Last Update: Dec 22, 2025
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:
Novartis Reference Number:CAIN457A02001B
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.

Autoimmunity, Inflammation
Phase4
Recruiting
1000
Dec 22, 2020
Apr 04, 2030
All
6 Years - 100 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).

Novartis Investigative Site

Recruiting

Ningbo,Zhejiang,315016,China

Novartis Investigative Site

Recruiting

Ürümqi,Xinjiang,830001,China

Novartis Investigative Site

Recruiting

Hefei,Anhui,230601,China

Novartis Investigative Site

Recruiting

Wuhan,Hubei,430030,China

Novartis Investigative Site

Recruiting

Yangzhou,Jiangsu,225001,China

Novartis Investigative Site

Recruiting

Chengdu,Sichuan,610041,China

Novartis Investigative Site

Recruiting

Wenzhou,Zhejiang,325000,China

Novartis Investigative Site

Recruiting

Beijing,100000,China

Novartis Investigative Site

Recruiting

Shanghai,200040,China

Novartis Investigative Site

Recruiting

Kunming,Yunnan,650000,China

Novartis Investigative Site

Recruiting

Bucaramanga,Santander Department,680003,Colombia

Novartis Investigative Site

Recruiting

Prague,150 06,Czechia

Novartis Investigative Site

Recruiting

Brno,625 00,Czechia

Novartis Investigative Site

Recruiting

Uherské Hradiště,686 01,Czechia

Novartis Investigative Site

Recruiting

Brno-Zidonice,CZE,61500,Czechia

Novartis Investigative Site

Recruiting

Ostrava,Czech Republic,772 00,Czechia

Novartis Investigative Site

Recruiting

Prague,128 00,Czechia

Novartis Investigative Site

Recruiting

Prague,148 00,Czechia

Novartis Investigative Site

Recruiting

Prague,140 59,Czechia

Novartis Investigative Site

Recruiting

Guatemala City,01001,Guatemala

Novartis Investigative Site

Recruiting

Guatemala City,01009,Guatemala

Novartis Investigative Site

Recruiting

Bialystok,15-351,Poland

Novartis Investigative Site

Recruiting

Torun,87-100,Poland

Novartis Investigative Site

Recruiting

Krakow,30-002,Poland

Novartis Investigative Site

Recruiting

Bydgoszcz,85-168,Poland

Novartis Investigative Site

Recruiting

Saint Petersburg,197198,Russia

Novartis Investigative Site

Recruiting

Madrid,28046,Spain

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Overlake Arthritis and Osteoporosis

Recruiting

Bellevue,Washington,98004,United States

Arinola Dada
Varsha Sridhar

Accurate Clinical Research Inc

Recruiting

San Antonio,Texas,78229,United States

Philip Waller
Yanet Martinez

Rheumatology Associates of South Florida

Recruiting

Boca Raton,Florida,33486,United States

Shawn Baca
Heather Gliatta

Oregon Health Sciences University

Recruiting

Portland,Oregon,97239,United States

Atul Deodhar
Kim Phung Karimzadeh

Altoona Center for Clin Res

Recruiting

Duncansville,Pennsylvania,16635,United States

Pam Morrison
Alan J Kivitz

FL Medical Clinic Orlando Health

Recruiting

Zephyrhills,Florida,33542,United States

William Daily Johnston
Natalie Faith

Rheumatology Pulmonary Clinic

Recruiting

Beckley,West Virginia,25801,United States

Wassim S Saikali
Tammy McManus

West Tennessee Research Institute

Recruiting

Jackson,Tennessee,38305,United States

Trina Lawrence
Jacob A Aelion

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