Recruiting

Secukinumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT04638647

Conditions

Autoimmunity, Inflammation

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

Interventions

Secukinumab s.c. injection

Study Details

Brief 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.

Conditions

Autoimmunity, Inflammation

Study ID

NCT04638647

Start date

Dec 22, 2020

Status verified date

Aug, 2026

Completion date

Apr 4, 2030

Anticipated

Primary completion date

Jan 29, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Secukinumab s.c.

Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.

Interventions

Secukinumab s.c. injection

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

Primary outcome measure

  • To evaluate long term safety as assessed by occurrence of AEs/SAEs [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

Rheumatology Associates of South Florida

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Principal Investigator:

Shawn Baca

FL Medical Clinic Orlando Health

Recruiting

Zephyrhills, Florida, United States, 33542

Contacts

Principal Investigator:

Natalie Faith

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Secukinumab, Post trial access

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.