1/25
All Participants
Serious: 17/52 (33%)
Deaths: 2/52
Serious adverse events (35 terms)
Reaction
System
Secukinumab
Placebo
All Participants
Cardiac failure
Cardiac disorders
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
Pelvic fracture
Injury, poisoning and procedural complications
—
—
—
Spinal stenosis
Musculoskeletal and connective tissue disorders
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Atrial tachycardia
Cardiac disorders
—
—
—
Tachyarrhythmia
Cardiac disorders
—
—
—
Faecaloma
Gastrointestinal disorders
—
—
—
Gastrointestinal pain
Gastrointestinal disorders
—
—
—
Melaena
Gastrointestinal disorders
—
—
—
Noninfective sialoadenitis
Gastrointestinal disorders
—
—
—
General physical health deterioration
General disorders
—
—
—
Pyrexia
General disorders
—
—
—
Arthritis bacterial
Infections and infestations
—
—
—
Erysipelas
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Face injury
Injury, poisoning and procedural complications
—
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
—
Fibula fracture
Injury, poisoning and procedural complications
—
—
—
Spinal compression fracture
Injury, poisoning and procedural complications
—
—
—
Inflammatory marker increased
Investigations
—
—
—
Fluid retention
Metabolism and nutrition disorders
—
—
—
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who were naïve to biological therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05380453 — Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
· Phase 3
· completed
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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 Novartis Pharmaceuticals
Last refreshed: 21 August 2023
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/NCT03765788.