Secukinumab Open Label Roll-over Extension Protocol

Recruiting now · Phase 4

Conditions studied: Autoimmunity, Inflammation

In brief

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.

Key facts

Study ID

NCT04638647

Run by

Novartis Pharmaceuticals

People needed

1000

Starts

2020-12-22

Expected to finish

2030-04-04

Last updated by the study team

2026-07-08

Who can join

Age: 6 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
• 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).
• 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.
• Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

You may not qualify if…

• Participant has prematurely discontinued study treatment in the parent protocol.
• 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 is running

• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Brno, Czechia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Saint Petersburg, Russia (enrolling)
• Novartis Investigative Site — Krakow, Poland (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Brno, Czechia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Uherské Hradiště, Czechia (enrolling)
• Novartis Investigative Site — Torun, Poland (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• FL Medical Clinic Orlando Health — Zephyrhills, Florida, United States (enrolling)
• Novartis Investigative Site — Bydgoszcz, Poland (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Ostrava, Czech Republic, Czechia (enrolling)
• Novartis Investigative Site — Brno-Zidonice, CZE, Czechia (enrolling)
• Rheumatology Associates of South Florida — Boca Raton, Florida, United States (enrolling)
• Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana, United States
• Willow Rheumatology Wellness — Willowbrook, Illinois, United States
• Center for Rheumatology Research — West Hills, California, United States
• Austin Regional Clinic Rheumatology — Austin, Texas, United States
• Conquest Research — Winter Park, Florida, United States
• Medvin Clinical Research — Van Nuys, California, United States
• Accurate Clinical Research Inc — Houston, Texas, United States
• Precn Comprehensive Clnl Rsch Solns — San Leandro, California, United States

Full record on ClinicalTrials.gov

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