Giant Cell ArteritisPhase 3GigAINtNCT05380453
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
A Phase 3 study testing Secukinumab 300 mg, s.c. in people with Giant Cell Arteritis, run by Novartis Pharmaceuticals at 25 sites in Germany.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Secukinumab 300 mg, s.c.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 25 sitesGermany
- Study dates
- 29 Sep 2022to 24 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Male or female participants at least 50 years of age.
- Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria:
- Age at onset of disease ≥50 years.
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- History of Erythrocyte Sedimentation Rate (ESR) ≥30 mm/hr or C-reactive protein (CRP) ≥10 mg/L attributable to active GCA.
- Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) AND/OR symptoms of limb ischemia (claudication).
- Temporal artery biopsy revealing features of GCA AND/OR evidence of vasculitis in cranial or extracranial arteries by angiography or cross-sectional imaging study such as ultrasound, magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography - computed tomography (PET-CT)
- Participants must be in clinical remission at BSL:
- Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.
- Participants with no relapsing GCA at BSL:
- Definition of relapsing GCA: occurrence of clinical relapse after clinical remission.
- Prednisolone or equivalent dose (oral) of 20-60 mg/day or equivalent dose of other glucocorticoids (GCs) at BSL.
Who cannot join
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- 3. Participants not eligible for glucocorticoid monotherapy due to known increased risk for or presence of GC-related adverse-effects or complications and/or intolerance to GCs, such as osteoporosis, diabetes mellitus, cardiovascular disease and glaucoma as assessed at the investigator's discretion (see Appendix 15.2).
- 4. Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor.
- 5. Participants treated with any cell-depleting therapies including but not limited to anti- CD20 or investigational agents (e.g., anti-CD3, anti-CD4, anti-CD5 or anti-CD19).
- 6. Previous participation in clinical trials for GCA 7. Participants who have been treated with inhibitors directly targeting IL-12 and/or IL-23 (such as ustekinumab, guselkumab, tildrakizumab, risankizumab), IL-1 or IL-1 receptor (such as anakinra or canakinumab), or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
- 8. Treatment with tocilizumab, other IL-6/IL6-R inhibitor or JAK inhibitor within 12 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or if participant did not respond to or experienced a clinical relapse during treatment any time before BSL.
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- 9. Any treatment received for GCA other than GCs and participant did not respond to treatment or experienced a clinical relapse during treatment any time before BSL.
- 10. Any other biologics within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
- 11. Participants treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
- 12. Participants treated with cyclophosphamide, tacrolimus, everolimus hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 6 months prior to BSL.
- 13. Participants treated with methotrexate (MTX), within 4 weeks prior to BSL. 14. Participants treated with leflunomide within 8 weeks prior to BSL unless a cholestyramine washout has been performed in which case the participant must be treated within 4 weeks of BSL.
- 15. Participants treated with an alkylating agent within 5 years prior to Baseline, unless specified in other exclusion criteria.
- 16. Participants requiring systemic chronic glucocorticoid therapy for any other reason than GCA at Screening.
- 17. Receipt of > 100 mg daily intravenous methylprednisolone pulse therapy within 6 weeks prior to BSL.
- 18. Participants requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management.
- 19. Participants treated with any investigational agent within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
- 20. Contraindication or hypersensitivity to secukinumab. 21. Active ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis.
- 22. Active ongoing diseases which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy.
- 23. Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunocomprises the participant and/or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
- 24. Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) (except ischemia-related vision loss), related or unrelated to GCA, within 12 weeks of screening.
- 25. Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
- 26. Active systemic infections during the last 2 weeks (exception: common cold) prior to BSL.
- 32. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Plus test. Participants with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the participant has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local country guidelines must be initiated prior to BSL.
- 35. Live vaccinations within 6 weeks prior to BSL or planned live vaccination during study participation until 12 weeks after last study treatment administration.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites
Novartis Investigative Site
Bad Abbach, 93077
Novartis Investigative Site
Bad Nauheim, 61231
Novartis Investigative Site
Berlin, 12161
Novartis Investigative Site
Berlin, 12435
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 51149
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Dresden, 01067
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, 40225
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Gommern, 39245
Novartis Investigative Site
Göttingen, Lower Saxony, 37075
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Ludwigshafen, 67063
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Minden, 32429
Novartis Investigative Site
München, 81667
Novartis Investigative Site
Rendsburg, 24768
Novartis Investigative Site
Sendenhorst, 48324
Novartis Investigative Site
Trier, 54292
Novartis Investigative Site
Würzburg, Bavaria, 97080
About this study
Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapy
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.
Read the detailed description
Recent scientific evidence identified an association between polymorphisms within the IL-17A locus and GCA, supporting a role for IL-17A in vasculitis pathophysiology. Analysis of the inflammatory processes in the aortic wall has indicated that inflammatory cytokines, such as IL-6 and IL-17A are involved in GCA pathogenesis. Elevated IL-17A mRNA levels are correlated with IL-6 and IL-23p19 mRNA levels indicating the involvement of the IL-23/Th17 axis in GCA. With its pleiotropic activity on many different cell types, IL-17A may actively contribute to the inflammatory processes in GCA. In addition, animal studies also support a role of IL-17A as a driver of vasculitis, since mice deficient in IRF-4 binding protein, which have increased IL-21 and IL-17A expression, spontaneously develop arthritis-like joint disease and large vessel vasculitis (LVV).
As secukinumab has already demonstrated a positive benefit/risk profile in the treatment of multiple chronic inflammatory diseases, including PsO, PsA and axSpA, and based on the scientific rationale for targeting the IL-17 pathway in GCA as well as on the basis of the currently ongoing Phase 2 Proof-of-Concept trial the which evaluates the efficacy, safety and tolerability of 300 mg secukinumab compared to placebo, in combination with a 26-week prednisolone taper regimen in adult subjects with GCA (EudraCT number: 2018-002610-12) (Venhoff, et al., 2021), inhibition of IL-17A by secukinumab has a potential therapeutic benefit for GCA patients.
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.
- Conditions
- Giant Cell Arteritis
- Being tested
- Secukinumab 300 mg, s.c., Placebo to match Secukinumab, s.c.
- Keywords
- Giant Cell Arteritis, GCA, Vasculitis, Vascular Diseases, Secukinumab, Subcutaneous, Vessel Inflammation, Polymyalgia Rheumatica, Arteritis
- Medical subject headings
- Giant Cell Arteritis, Vasculitis, Vascular Diseases, Polymyalgia Rheumatica, Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 300 mg, s.c.Biological
Also called Cosentyx, AIN457
Secukinumab will be administered at a dose of 300 mg as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Placebo to match Secukinumab, s.c.Drug
Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. Receives: Drug: Placebo to match Secukinumab, s.c. |
| Secukinumab | Experimental | Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. Receives: Biological: Secukinumab 300 mg, s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from baseline to first Giant cell arteritis (GCA) clinical relapse
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo (both arms in combination with a prednisolone or equivalent taper regimen as per treatment guideline) in delaying the time to first GCA clinical relapse from baseline in participants with new onset of GCA who are in clinical remission and eligible for treatment with glucocorticoid-monotherapy.
GCA clinical relapse is defined as both:
- The recurrence of signs or symptoms attributable to active GCA after clinical remission, which are considered clinically significant by the investigator AND
- The requirement of a change in the treatment prompted by the recurrence of signs and symptoms i. an increase in prednisolone or equivalent dose AND/OR ii. the addition of a rescue treatment.
Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.
Measured: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24
Secondary outcomes (8)
Proportion of participants in sustained clinical remission at Week 52
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo, measured by the proportion of participants in sustained clinical remission at Week 52.
Definition of sustained clinical remission: absence of signs and symptoms attributable to active GCA between BSL until Week 52.
Measured: Baseline until Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for the PGA score (VAS)
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient global assessment (PGA) of disease activity using a visual analogue scale (VAS)
Measured: Baseline to Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for the SF-36 (PCS and MCS) score
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for Short form 36 (SF-36 PCS and MCS)
Measured: Baseline to Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for Patient assessment of pain (NRS)
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient assessment of pain using a numeric rating scale (NRS)
Measured: Baseline to Week 52
Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day
Time to reach prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Measured: Baseline to Week 52
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Measured: Bseline to Week 52
Cumulative prednisolone or equivalent dose
Cumulative prednisolone or equivalent dose through Week 52
Measured: Baseline through Week 52
Number of participants with Adverse Events
Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters
To evaluate safety and tolerability of secukinumab 300 mg s.c. in participants with new-onset of GCA who are eligible for treatment with glucocorticoid-monotherapy
Measured: Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start29 Sep 2022
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380453
- Sponsor's protocol ID
- CAIN457R1DE01
- Other IDs
- 2021-002622-24
- Acronym
- GigAINt
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapy
- ClinicalTrials.gov ID
- NCT05380453
- Acronym / sponsor ID
- GigAINt / CAIN457R1DE01
- Conditions
- Giant Cell Arteritis
- Keywords
- Giant Cell Arteritis, GCA, Vasculitis, Vascular Diseases, Secukinumab, Subcutaneous, Vessel Inflammation, Polymyalgia Rheumatica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.
