2024-512856-40-00招募中3 期
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 glucocorticoidmonotherapy (GigAINt)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 30
- 主要终点
- Time from baseline to first GCA clinical relapse
研究概览
简要总结
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 in patients with new-onset GCA who are in clinical remission and eligible for treatment with glucocorticoid-monotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •Participants with no relapsing GCA at BSL
- •Prednisolone or equivalent dose (oral) of 20-60 mg/day or equivalent dose of other glucocorticoids (GCs) at BSL
排除标准
- •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.
- •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.
- •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 treated with an alkylating agent within 5 years prior to Baseline, unless specified in other exclusion criteria.
- •Participants requiring systemic chronic glucocorticoid therapy for any other reason than GCA at Screening.
- •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.
- •Active ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis.
- •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.
- •Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor.
- •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.
- •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.
- •Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
- •Active systemic infections during the last 2 weeks (exception: common cold) prior to BSL.
- •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.
- •Live vaccinations within 6 weeks prior to BSL or planned live vaccination during study participation until 12 weeks after last study treatment administration.
- •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
- •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.
结局指标
主要结局
Time from baseline to first GCA clinical relapse
Time from baseline to first GCA clinical relapse
次要结局
- Proportion of participants in sustained clinical remission at Week 52
- Efficacy endpoints: - Changes from Baseline to Week 52 in disease activity and quality of life for each of the following: PGA score (VAS), SF-36 (PCS and MCS) score, Patient assessment of pain (NRS) and other assessments - Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day - Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day at Week 52 - Cumulative prednisolone or equivalent dose through Week 52
- Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters
研究者
Medizinischer Infoservice (MCC)
Scientific
Novartis Pharma GmbH
研究点 (30)
Loading locations...
相似试验
已完成
3 期
Study of efficacy and safety of secukinumab in participants with moderate-severe rotator cuff tendinopathy2022-502080-38-00Novartis Pharma AG128
已完成
2 期
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisGiant Cell ArteritisNCT03765788Novartis Pharmaceuticals52
进行中（未招募）
3 期
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)Giant Cell Arteritis (GCA)NCT04930094Novartis Pharmaceuticals355
已完成
3 期
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)Polymyalgia RheumaticaNCT05767034Novartis Pharmaceuticals381
已完成
3 期
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritisSpondyloarthritisNCT03136861Novartis Pharmaceuticals383