Long-Term Safety of Secukinumab for Autoimmune Inflammation
Recruiting in Palo Alto (17 mi)
+118 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Novartis Pharmaceuticals
Must be taking: Secukinumab
Disqualifiers: Discontinued treatment, Women of childbearing potential
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial focuses on participants who are already benefiting from secukinumab, it seems likely that you would continue with this medication.
What data supports the effectiveness of the drug Secukinumab?
Secukinumab has been shown to be effective in treating conditions like psoriatic arthritis and ankylosing spondylitis, improving symptoms and quality of life for patients. Clinical trials have demonstrated its ability to reduce disease signs and symptoms, and it is generally well tolerated with mild to moderate side effects.12345
How is the drug secukinumab different from other treatments for autoimmune inflammation?
Secukinumab is unique because it is the first drug in its class to target interleukin-17A, a protein involved in inflammation, making it different from other treatments that target different pathways. It is administered as an injection under the skin and has shown effectiveness in conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis, especially for patients who do not respond well to other treatments.12456
Research Team
NP
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for people who have benefited from Secukinumab in a previous Novartis study, can't get it commercially due to local guidelines, and are judged by the researcher to still benefit from it. It's not for those who stopped early in the earlier study or women able to have children not using contraception.Inclusion Criteria
Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
I have finished or benefited from secukinumab treatment in a Novartis study, not stopped for safety or efficacy issues.
I am benefiting from secukinumab treatment and my doctor agrees.
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Exclusion Criteria
I am using birth control as required if I can become pregnant.
Participant has prematurely discontinued study treatment in the parent protocol.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive secukinumab treatment based on their previous trial dosage, with potential dose adjustments based on clinical need
up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Participants continue to receive secukinumab treatment to assess long-term safety
up to 2 years
Treatment Details
Interventions
- Secukinumab (Monoclonal Antibodies)
Trial OverviewThe trial continues treatment with Secukinumab injections for patients previously on it, aiming to assess long-term safety. Participants must have completed an earlier Novartis trial and be unable to obtain the drug otherwise.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Secukinumab s.c.Experimental Treatment1 Intervention
Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
FL Medical Clinic Orlando Health .Zephyrhills, FL
Novartis Investigative SitePlantation, FL
Novartis Investigative SiteMiami, FL
Altoona Center for Clin Res .Duncansville, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Trials
2963
Patients Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
References
Secukinumab for the treatment of psoriatic arthritis. [2019]Secukinumab (Cosentyx) is an interleukin-17A (IL-17A) inhibitor administered subcutaneously. Through 2016, it had received approval in a number of countries, including the USA, Japan and in the EU for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Secukinumab: A Review in Psoriatic Arthritis. [2019]Secukinumab (Cosentyx(®)) is a high affinity, human monoclonal antibody targeted against interleukin (IL)-17A. It is the first-in-class anti-IL-17 agent, initially approved for the treatment of plaque psoriasis, and more recently for the treatment of ankylosing spondylitis and psoriatic arthritis. This article reviews the therapeutic efficacy of subcutaneous secukinumab in the treatment of psoriatic arthritis, as well as discussing the tolerability and pharmacological properties of the drug. Phase III clinical trial data demonstrated that, compared with placebo, subcutaneous secukinumab was efficacious in improving the signs and symptoms of psoriatic arthritis in patients with active disease despite previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or disease-modifying anti-rheumatic drugs (DMARDs). In addition, secukinumab treatment was associated with significant improvements in patient-reported measures of physical functioning and health-related quality of life. Secukinumab is generally well tolerated, with the most common adverse events being mild to moderate, non-serious infections, such as upper respiratory tract infections and nasopharyngitis. In conclusion, although longer-term and comparative data are lacking, current clinical data indicate that secukinumab is efficacious and well tolerated in the treatment of psoriatic arthritis, and it thus provides a useful treatment alternative to tumour necrosis factor inhibitors and other targeted DMARDs.
Secukinumab: A Review in Psoriatic Arthritis. [2021]Secukinumab (Cosentyx®) is a fully human monoclonal antibody that selectively targets interleukin (IL)-17A, a proinflammatory cytokine involved in the pathogenesis of psoriatic arthritis (PsA). Administered subcutaneously, the first-in-class anti-IL-17 agent is approved in numerous countries worldwide for the treatment of adults with active PsA. In the phase III FUTURE trials, secukinumab 150 or 300 mg improved the clinical signs and symptoms of PsA versus placebo in patients with active disease despite previous treatment with NSAIDs, biological disease-modifying anti-rheumatic drugs (bDMARDs) and/or tumour necrosis factor inhibitors (TNFi). The benefits of secukinumab were seen regardless of whether or not patients had received previous TNFi therapy, and were maintained during longer term (up to 5 years) treatment. In FUTURE 1 and 5, secukinumab inhibited structural joint damage and was associated with sustained low rates of radiographic progression through 1-3 years of treatment. Treatment with secukinumab improved physical function and health-related quality of life (HR-QOL) and was generally well tolerated, both in the short- and longer-term. In the head-to-head EXCEED trial, secukinumab did not quite attain statistical significance for superiority versus adalimumab in the joint domain. In conclusion, secukinumab is effective across all key PsA domains and is generally well tolerated, and thus represents a useful treatment alternative to TNFi and other bDMARDs in adult patients with active PsA.
Secukinumab: A Review in Ankylosing Spondylitis. [2019]Secukinumab (Cosentyx(®)) is a fully human monoclonal antibody against the proinflammatory cytokine interleukin-17A. It is the first drug in its class to be approved for use in patients with active ankylosing spondylitis (AS). This article reviews the efficacy and tolerability of secukinumab in this indication and briefly summarizes its pharmacology. In ongoing phase III trials, 16 weeks' treatment with subcutaneous secukinumab 150 mg was effective in terms of improving the clinical signs and symptoms of disease and health-related quality of life in patients with AS, with these improvements maintained during longer-term (up to 2 years) treatment. In subgroup analyses, secukinumab was effective both in tumour necrosis factor (TNF) inhibitor-naïve patients and in patients intolerant of or refractory to TNF inhibitors. Secukinumab was generally well tolerated, with a tolerability profile consistent with that seen previously in patients with plaque psoriasis. In the absence of head-to-head trials, the position of secukinumab with respect to TNF inhibitors remains to be fully determined. Nevertheless, secukinumab is an effective and generally well tolerated treatment option for patients with AS.
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.
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.