Secukinumab for Psoriatic Arthritis

Recruiting at 1 trial location

Overseen By Novartis Pharmaceuticals

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: Methotrexate, Corticosteroids, NSAIDs

Must not be taking: Non-biologic DMARDs

Disqualifiers: Inflammatory bowel disease, Uveitis, others

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

Compensation: Varies

Number of Visits: 12

Duration: 20 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain medications like methotrexate, oral corticosteroids, and one NSAID, as long as they are on a stable dose for a specified period before the study starts. However, other non-biologic DMARDs are not allowed, except for methotrexate.

Is secukinumab safe for humans?

Secukinumab is generally considered safe for humans, but it can increase the risk of infections, especially in the respiratory tract and with yeast infections. Some people may experience mild to moderate side effects like inflammatory bowel disease or skin reactions, which usually improve after stopping the treatment. ^{1 2 3 4 5}

How does the drug Secukinumab differ from other treatments for psoriatic arthritis?

Secukinumab is unique because it is a fully human monoclonal antibody that specifically targets interleukin-17A, a protein involved in inflammation, making it the first of its kind for treating psoriatic arthritis. It is administered as an injection under the skin and offers an alternative to traditional treatments like tumor necrosis factor inhibitors, with benefits seen even in patients who have not responded to other therapies. ^{6 7 8 9 10}

What data supports the effectiveness of the drug Secukinumab for treating Psoriatic Arthritis?

Research shows that Secukinumab is effective in reducing joint damage and improving symptoms in people with psoriatic arthritis, as seen in multiple studies comparing it to a placebo. It has also been shown to be effective in real-life settings and is well-received by doctors in Europe. ^{11 12 13 14 15}

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 2 to less than 18 with Juvenile Psoriatic Arthritis (JPsA) who haven't responded well to NSAIDs or DMARDs. They should have been diagnosed at least 6 months ago, have active JPsA with ≥3 affected joints, and be on stable doses of certain medications like corticosteroids and methotrexate.

Inclusion Criteria

Participants parent's or legal representative(s) written informed consent and child's assent must be obtained before any study related activity or assessment is performed

I am between 2 and 17 years old.

I was diagnosed with juvenile psoriatic arthritis at least 6 months ago.

Exclusion Criteria

Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer

History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes

I have not taken any medication that is not allowed in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous secukinumab infusions to evaluate pharmacokinetics, safety, and tolerability

20 weeks

Weekly visits for the first 12 weeks, then bi-weekly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

Participants may opt into continuation of treatment long-term up to 6 years

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Secukinumab

Trial Overview The study tests multiple doses of Secukinumab given intravenously to pediatric patients with JPsA. It aims to understand how the drug moves through the body (pharmacokinetics), its safety, and how well young patients tolerate it over a period of up to six years.

How Is the Trial Designed?

Group I: Secukinumab Experimental Treatment 1 Intervention

Secukinumab administered intravenously in pediatric participants with JPsA

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 demonstrated significant efficacy in treating psoriatic arthritis (PsA), showing robust improvements across all core domains, including joint counts, enthesitis, and skin severity, in a pooled analysis of 2049 patients from multiple phase III studies.

At a dosage of 300 mg, secukinumab led to complete resolution of swollen joints in 34.3% of patients and significant improvements in other symptoms, indicating its potential as an effective treatment option for various manifestations of PsA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. Orbai, AM., McInnes, IB., Coates, LC., et al.[2021]

Secukinumab is an effective treatment for psoriasis, psoriatic arthritis, and ankylosing spondylitis, but its long-term safety profile requires further investigation.

While secukinumab is associated with an increased risk of infections, particularly respiratory infections and candidiasis, the evidence for other adverse events remains limited and causal relationships are not fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Safety of Interleukin-17A Inhibitor Secukinumab. Eshwar, V., Kamath, A., Shastry, R., et al.[2022]

Secukinumab, while effective for treating moderate-to-severe psoriasis and psoriatic arthritis, has been associated with a range of adverse events of special interest (AESI) in over 1077 patients, with inflammatory bowel disease being the most common.

Most AESI reported were mild to moderate in severity and typically resolved after discontinuation of secukinumab, suggesting that while the drug is effective, healthcare providers should monitor for these potential side effects to ensure timely management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of secukinumab-induced adverse events of special interest and its potential pathogenesis. Liang, J., Zhang, S., Li, Q., et al.[2022]

In a study involving 1414 patients with psoriatic arthritis (PsA) and 1164 patients with ankylosing spondylitis (AS), secukinumab demonstrated a very low incidence of treatment-emergent antidrug antibodies (TE-ADA), with only 0.35% in PsA and 0.69% in AS patients, indicating good immunogenicity safety.

The presence of TE-ADA did not affect the pharmacokinetics or efficacy of secukinumab, suggesting that the treatment remains effective even in patients who develop these antibodies, and no adverse events were linked to TE-ADA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. Deodhar, A., Gladman, DD., McInnes, IB., et al.[2022]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. [2021]

3. England pubmed.ncbi.nlm.nih.gov

One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Secukinumab in United States Biologic-Naïve Patients With Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled CHOICE Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Real world effectiveness and satisfaction with secukinumab in the treatment of patients with psoriatic arthritis: a population survey in five European countries. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of the Safety of Interleukin-17A Inhibitor Secukinumab. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Review of secukinumab-induced adverse events of special interest and its potential pathogenesis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of secukinumab in psoriasis vulgaris and psoriatic arthritis: Real-world evidence in Japan. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison. [2020]

12. Canada pubmed.ncbi.nlm.nih.gov

Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. [2022]

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

Secukinumab: A Review in Psoriatic Arthritis. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Characteristics of Patients with Psoriatic Arthritis Receiving Secukinumab and Reasons for Initiation: A US Retrospective Medical Chart Review. [2020]

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

Secukinumab: A Review in Psoriatic Arthritis. [2019]