Secukinumab Open Label Roll-over Extension Protocol
Recruiting
Phase 4Interventional Study
Autoimmunity, Inflammation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 100
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults and children who have benefited from a prior secukinumab treatment and cannot access the medication commercially. Participants will continue receiving secukinumab under close medical supervision.
Are You a Good Fit for This Trial?
You may be able to join if
I have given my consent to participate.
I can communicate effectively with the study staff.
I have completed a Novartis secukinumab study.
I am benefiting from secukinumab as assessed by the study doctor.
I cannot obtain the marketed secukinumab.
You may not be able to join if
I stopped my treatment early in the previous study.
I can become pregnant and am not using contraception.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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…
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).
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