Secukinumab for Psoriatic Arthritis

Recruiting at 4 trial locations

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?

This trial tests secukinumab, administered through an IV, for children with juvenile psoriatic arthritis (JPsA). The goal is to understand how the body processes the drug and to assess its safety and tolerability. Children who have had JPsA for at least 6 months, with at least 3 swollen or tender joints, and who haven't responded to treatments like NSAIDs or DMARDs, may be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that secukinumab is well-tolerated by patients with psoriatic arthritis. One study found it safe over five years, with patients experiencing ongoing symptom relief. Another study demonstrated a good safety record for patients using secukinumab, allowing them to continue treatment for four years without major side effects that would necessitate stopping.

Although these studies focused on adults, they offer some reassurance about the treatment's safety. However, this trial is in an early stage, and more research is needed to fully understand how secukinumab works in children with juvenile psoriatic arthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for psoriatic arthritis, which often include TNF inhibitors and methotrexate, Secukinumab targets a different pathway by inhibiting interleukin-17A (IL-17A), a protein involved in inflammatory responses. This unique mechanism of action can potentially offer relief to patients who do not respond well to existing therapies. Additionally, Secukinumab is administered intravenously in this trial, which may enhance its effectiveness and provide a new option for pediatric patients with juvenile psoriatic arthritis (JPsA). Researchers are excited about its potential to offer a more targeted and efficient treatment for this challenging condition.

What evidence suggests that secukinumab might be an effective treatment for JPsA?

Research has shown that secukinumab effectively treats psoriatic arthritis. Studies have found it reduces symptoms and pain in key areas for patients. Those using secukinumab report overall improvement. One study found secukinumab effective and safe for four years, with many patients continuing treatment. Another study noted lasting symptom improvement for up to five years. These findings suggest secukinumab could be a promising option for managing psoriatic arthritis. ^{2 6 7 8 9}

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10694458/

Real-world effectiveness and persistence of secukinumab in ... Secukinumab showed long-term effectiveness across the six key PsA domains thus reducing disease activity and pain, which are major treatment ...

2. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-024-03401-x

Four-year effectiveness, safety and drug retention rate of ... Secukinumab proved safe and effective, and patients achieved sustained remission with a notable drug retention rate at 4 years.

3. jrheum.org jrheum.org/content/49/7/700

Effectiveness of 6-month Use of Secukinumab in Patients ... Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X24001350

Four-year secukinumab treatment outcomes in European ... This large European real-world study demonstrates that 4-year secukinumab retention rates were approximately 50% in both axSpA and PsA.

5. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30036-9/abstract

Long-term efficacy and safety of secukinumab in patients ... Secukinumab 300 mg and 150 mg provided sustained improvement in the signs and symptoms of psoriatic arthritis, with consistent safety over 5 years. This study ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38625671/

Efficacy and Safety of Secukinumab in US Patients with ... Conclusions: In this challenging sub-population of US patients with PsA, secukinumab provided rapid improvements in disease activity and QoL.

7. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30036-9/fulltext

Long-term efficacy and safety of secukinumab in patients ... Secukinumab 300 mg and 150 mg provided sustained improvement in the signs and symptoms of psoriatic arthritis, with consistent safety over 5 years. This study ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03031782

Study Details | NCT03031782 | Secukinumab Safety and ... This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6702584/

Efficacy and Safety of Subcutaneous Secukinumab 150 mg ... The secukinumab 150 mg or 150 mg no-load regimen demonstrated significant and sustained improvements in the signs and symptoms of psoriatic arthritis through ...