Long-term treatment with secukinumab for patients who completed a previous trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the long-term safety of secukinumab in participants who have previously completed a Novartis trial and are deemed by their investigator to benefit from continued treatment. Participants who cannot access the marketed formulation of secukinumab will receive subcutaneous injections of the medication. The study focuses on individuals with autoimmune and inflammatory conditions, ensuring they have provided informed consent before participation. The goal is to provide ongoing treatment for those who have shown positive responses in earlier trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons).
4. Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion Criteria:

1. Participant has prematurely discontinued study treatment in the parent protocol.
2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).

Where it's running

• Rheumatology Associates of South Florida
  Boca Raton, Florida, United States Recruiting
• FL Medical Clinic Orlando Health
  Zephyrhills, Florida, United States Recruiting
• Novartis Investigative Site
  Genk, Belgium, Belgium Recruiting
• Novartis Investigative Site
  Ostrava, Czech Republic, Czechia Recruiting
• Novartis Investigative Site
  Brno-Zidonice, Cze, Czechia Recruiting
• Novartis Investigative Site
  Brno, Czechia Recruiting

+123 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.