Last Update: Aug 18, 2026 An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment ClinicalTrials.gov Identifier: [NCT04638647](https://clinicaltrials.gov/ct2/show/NCT04638647) Novartis Reference Number:CAIN457A02001B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation. Condition Autoimmunity, Inflammation Phase Phase4 Overall Status Recruiting Number of Participants1000 Start Date Dec 22, 2020 Completion Date Apr 04, 2030 Gender All Age(s) 6 Years - 100 Years (Child, Adult, Older Adult) ## Interventions Biological ### Secukinumab s.c. injection Secukinumab pre-filled syringes (PFS) for s.c. injection ## Eligibility Criteria 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). Czechia #### Novartis Investigative Site Recruiting Brno-Zidonice,CZE,61500,Czechia #### Novartis Investigative Site Recruiting Prague,148 00,Czechia #### Novartis Investigative Site Recruiting Prague,128 00,Czechia #### Novartis Investigative Site Recruiting Brno,625 00,Czechia #### Novartis Investigative Site Recruiting Uherské Hradiště,686 01,Czechia #### Novartis Investigative Site Recruiting Prague,150 06,Czechia #### Novartis Investigative Site Recruiting Prague,140 59,Czechia #### Novartis Investigative Site Recruiting Ostrava,Czech Republic,772 00,Czechia Japan #### Novartis Investigative Site Recruiting Ōme,Tokyo,198-0042,Japan Poland #### Novartis Investigative Site Recruiting Torun,87-100,Poland #### Novartis Investigative Site Recruiting Krakow,30-002,Poland #### Novartis Investigative Site Recruiting Bydgoszcz,85-168,Poland Spain #### Novartis Investigative Site Recruiting Madrid,28009,Spain #### Novartis Investigative Site Recruiting Madrid,28046,Spain United States #### Rheumatology Associates of South Florida Recruiting Boca Raton,Florida,33486,United States ###### Shawn Baca ###### Heather Gliatta Phone: [+1 561 361 6547]() Email: #### FL Medical Clinic Orlando Health Recruiting Zephyrhills,Florida,33542,United States ###### William Daily Johnston Phone: [+1 813 782 1234]() Email: ###### Natalie Faith ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: