Secukinumab Open Label Roll-over Extension Protocol
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
Novartis Pharmaceuticals
1,000 participants
Dec 22, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria2
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Secukinumab pre-filled syringes (PFS) for s.c. injection
Locations(167)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04638647