Secukinumab Open Label Roll-over Extension Protocol

Last Update: Aug 12, 2024

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

ClinicalTrials.gov Identifier:

NCT04638647

Novartis Reference Number:CAIN457A02001B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Phase

Phase4

Overall Status

Recruiting

Number of Participants

715

Start Date

Dec 22, 2020

Completion Date

Feb 29, 2028

Gender

All

Age(s)

6 Years - (Child, Adult, Older Adult)

Interventions

Biological

Secukinumab s.c. injection

Secukinumab pre-filled syringes (PFS) for s.c. injection

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 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).