A Phase 3 interventional study of Secukinumab 300 mg, s.c. and Placebo to match Secukinumab, s.c. in Giant Cell Arteritis, sponsored by Novartis Pharmaceuticals. Completed at 25 sites in Germany. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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.
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.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's enrollment of 151 is above the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants eligible for inclusion in this study must meet all of the following criteria:
Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria:
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.
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study.
3. Participants not eligible for 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 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.
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. or 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 (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. within 6 weeks prior to BSL or planned live vaccination during study participation until 12 weeks after last study treatment administration.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Drug: Placebo to match Secukinumab, s.c.
Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Biological: Secukinumab 300 mg, s.c.
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.
Also known as: Cosentyx, AIN457
Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
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: 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.
Time frame: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24
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.
Time frame: 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)
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
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)
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)
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)
Time frame: 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
Time frame: 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
Time frame: Bseline to Week 52
Cumulative prednisolone or equivalent dose
Cumulative prednisolone or equivalent dose through Week 52
Time frame: 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
Time frame: Baseline up to 52 weeks
Plan to share: 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
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Feb 2026, 40 months.
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Studies of the drug tested here: Secukinumab