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Secukinumab Open Label Roll-over Extension Protocol

Primary Purpose

Autoimmunity, Inflammation

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Secukinumab s.c. injection
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmunity, Inflammation focused on measuring Secukinumab, Post trial access

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Novartis Investigative SiteRecruiting
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  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab s.c.

Arm Description

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.

Outcomes

Primary Outcome Measures

To evaluate long term safety as assessed by occurrence of AEs/SAEs
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
October 3, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04638647
Brief Title
Secukinumab Open Label Roll-over Extension Protocol
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
October 30, 2026 (Anticipated)
Study Completion Date
January 5, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmunity, Inflammation
Keywords
Secukinumab, Post trial access

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
715 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab s.c.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Secukinumab s.c. injection
Intervention Description
Secukinumab pre-filled syringes (PFS) for s.c. injection
Primary Outcome Measure Information:
Title
To evaluate long term safety as assessed by occurrence of AEs/SAEs
Description
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40150 150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vitoria
State/Province
ES
ZIP/Postal Code
29055 450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010 570
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266 010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01244-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090 000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guang Zhou
State/Province
Guang Dong Province
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10050
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bengbu
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhejiang
ZIP/Postal Code
315016
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
0001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ibague
State/Province
Tolima
ZIP/Postal Code
730006
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cundinamarca
ZIP/Postal Code
111121
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ostrava
State/Province
Czech Republic
ZIP/Postal Code
772 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brno-Zidonice
State/Province
CZE
ZIP/Postal Code
61500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Prague
State/Province
Prague 1
ZIP/Postal Code
11000
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Brno Bohunice
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Prague 4
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 11
ZIP/Postal Code
14900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Patra
ZIP/Postal Code
26443
Country
Greece
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01011
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01009
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395009
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 079
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 053
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Metepec
State/Province
Estado De Mexico
ZIP/Postal Code
52140
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Culiacan
State/Province
MEX
ZIP/Postal Code
80000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
30 002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 118
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 637
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
04 305
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
53-224
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620023
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119296
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Secukinumab Open Label Roll-over Extension Protocol

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