Secukinumab Open Label Roll-over Extension Protocol

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

Last Update: Jan 13, 2022

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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 
Phase 4
Overall status 
Recruiting
Start date 
Dec 22, 2020
Completion date 
Sep 30, 2024
Gender 
All
Age(s)
6 Years and older (Child, Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

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.
Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion Criteria:

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).

Study Locations

United States
Novartis Investigative Site
Recruiting
La Mesa, 91942
California
United States
Novartis Investigative Site
Recruiting
Winter Park, 32789
Florida
United States
Novartis Investigative Site
Recruiting
Lincoln, 68516
Nebraska
United States
Novartis Investigative Site
Recruiting
Duncansville, 16635
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Mesquite, 75150
Texas
United States
Brazil
Novartis Investigative Site
Recruiting
Juiz de Fora, 36010 570
MG
Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro, 20241-180
-
Brazil
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1431
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1784
-
Bulgaria
Czech Republic
Novartis Investigative Site
Recruiting
Brno-Zidonice, 61500
CZE
Czech Republic
Novartis Investigative Site
Recruiting
Brno Bohunice, 625 00
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 11, 148 00
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 2, 128 50
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Greece
Novartis Investigative Site
Recruiting
Patra, 26443
-
Greece
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01010
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01011
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala, 01010
-
Guatemala
India
Novartis Investigative Site
Recruiting
Nashik, 422 101
Maharashtra
India
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06351
-
Korea, Republic of
Mexico
Novartis Investigative Site
Recruiting
Metepec, 52140
Estado De Mexico
Mexico
Novartis Investigative Site
Recruiting
Guadalajara, 44160
Jalisco
Mexico
Novartis Investigative Site
Recruiting
Culiacan, 80000
MEX
Mexico
Poland
Novartis Investigative Site
Recruiting
Krakow, 30-510
Malopolskie
Poland
Novartis Investigative Site
Recruiting
Bialystok, 15-351
-
Poland
Novartis Investigative Site
Recruiting
Karwiany, 52-200
-
Poland
Novartis Investigative Site
Recruiting
Krakow, 30 002
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-218
-
Poland
Novartis Investigative Site
Recruiting
Sochaczew, 96-500
-
Poland
Novartis Investigative Site
Recruiting
Torun, 87-100
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 118
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02-962
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 04 305
-
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 53-224
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Barnaul, 656024
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420064
-
Russian Federation
Novartis Investigative Site
Recruiting
Kemerovo, 650000
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115522
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 127473
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
Recruiting
Saratov, 410053
-
Russian Federation
Novartis Investigative Site
Recruiting
Smolensk, 214019
-
Russian Federation
Novartis Investigative Site
Recruiting
Yaroslavl, 150003
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Hospitalet de Llobregat, 08907
Barcelona
Spain
Novartis Investigative Site
Recruiting
Bilbao, 48013
Bizkaia
Spain
Novartis Investigative Site
Recruiting
Santander, 39008
Cantabria
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
Recruiting
Vigo, 36200
Pontevedra
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Novartis Investigative Site
Recruiting
Malaga, 29009
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]