Detailed description
Recent scientific evidence identified an association between polymorphisms within the IL-17A locus and GCA, supporting a role for IL-17A in vasculitis pathophysiology. Analysis of the inflammatory processes in the aortic wall has indicated that inflammatory cytokines, such as IL-6 and IL-17A are involved in GCA pathogenesis. Elevated IL-17A mRNA levels are correlated with IL-6 and IL-23p19 mRNA levels indicating the involvement of the IL-23/Th17 axis in GCA. With its pleiotropic activity on many different cell types, IL-17A may actively contribute to the inflammatory processes in GCA. In addition, animal studies also support a role of IL-17A as a driver of vasculitis, since mice deficient in IRF-4 binding protein, which have increased IL-21 and IL-17A expression, spontaneously develop arthritis-like joint disease and large vessel vasculitis (LVV).
As secukinumab has already demonstrated a positive benefit/risk profile in the treatment of multiple chronic inflammatory diseases, including PsO, PsA and axSpA, and based on the scientific rationale for targeting the IL-17 pathway in GCA as well as on the basis of the currently ongoing Phase 2 Proof-of-Concept trial the which evaluates the efficacy, safety and tolerability of 300 mg secukinumab compared to placebo, in combination with a 26-week prednisolone taper regimen in adult subjects with GCA (EudraCT number: 2018-002610-12) (Venhoff, et al., 2021), inhibition of IL-17A by secukinumab has a potential therapeutic benefit for GCA patients.
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to match Secukinumab, s.c.Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. |
| Secukinumab | Experimental | Biological: Secukinumab 300 mg, s.c.Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Male or female participants at least 50 years of age.
- Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria:
Key exclusion criteria (24 listed)
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- 3. Participants not eligible for glucocorticoid monotherapy due to known increased risk for or presence of GC-related adverse-effects or complications and/or intolerance to GCs, such as osteoporosis, diabetes mellitus, cardiovascular disease and glaucoma as assessed at the investigator's discretion (see Appendix 15.2).
- 4. Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor.
- 5. Participants treated with any cell-depleting therapies including but not limited to anti- CD20 or investigational agents (e.g., anti-CD3, anti-CD4, anti-CD5 or anti-CD19).
- 6. Previous participation in clinical trials for GCA 7. Participants who have been treated with inhibitors directly targeting IL-12 and/or IL-23 (such as ustekinumab, guselkumab, tildrakizumab, risankizumab), IL-1 or IL-1 receptor (such as anakinra or canakinumab), or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab 300 mg, s.c.Also: Cosentyx, AIN457Secukinumab will be administered at a dose of 300 mg as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. | Biological | Secukinumab |
| Placebo to match Secukinumab, s.c.Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter. | Drug | Placebo |
Primary outcome
Time from baseline to first Giant cell arteritis (GCA) clinical relapse
Time frame: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo (both arms in combination with a prednisolone or equivalent taper regimen as per treatment guideline) in delaying the time to first GCA clinical relapse from baseline in participants with new onset of GCA who are in clinical remission and eligible for treatment with glucocorticoid-monotherapy. GCA clinical relapse is defined as both: 1. The recurrence of signs or symptoms attributable to active GCA after clinical remission, which are considered clinically significant by the investigator AND 2. The requirement of a change in the treatment prompted by the recurrence of signs and symptoms i. an increase in prednisolone or equivalent dose AND/OR ii. the addition of a rescue treatment. Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.
8 secondary outcomes
Proportion of participants in sustained clinical remission at Week 52
Time frame: Baseline until Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for the PGA score (VAS)
Time frame: Baseline to Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for the SF-36 (PCS and MCS) score
Time frame: Baseline to Week 52
Changes from Baseline to Week 52 in disease activity and quality of life for Patient assessment of pain (NRS)
Time frame: Baseline to Week 52
Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day
Time frame: Baseline to Week 52
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Time frame: Bseline to Week 52
Cumulative prednisolone or equivalent dose
Time frame: Baseline through Week 52
Number of participants with Adverse Events
Time frame: Baseline up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab 300 mg, s.c. in people with Giant Cell Arteritis, run by Novartis Pharmaceuticals at 25 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from baseline to first Giant cell arteritis (GCA) clinical relapse (time frame: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.