Secukinumab Open Label Roll-over Extension Protocol

  • End date
    Jan 5, 2027
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 4 October 2022


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
Treatment Secukinumab s.c. injection
Clinical Study IdentifierNCT04638647
SponsorNovartis Pharmaceuticals
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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