Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

NCT05380453 | Completed Phase 3

• 2 other identifiers: CAIN457R1DE012021-002622-24
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 25

Brief 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 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

Keywords

Giant Cell Arteritis; GCA; Vasculitis; Vascular Diseases; Secukinumab; Subcutaneous; Vessel Inflammation; Polymyalgia Rheumatica; Arteritis

Outcome Measures

Primary Outcomes (1)

• 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 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

  Baseline until Week 52

• Changes from Baseline to Week 52 in disease activity and quality of life for the PGA score (VAS)

  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

  Baseline to Week 52

• Changes from Baseline to Week 52 in disease activity and quality of life for Patient assessment of pain (NRS)

  Baseline to Week 52

• Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day

  Baseline to Week 52

Study Arms (2)

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.

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.

Biological: Secukinumab 300 mg, s.c.

Interventions

Secukinumab 300 mg, s.c. BIOLOGICAL

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

Secukinumab

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.

Placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \. 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).
• \. Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor.
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. Any other biologics within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
• \. Participants treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
• \. Participants treated with cyclophosphamide, tacrolimus, everolimus hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 6 months prior to BSL.
• \. 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.
• \. Participants requiring systemic chronic glucocorticoid therapy for any other reason than GCA at Screening.
• \. Receipt of \> 100 mg daily intravenous methylprednisolone pulse therapy within 6 weeks prior to BSL.
• \. Participants requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management.
• \. Participants treated with any investigational agent within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
• \. 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (25)

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

Location

Novartis Investigative Site

Göttingen, Lower Saxony, 37075, Germany

Location

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

Location

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

Location

Novartis Investigative Site

Bad Abbach, 93077, Germany

Location

Novartis Investigative Site

Bad Nauheim, 61231, Germany

Location

Novartis Investigative Site

Berlin, 12161, Germany

Location

Novartis Investigative Site

Berlin, 12435, Germany

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Cologne, 51149, Germany

Location

Novartis Investigative Site

Dresden, 01067, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Gommern, 39245, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67063, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Minden, 32429, Germany

Location

Novartis Investigative Site

München, 81667, Germany

Location

Novartis Investigative Site

Rendsburg, 24768, Germany

Location

Novartis Investigative Site

Sendenhorst, 48324, Germany

Location

Novartis Investigative Site

Trier, 54292, Germany

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Vasculitis; Vascular Diseases; Polymyalgia Rheumatica; Arteritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: May 18, 2022
• Study Start: September 29, 2022
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (25)