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Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a treatment called Secukinumab, which is used for several conditions, including Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, and Juvenile Idiopathic Arthritis. Secukinumab is administered as a solution for injection, and the study aims to evaluate its safety over a long period by monitoring any adverse events or reactions at the injection site.

The purpose of this study is to assess the long-term safety of Secukinumab in patients who have previously participated in a related study and are believed to benefit from continued treatment. Participants will receive Secukinumab through subcutaneous injections, which means the medication is injected under the skin. The study will continue for a period of up to 104 weeks, during which the safety of the treatment will be closely monitored by healthcare professionals.

Throughout the study, participants will be observed for any serious adverse events (SAEs) or adverse events (AEs), which are any unwanted effects that may occur during treatment. The study is open-label, meaning both the participants and the researchers know which treatment is being administered. This trial is designed to ensure that patients who benefit from Secukinumab can continue to receive it safely, with careful monitoring to manage any potential risks.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and baseline assessment

    The patient attends the first clinic visit after joining the study. during this visit, baseline health information is recorded and a physical examination is performed. the purpose is to document the condition before treatment continues.

    The investigator confirms that the patient is eligible to receive continued treatment with secukinumab.

  2. Step 2

    First dose of secukinumab

    The patient receives a single 300 mg dose of secukinumab administered by subcutaneous injection (injection under the skin). the injection is given by a healthcare professional in the clinic.

  3. Step 3

    Regular dosing visits

    Subsequent clinic visits are scheduled according to the investigator’s plan. at each visit, the patient receives another 300 mg dose of secukinumab by subcutaneous injection.

    The interval between injections follows the study protocol and continues for the duration of the trial, which may extend up to the projected end date of 2027-01-05.

  4. Step 4

    Safety monitoring and reporting

    At every visit, the patient is asked about any new symptoms, including adverse events (any unwanted medical occurrences) and serious adverse events (events that require medical attention or hospitalization).

    The investigator records any injection site reactions, such as redness or swelling at the injection location.

  5. Step 5

    Ongoing assessments

    Periodic assessments may include laboratory tests and physical examinations to evaluate long‑term safety of the medication.

    The patient’s medical records are updated with the results of each assessment.

  6. Step 6

    Final visit and study completion

    The last scheduled visit occurs when the study reaches its planned end date or when the investigator determines that continued treatment is no longer appropriate.

    During the final visit, a comprehensive safety evaluation is performed and the patient’s participation in the trial is formally concluded.

Who can join the trial?

6 criteria

  • Provide a signed informed consent (for adults) or, if you are a child, give written assent plus permission from a parent or guardian before any study procedures begin; you must sign the consent again if you become an adult during the study.
  • Be able to talk with the study doctor, understand the study instructions, and be willing to follow the study rules.
  • Have already finished a previous Novartis study that used the medicine secukinumab (a drug used to treat certain joint and skin conditions), unless that earlier study was stopped for reasons not related to safety or lack of effect.
  • Be currently receiving benefit from secukinumab, and the doctor must think you will continue to benefit more than any possible risk.
  • Be unable to obtain the regular market version of secukinumab through your local prescription or insurance plans.
  • Be of any gender (male or female) and fall within the age ranges allowed by the study, which include children and adults as defined by local law.

Who cannot join the trial?

8 criteria

  • If you have already stopped the study medication early in a previous related trial (prematurely discontinued the treatment), you cannot join this study.
  • If you are taking any medicines that are on the study’s “not allowed” list (prohibited medications), you cannot join this study.
  • Women who could become pregnant (childbearing potential) must use an approved birth‑control method for the entire study; otherwise they cannot join. Acceptable methods include:
    • Total abstinence only if it matches the woman’s normal lifestyle.
    • Surgical sterilization (removal of ovaries, removal of uterus, or tying of fallopian tubes) performed at least six weeks before starting the study.
    • A male partner who has had a vasectomy (surgical sterilization) at least six months before the study, and who is the only sexual partner.
    • Barrier methods such as condoms (or a diaphragm) – in the United Kingdom a condom must be used with spermicide.
    • Hormonal birth‑control methods that are over 99 % effective, such as birth‑control pills, patches, rings, implants, or an intrauterine device (IUD) or intrauterine system (IUS), provided the woman has been using the same method for at least three months.
    • Women who are naturally without periods for 12 months (post‑menopausal) or who have had the necessary surgeries listed above are considered not to have childbearing potential and may join.
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Investigated drugs

Secukinumab is a medication given as an injection under the skin. It belongs to a class of medicines called biologics, which are made from living cells. Secukinumab works by blocking a protein in the body that can cause inflammation and damage to the skin, joints, and other parts of the body. In this trial, patients who have already taken secukinumab in a previous study continue receiving the medicine so researchers can watch how safe it is when used for a longer time. The study looks for any side effects or serious problems that might happen while the patients keep using the drug.

What is already known about the treatment

Secukinumab - It is given as a subcutaneous injection, usually a 300 mg dose placed under the skin. Secukinumab is an approved and well‑studied drug used for several inflammatory joint and skin conditions. It works by attaching to the protein interleukin‑17A and blocking its role in causing inflammation. The medication belongs to the class of biologic monoclonal antibodies that target the immune system.

Investigated diseases

  • Psoriatic Arthritis

    a type of arthritis that occurs in people with psoriasis, causing joint pain, swelling, and stiffness; it can affect the fingers, toes, and spine, and may lead to progressive joint changes over time.

  • Ankylosing Spondylitis

    a long‑term inflammation of the spine and sacroiliac joints that causes back pain and stiffness; with time the vertebrae can become fused, reducing flexibility of the spine.

  • Non‑radiographic Axial Spondyloarthritis

    an early form of axial spondyloarthritis where inflammation causes back pain and stiffness but does not yet show on X‑ray; it may later develop visible changes in the spine.

  • Severe Chronic Plaque Psoriasis

    a skin condition marked by thick, red, scaly patches that cover large areas of the body; the plaques can become increasingly thick and cause itching or discomfort.

  • Moderate to severe Chronic Plaque Psoriasis

    a skin disorder with red, scaly plaques affecting a moderate to large part of the body; the lesions may expand and become more noticeable over time.

  • Juvenile idiopathic arthritis

    a group of arthritis conditions that start before age 16, causing joint swelling, pain, and limited movement; it can involve one or many joints and may persist as the child grows.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504417-67-00Protocol codeCAIN457A02001BEstimated enrolment838 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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