Secukinumab Open Label Roll-over Extension Protocol
ConditionAutoimmunity, Inflammation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Secukinumab s.c. injection
Biological/VaccineSecukinumab pre-filled syringes (PFS) for s.c. injection
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Secukinumab s.c.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate long term safety as assessed by occurrence of AEs/SAEs
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov