Table of Contents

• Trial overview
• Conditions studied in Secukinumab trials
• How the trials are designed
• Main outcomes and endpoints
• Who can participate
• Important features patients may see in these studies
• Safety follow-up and long-term studies

Trial overview

The trial data show that Secukinumab is being studied in many different inflammatory diseases, not just one condition.^[1] Most of the studies are Phase 3 trials, which are larger studies that usually compare treatment groups and measure how well a treatment works in real patient groups.^[1] There is also a Phase 2 study in patients with a severe and resistant inflammatory disease, which is an earlier stage of testing.^[4]

Several trials are already completed, while others are authorised and ongoing or ready to start.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

Conditions studied in Secukinumab trials

The studies include a wide range of conditions. These include polymyalgia rheumatica, which causes pain and stiffness; giant cell arteritis, a blood vessel inflammation disease; and Takayasu arteritis, another large-vessel inflammatory disease.^{[1][2][9][10][11]}

Other trials study psoriatic arthritis, psoriasis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, rotator cuff tendinopathy, and chronic rhinosinusitis with nasal polyps.^{[3][5][6][7][8][12][13][14]}

One study looks at patients with a non-classified, severe and resistant inflammatory disease, meaning a serious inflammatory illness that does not fit into one standard diagnosis and has not responded well to prior treatment.^[4] Another study includes children with juvenile idiopathic arthritis, which is arthritis that begins in childhood.^[15]

How the trials are designed

Several studies compare Secukinumab with placebo, which is a look-alike treatment with no active study drug.^{[2][5][6][8][10][11][13]}

Some trials use an open-label design, which means both the study team and participants know what treatment is being given.^{[1][14] Other studies are double-blind, which means neither the participant nor the study team knows who gets which treatment during the blinded part of the study.[7]}

A few studies are withdrawal-retreatment or extension studies, which means people who first improved may later switch treatment or continue follow-up so researchers can see how long the response lasts.^{[5][6] One psoriasis study also compares Secukinumab with another product, CT-P55, to see if the two treatments are equivalent in effect.[7]}

Main outcomes and endpoints

The main outcome in many trials is related to remission, relapse, or flare. For example, the giant cell arteritis studies measure time to first clinical relapse or sustained remission at week 52.^[2][10]

Other studies measure symptom scores. In psoriasis, the main endpoint may be change in the PASI score, which is a standard way to measure how severe psoriasis is.^[7] In rotator cuff tendinopathy, the trials use the WORC physical symptom domain score, which measures shoulder-related physical problems.^[3][12]

In hidradenitis suppurativa, the main measure is HiSCR response and time to loss of response, which looks at whether the number of abscesses and inflammatory nodules improves and stays improved.^[6] In chronic rhinosinusitis with nasal polyps, the study measures changes in NPS and SNOT-22 scores, which track nasal polyp burden and sinus-related quality of life.^[14]

Some studies use broader inflammatory or disease activity measures, such as PASDAS in psoriatic arthritis or NIH disease activity criteria in Takayasu arteritis.^{[3][11] The safety-focused studies mainly record adverse events, serious adverse events, and injection site reactions.[1][13]}

Who can participate

Eligibility depends on the trial and the disease being studied.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}

Some trials include people with active disease, such as newly diagnosed giant cell arteritis, moderate-to-severe psoriasis, or moderate-to-severe hidradenitis suppurativa.^{[2][5][6][7][8]}

Other studies include people who are already in clinical remission, meaning their disease is currently quiet, and the study asks whether treatment can keep it under control or prevent flares.^{[5][6] The juvenile idiopathic arthritis study focuses on children who have reached clinical inactive disease and do not have subclinical inflammation, which means hidden inflammation seen on imaging or other tests.[15]}

Important features patients may see in these studies

Several trials use a glucocorticoid taper regimen, which is a planned step-by-step lowering of steroid treatment over time.^{[2][10][11][12]}

In polymyalgia rheumatica and giant cell arteritis, Secukinumab is studied together with a steroid taper plan to see whether it can improve sustained remission compared with placebo plus steroid tapering.^{[2][10] In psoriatic arthritis, one study is not testing Secukinumab as a new treatment, but rather includes it among several biologics while researchers look at how far treatment can be reduced without symptoms coming back.[3]}

The HELIOS psoriasis study asks whether proactive TDM, meaning proactive therapeutic drug monitoring, is non-inferior to standard care for keeping disease controlled over 18 months.^[5] In this setting, the goal is to see whether planned monitoring and treatment adjustment works at least as well as usual care.^[5]

Safety follow-up and long-term studies

Some of the most important Secukinumab studies are designed to learn about long-term safety.^{[1][13] These studies follow people over time and record adverse events, serious adverse events, and sometimes injection site reactions.[1][13]}

The extension study in polymyalgia rheumatica is specifically looking at long-term safety and tolerability in a larger group of participants.^[1] Another open-label study includes people who completed earlier Novartis-sponsored Secukinumab studies and are judged by the investigator to benefit from continued treatment.^[13]

These follow-up studies are important because they help show what happens when treatment continues beyond the first trial period.^{[1][13] They also help researchers understand safety in broader groups, including people with different immune-mediated diseases.[13]}

Selected trial details

The table below gives a short view of the main studies in the data.^{[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]}