Secukinumab for Giant Cell Arteritis and Polymyalgia Rheumatica
Recruiting in Palo Alto (17 mi)
+38 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics \[PK\]) and whether it will be safe and tolerable after multiple doses of i.v. Secukinumab infusion in adult patients with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR).
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that you cannot use other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer. It's best to discuss your current medications with the trial investigators.
What data supports the idea that Secukinumab for Giant Cell Arteritis and Polymyalgia Rheumatica is an effective drug?
The available research does not provide specific data on the effectiveness of Secukinumab for treating Giant Cell Arteritis and Polymyalgia Rheumatica. Instead, it mentions other drugs like tocilizumab and ustekinumab, which have shown effectiveness in reducing the need for steroids and lowering relapse rates in these conditions. Tocilizumab, in particular, has been studied in large groups and found to be effective and safe for Giant Cell Arteritis. Therefore, while Secukinumab is not specifically mentioned, other similar drugs have shown promise in treating these conditions.
12345What safety data is available for Secukinumab?
Secukinumab, also known as Cosentyx or AIN457, has been evaluated for safety in various conditions such as rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Studies indicate that it generally has a favorable safety profile, with common adverse events including nasopharyngitis, upper respiratory infections, headache, and injection site reactions. However, adverse events of special interest (AESI) like inflammatory bowel disease, eczematous drug eruption, drug-associated vasculitis, and drug-induced lupus erythematosus have been reported, mostly mild to moderate and resolving after discontinuation. Long-term studies, such as a four-year study in ankylosing spondylitis, support its sustained safety.
678910Eligibility Criteria
Adults over 50 with Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR), experiencing symptoms like severe headaches, vision loss, jaw pain when eating, and morning stiffness. Participants must have signs of active GCA not due to past damage and no other joint issues. They should also test negative for certain arthritis markers and show evidence of vasculitis on medical imaging or a temporal artery biopsy.Participant Groups
The trial is testing the safety and how well the body handles multiple doses of Secukinumab given through an IV in patients with GCA or PMR. It will track how the drug moves through and exits the body, as well as its tolerability after repeated infusions.
2Treatment groups
Experimental Treatment
Group I: Secukinumab: Polymyalgia Rheumatica (PMR)Experimental Treatment1 Intervention
Group II: Secukinumab: Giant Cell Arteritis (GCA)Experimental Treatment1 Intervention
Secukinumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Cosentyx for:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Non-radiographic axial spondyloarthritis
🇺🇸 Approved in United States as Cosentyx for:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Non-radiographic axial spondyloarthritis
- Hidradenitis suppurativa
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Inspire Santa Fe Medical Group RheumatologySanta Fe, NM
West Tennessee Research InstituteJackson, TN
Stryde Research-Allen ArthritisAllen, TX
Accurate Clinical Research, Inc .San Antonio, TX
More Trial Locations
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
References
Treat-to-target recommendations in giant cell arteritis and polymyalgia rheumatica. [2023]To develop treat-to-target (T2T) recommendations in giant cell arteritis (GCA) and polymyalgia rheumatica (PMR).
[Management of polymyalgia rheumatica and large vessel vasculitis]. [2018]Imaging methods, such as joint and color duplex sonography, magnetic resonance imaging (MRI) and positron emission tomography (PET) nowadays facilitate the diagnosis of polymyalgia rheumatica and large vessel vasculitides and have now been included in the new classification criteria. In patients with typical symptoms, color duplex sonography of the temporal artery can replace a biopsy of the temporal artery for the diagnosis of giant cell arteritis (GCA); however, the role of these methods for patient follow-up and assessment of prognosis is unclear. Polymyalgia rheumatica is treated with glucocorticoids (GC) in an initial dosage of up to 20 mg per day. In patients with large vessel vasculitis higher doses are needed for induction of remission. Furthermore, the rate of relapse and GC-related adverse events are higher in GCA and Takayasu arteritis (TA). Thus, initial GC-sparing treatment with methotrexate or other immunosuppressants is recommended. Recent study data show an effectiveness of biologics. Recent data of the first placebo-controlled proof of concept trials showed that the interleukin-6 antagonist tocilizumab reduces GC requirements and relapse rates in patients with GCA and polymyalgia rheumatica. Both ustekinumab, a monocalonal antibody against interleukin-12/23p40 and the CTLA-4 immunoglobulin abatacept appeared to be effective in recent pilot trials for GCA. Antibodies against tumor necrosis factor alpha (TNF alpha) were ineffective for polymyalgia rheumatica and GCA in placebo-controlled trials but data from open label studies suggested some efficacy in refractory TA.
