Long-Term Safety of Secukinumab for Autoimmune Inflammation

Recruiting at 122 trial locations

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Novartis Pharmaceuticals

Must be taking: Secukinumab

Disqualifiers: Discontinued treatment, Women of childbearing potential

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

715 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the long-term safety of secukinumab (also known as Cosentyx or AIN457) for individuals using it to treat autoimmune inflammation, such as psoriasis or rheumatoid arthritis. The researchers aim to ensure its safety for long-term use, particularly for those unable to access the standard version of the medication. It targets individuals who participated in a previous trial with secukinumab, found it beneficial, and cannot obtain it otherwise. For those who benefited from secukinumab in a past study and can no longer access it, this trial may be suitable. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for secukinumab?

Research has shown that secukinumab is safe for use. In studies lasting up to five years, it did not cause any major safety problems. Even after nine years, it remained safe, supporting its use for long-term treatment. These long-term studies found no new safety issues, suggesting that patients tolerate secukinumab well over time. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Secukinumab is unique because it targets interleukin-17A (IL-17A), a protein involved in the inflammatory process of autoimmune diseases, setting it apart from many current treatments that focus on other pathways, like tumor necrosis factor (TNF) inhibitors. This specific targeting can potentially lead to more effective control of inflammation with fewer side effects. Researchers are excited about secukinumab because it offers a new approach to managing autoimmune inflammation, with promising results in reducing symptoms and improving quality of life for patients. Additionally, secukinumab is administered via a convenient subcutaneous injection, which can be easier for patients compared to intravenous options.

What is the effectiveness track record for secukinumab in treating autoimmune inflammation?

Research has shown that secukinumab effectively treats several autoimmune diseases. Studies have found that it reduces symptoms in conditions like psoriasis and psoriatic arthritis, with many patients experiencing relief. In trials, 61.5% of patients with specific types of arthritis showed significant improvement after six months of treatment. The treatment acts quickly, and its effects are long-lasting. Overall, secukinumab is recognized for its effectiveness and safety in managing autoimmune conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am using birth control as required if I can become pregnant.

Participant has prematurely discontinued study treatment in the parent protocol.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Secukinumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Secukinumab s.c. Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Secukinumab, a monoclonal antibody targeting interleukin-17A, has been shown to significantly improve symptoms and quality of life in patients with active ankylosing spondylitis after 16 weeks of treatment, with benefits maintained for up to 2 years.

The drug is well tolerated and effective in both patients who have never used TNF inhibitors and those who have not responded to or cannot tolerate them, making it a promising treatment option for a diverse group of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Ankylosing Spondylitis. Blair, HA., Dhillon, S.[2019]

Secukinumab, a monoclonal antibody targeting IL-17A, has shown significant efficacy in improving symptoms of psoriatic arthritis in Phase III clinical trials, even in patients who had previously not responded to other treatments like NSAIDs or DMARDs.

The treatment is generally well tolerated, with mild to moderate infections being the most common side effects, making it a viable alternative to existing therapies such as tumor necrosis factor inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. Shirley, M., Scott, LJ.[2019]

Secukinumab is an effective treatment for psoriatic arthritis (PsA), showing improvements in skin symptoms, enthesitis, dactylitis, and preventing the progression of joint damage, based on clinical studies.

The treatment is generally well tolerated, with common side effects including nasopharyngitis, headache, and upper respiratory infections, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. Baronaite Hansen, R., Kavanaugh, A.[2019]

In a 52-week study involving 237 patients with rheumatoid arthritis, those treated with 150 mg of secukinumab showed sustained improvements in disease activity scores from Week 20 to Week 52, indicating its long-term efficacy.

The safety profile of secukinumab remained consistent over the study period, with a 64.8% rate of adverse events, mostly mild to moderate, and no deaths reported, suggesting it is a relatively safe option for patients who do not respond to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. Genovese, MC., Durez, P., Richards, HB., et al.[2019]

Secukinumab, an IL-17 inhibitor, has shown significant efficacy and safety in treating psoriasis and psoriatic arthritis, based on results from seven phase III and five phase II clinical trials involving various patient populations.

The treatment led to rapid clinical improvement, with a favorable safety profile, where common side effects included nasopharyngitis and upper respiratory infections, indicating it is a promising option for patients who do not respond to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature. Abrouk, M., Gandy, J., Nakamura, M., et al.[2019]

Secukinumab, a monoclonal antibody targeting IL-17A, has been shown to significantly improve symptoms of psoriatic arthritis (PsA) in patients who have not responded to previous treatments, with benefits maintained for up to 5 years.

In clinical trials, secukinumab effectively inhibited structural joint damage and improved physical function and quality of life, demonstrating its safety and efficacy as a treatment option for active PsA compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. Blair, HA.[2021]

Citations

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Secukinumab for rheumatology: development and its ... Data from both the MEASURE trials also indicated that secukinumab was associated with a reduction of spinal inflammation as assessed by magnetic resonance ...

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Secukinumab: The Latest in Autoimmune Treatment and ... Effectiveness and Benefits: Studies show secukinumab can reduce symptoms in autoimmune diseases, with many patients seeing improvements within ...

3. jrheum.org jrheum.org/content/52/8/829

Access, Effectiveness, Safety, and Survival of ... Effectiveness of SEC after 6 months was achieved in 72/117 patients (61.5%): 44/72 patients with axial PsA (61.5%) and 28/45 patients with axSpA ...

4. nature.com nature.com/articles/s41598-023-50013-7

Assessment of safety profile of secukinumab in real-world ... Secukinumab has elicited a favorable safety profile in clinical trials, but concerns have been raised with higher incidences of inflammatory ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0365059622001209

Evaluation of the efficacy, safety, and side effects of ... Secukinumab has demonstrated high efficacy for the treatment of moderate-to-severe psoriasis and psoriatic arthritis, with a rapid onset of action, sustained ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9631291/

Long-term Safety of Secukinumab Over Five Years in ... Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.

7. ema.europa.eu ema.europa.eu/nl/media/7734

Cosentyx, INN-secukinumab - EMA Missing information: Long-term safety data. Long term safety data. Details. Evidence source. Long-term safety data (> 6 years) continue to be collected in ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/dth/9618241

Long‐Term Real‐World Safety Profile of Secukinumab ... Secukinumab showed sustained safety over an extended 9-year treatment period, supporting its use for the long-term management of these immune- ...

9. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-019-1882-2

Long-term safety of secukinumab in patients with moderate-to ... Secukinumab demonstrated a favorable safety profile over long-term treatment in patients with PsO, PsA, and AS.