Secukinumab for Polymyalgia Rheumatica

(REPLENISH-EXT Trial)

Recruiting at 78 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Prohibited medications

Disqualifiers: Chronic infections, Malignancy, Live vaccinations, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: 15

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

Will I have to stop taking my current medications?

The trial information mentions the use of prohibited medications, but it does not specify which ones. It's best to discuss your current medications with the trial team to see if any need to be stopped.

What data supports the effectiveness of the drug Secukinumab for treating Polymyalgia Rheumatica?

Secukinumab has been shown to be effective in treating other inflammatory conditions like psoriatic arthritis and ankylosing spondylitis by targeting a protein called interleukin-17A, which plays a role in inflammation. This suggests it might also help with Polymyalgia Rheumatica, which involves inflammation. ^{1 2 3 4 5}

Is secukinumab generally safe for humans?

Secukinumab, also known as Cosentyx, has been studied for conditions like psoriasis, psoriatic arthritis, and rheumatoid arthritis. It is generally well tolerated, with common side effects being mild to moderate infections like upper respiratory tract infections. Longer-term safety data is still limited, but current studies suggest it is safe for use in these conditions. ^{1 3 5 6 7}

How does the drug Secukinumab differ from other treatments for polymyalgia rheumatica?

Secukinumab is unique because it is a fully human monoclonal antibody that targets interleukin-17A, a protein involved in inflammation, and is administered subcutaneously (under the skin). This mechanism of action is different from traditional treatments for inflammatory conditions, which often include corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs). ^{1 2 3 5 8}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for patients with Polymyalgia Rheumatica who completed a previous 52-week secukinumab study and had a relapse. They haven't received rescue treatment, and the doctor believes more benefits than risks are present.

Inclusion Criteria

My condition worsened during the follow-up period after my initial treatment.

I completed a 52-week secukinumab study for PMR.

My doctor thinks secukinumab could help me more than harm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment Period 1

Participants receive secukinumab from Baseline to Week 24 with visits every 4 weeks

24 weeks

6 visits (in-person), optional visits at Weeks 16 and 20

Treatment Period 2

Participants continue receiving secukinumab up to 2 years with visits every 12 weeks

up to 2 years

8 visits (in-person) every 12 weeks, with option for more frequent visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

1 visit (in-person) 20 weeks after last dose

Treatment Details

Interventions

• Secukinumab

Trial Overview The trial tests the long-term safety of Secukinumab in treating Polymyalgia Rheumatica. It's an open-label extension study, meaning everyone knows they're getting Secukinumab and it's given over an extended period.

Participant Groups

Group I: Secukinumab 300mg Experimental Treatment 1 Intervention

All eligible participants will receive secukinumab 300 mg s.c. (2 x 150mg/1mL PFS secukinumab) from baseline and every 4 weeks up to 2 years. The study medication may be modified/adjusted after the initial doses of 300mg s.c. (decreased to 150mg s.c. q4w or increased again from 150mg s.c. q4w to 300mg s.c. q4w) if deemed appropriate by the investigator. Dose modification/adjustment may only occur from Week 24 visit onwards. The modification/adjustment of the study medication will be determined at a site visit.

Secukinumab is already approved in European Union, United States for the following indications:

Approved in European Union as Cosentyx for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Ankylosing spondylitis
• Non-radiographic axial spondyloarthritis

Approved in United States as Cosentyx for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Ankylosing spondylitis
• Non-radiographic axial spondyloarthritis
• Hidradenitis suppurativa

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, 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, 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 a newly approved interleukin-17 (IL-17) inhibitor that effectively targets and blocks the proinflammatory cytokine IL-17A, which is involved in autoimmune diseases like rheumatoid arthritis and psoriatic arthritis.

This biologic treatment has shown promise in reducing inflammation and disease progression in moderate-to-severe cases of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, marking a significant advancement in the management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab for rheumatology: development and its potential place in therapy. Koenders, MI., van den Berg, WB.[2019]

Secukinumab (Cosentyx™) is a fully human monoclonal antibody that targets interleukin-17A, approved for treating psoriasis and psoriatic arthritis in adults who do not respond adequately to other systemic therapies.

It received its first global approval in Japan in December 2014 and was subsequently approved in the USA and EU in early 2015, with ongoing investigations for additional conditions like ankylosing spondylitis and rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: first global approval. Sanford, M., McKeage, K.[2019]

Secukinumab 150 mg demonstrated significantly better clinical efficacy in treating active rheumatoid arthritis (RA) patients who did not respond adequately to TNF inhibitors, with notable improvements in ACR20, ACR50, and ACR70 response rates over 24 weeks.

There was no increased risk of adverse effects or serious adverse effects associated with secukinumab compared to placebo, indicating it is a safe therapeutic option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Huang, Y., Fan, Y., Liu, Y., et al.[2020]

In a phase III study involving patients with rheumatoid arthritis who did not respond to TNF-α inhibitors, secukinumab did not show statistically significant improvements in ACR20 response rates compared to placebo at week 24.

The study confirmed the safety of secukinumab, with no new adverse events reported, but suggested that it may not offer additional benefits over existing second-line therapies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab after anti-tumour necrosis factor-α therapy: a phase III study in active rheumatoid arthritis. Dokoupilová, E., Aelion, J., Takeuchi, T., et al.[2019]

Secukinumab, a biologic treatment approved for psoriatic arthritis (PsA) in 2016, shows promising safety and efficacy based on clinical trial evidence, indicating it may be as effective as other treatment options.

Further direct comparison studies are needed to better understand secukinumab's role in treatment guidelines for PsA, as current evidence suggests it is a viable option among existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Use of Secukinumab for Psoriatic Arthritis. Patel, NU., Vera, NC., Shealy, ER., et al.[2021]

References

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

Secukinumab: A Review in Psoriatic Arthritis. [2021]

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

Secukinumab: A Review in Ankylosing Spondylitis. [2019]

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

Secukinumab: A Review in Psoriatic Arthritis. [2019]

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

Secukinumab for rheumatology: development and its potential place in therapy. [2019]

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

Secukinumab: first global approval. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Secukinumab after anti-tumour necrosis factor-α therapy: a phase III study in active rheumatoid arthritis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A Review of the Use of Secukinumab for Psoriatic Arthritis. [2021]