Long-Term Safety of Secukinumab for Autoimmune Inflammation

Recruiting at 117 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

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

Research Team

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.

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

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

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.

Participant Groups

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

Findings from Research

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]

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, 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]

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, 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Ankylosing Spondylitis. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature. [2019]

6. Canada 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. [2019]