Relapse Risk and Safety of Long-Term Tocilizumab Use Among Patients With Giant Cell Arteritis: A Single-Enterprise Cohort Study. [2023]To evaluate the safety and efficacy of tocilizumab (TCZ) in giant cell arteritis (GCA) in a large North American cohort.
Ustekinumab for the Treatment of Giant Cell Arteritis. [2021]To evaluate the efficacy and safety of ustekinumab (UST) in giant cell arteritis (GCA).
Evidence on treat to target strategies in polymyalgia rheumatica and giant cell arteritis: a systematic literature review. [2023]To inform an international task force about current evidence on Treat to Target (T2T) strategies in Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA).
Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. [2020]To address the efficacy and safety of secukinumab in comparison with placebo in active rheumatoid arthritis (RA) patients who had an inadequate response to tumor necrosis factor (TNF) inhibitors.
One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. [2019]To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis.
Review of secukinumab-induced adverse events of special interest and its potential pathogenesis. [2022]Although secukinumab has demonstrated high efficacy and favorable safety in moderate-to-severe psoriasis and psoriatic arthritis, patients developing adverse events of special interest (AESI) were reported increasingly in real-world practice. A systematic literature search of the PubMed database was conducted to identify clinical studies or case reports on secukinumab-induced AESI. More than 1077 patients (aged 18-74 years) from 55 studies were reported to have 24 AESI 3 days to 96 weeks after secukinumab treatment. The four most common AESI was inflammatory bowel disease (n > 1000), eczematous drug eruption (n > 30), drug-associated vasculitis (n = 8), and drug-induced lupus erythematosus (n = 4). Most of these AESI were only mild to moderately severe and resolved after secukinumab discontinuation without or with symptomatic treatment. Secukinumab has the potential to develop a number of AESI by probably dysregulating the different expression of polar T-cell axes (Th1, Th2, Th17, Th22, and/or Treg) and driving various cytokines in some patients. Physicians should be aware of these AESI for timely diagnosis and proper treatment.
Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1. [2021]To present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study.
Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature. [2019]While there are several commercially available treatment options for psoriasis and psoriatic arthritis, there remains a large number of individuals who are refractory to current modalities. In the recent past, there has been increasing evidence that interleukin (IL)-17 plays a vital role in the pathophysiology of psoriasis. Preclinical, phase II, and phase III studies of secukinumab (Cosentyx®) targeting IL-17 and its receptor have thus far proved to be promising. We reviewed the results of phase II and phase III clinical trials for secukinumab in the treatment of psoriasis and psoriatic arthritis. Only published studies were considered in the present review. We also performed an English language literature search from January 2003 to September 2015 using PubMed with any of the following key words: (secukinumab OR AIN457) AND (psoriasis OR psoriatic arthritis). In our review of the literature, seven phase III and five phase II clinical trials, as well as open-label extension studies with unpublished findings were found. Results from phase III clinical trials indicated secukinumab to be efficacious and safe for the treatment of psoriasis and psoriatic arthritis according to Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) scores. The safety profile of this agent was similar across all studies, with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, headache, and injection site reaction. Secukinumab demonstrates rapid and robust clinical improvement accompanied by a favorable short- term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis and psoriatic arthritis treatment. Additional extension studies of lower level evidence are needed to further understand the safety profile of the drug.
Tocilizumab for induction and maintenance of remission in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. [2022]Giant cell arteritis is an immune-mediated disease of medium and large-sized arteries that affects mostly people older than 50 years of age. Treatment with glucocorticoids is the gold-standard and prevents severe vascular complications but is associated with substantial morbidity and mortality. Tocilizumab, a humanised monoclonal antibody against the interleukin-6 receptor, has been associated with rapid induction and maintenance of remission in patients with giant cell arteritis. We therefore aimed to study the efficacy and safety of tocilizumab in the first randomised clinical trial in patients with newly diagnosed or recurrent giant cell arteritis.
Efficacy and safety of secukinumab in patients with giant cell arteritis: study protocol for a randomized, parallel group, double-blind, placebo-controlled phase II trial. [2021]One key pathological finding in giant cell arteritis (GCA) is the presence of interferon-gamma and interleukin (IL)-17 producing T helper (Th) 1 and Th17 cells in affected arteries. There is anecdotal evidence of successful induction and maintenance of remission with the monoclonal anti-IL-17A antibody secukinumab. Inhibition of IL-17A could therefore represent a potential new therapeutic option for the treatment of GCA.
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis. [2021]To evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).