Secukinumab Open Label Roll-over Extension Protocol

August 17, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Completed
        • Novartis Investigative Site
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Completed
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Completed
        • Novartis Investigative Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Completed
        • Novartis Investigative Site
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090 000
        • Completed
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01244-030
        • Completed
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04266-010
        • Completed
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Active, not recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Completed
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1784
        • Completed
        • Novartis Investigative Site
    • Bulgaria
      • Plovdiv, Bulgaria, Bulgaria, 4002
        • Completed
        • Novartis Investigative Site
      • Sofia, Bulgaria, Bulgaria, 1407
        • Active, not recruiting
        • Novartis Investigative Site
      • Stara Zagora, Bulgaria, Bulgaria, 6000
        • Active, not recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100050
        • Completed
        • Novartis Investigative Site
      • Beijing, China, 100000
        • Active, not recruiting
        • Novartis Investigative Site
      • Beijing, China, 100730
        • Completed
        • Novartis Investigative Site
      • Bengbu, China, 233004
        • Active, not recruiting
        • Novartis Investigative Site
      • Jinan, China, 250012
        • Completed
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200127
        • Completed
        • Novartis Investigative Site
      • Shanghai, China, 200050
        • Active, not recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Active, not recruiting
        • Novartis Investigative Site
    • Anhui
      • Hefei, Anhui, China, 230001
        • Active, not recruiting
        • Novartis Investigative Site
      • Hefei, Anhui, China, 230601
        • Active, not recruiting
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Active, not recruiting
        • Novartis Investigative Site
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Completed
        • Novartis Investigative Site
    • Fujian
      • Xiamen, Fujian, China, 361001
        • Active, not recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Active, not recruiting
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510080
        • Completed
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510120
        • Completed
        • Novartis Investigative Site
      • Shantou, Guangdong, China, 515000
        • Active, not recruiting
        • Novartis Investigative Site
      • Shenzhen, Guangdong, China, 518020
        • Active, not recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Active, not recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Active, not recruiting
        • Novartis Investigative Site
      • Zhuzhou, Hunan, China, 412000
        • Completed
        • Novartis Investigative Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Active, not recruiting
        • Novartis Investigative Site
      • Hohhot, Inner Mongolia, China, 010050
        • Completed
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Active, not recruiting
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210009
        • Active, not recruiting
        • Novartis Investigative Site
      • Yangzhou, Jiangsu, China, 225001
        • Active, not recruiting
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Completed
        • Novartis Investigative Site
      • Pingxiang, Jiangxi, China, 337000
        • Active, not recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Active, not recruiting
        • Novartis Investigative Site
    • Shandong
      • Linyi, Shandong, China, 276000
        • Active, not recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Completed
        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Active, not recruiting
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Active, not recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Ningbo, Zhejiang, China, 315016
        • Active, not recruiting
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • Novartis Investigative Site
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Completed
        • Novartis Investigative Site
      • Chía, Cundinamarca, Colombia, 250001
        • Completed
        • Novartis Investigative Site
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680003
        • Completed
        • Novartis Investigative Site
    • Tolima Department
      • Ibague, Tolima Department, Colombia, 730006
        • Completed
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Novartis Investigative Site
      • Hradec Králové, Czechia, 500 05
        • Active, not recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 148 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 140 59
        • Recruiting
        • Novartis Investigative Site
      • Uherské Hradiště, Czechia, 686 01
        • Recruiting
        • Novartis Investigative Site
    • CZE
      • Brno-Zidonice, CZE, Czechia, 61500
        • Recruiting
        • Novartis Investigative Site
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 772 00
        • Recruiting
        • Novartis Investigative Site
    • Prague 1
      • Prague, Prague 1, Czechia, 11000
        • Active, not recruiting
        • Novartis Investigative Site
  • Greece
    • Greece
      • Pátrai, Greece, Greece, 26443
        • Withdrawn
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Completed
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01001
        • Completed
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01009
        • Completed
        • Novartis Investigative Site
    • Departamento de Guatemala
      • Guatemala City, Departamento de Guatemala, Guatemala, 01010
        • Completed
        • Novartis Investigative Site
      • Guatemala City, Departamento de Guatemala, Guatemala, 01011
        • Completed
        • Novartis Investigative Site
  • India
    • Gujarat
      • Surat, Gujarat, India, 395009
        • Completed
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 079
        • Completed
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Completed
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422101
        • Completed
        • Novartis Investigative Site
    • New Delhi
      • New Delhi, New Delhi, India, 110029
        • Completed
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Completed
        • Novartis Investigative Site
  • Italy
    • FI
      • Florence, FI, Italy, 50134
        • Completed
        • Novartis Investigative Site
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Completed
        • Novartis Investigative Site
  • Japan
    • Tokyo
      • Ōme, Tokyo, Japan, 198-0042
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Completed
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Completed
        • Novartis Investigative Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Completed
        • Novartis Investigative Site
    • State of Mexico
      • Culiacan, State of Mexico, Mexico, 80000
        • Completed
        • Novartis Investigative Site
      • Metepec, State of Mexico, Mexico, 52140
        • Completed
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-351
        • Completed
        • Novartis Investigative Site
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Novartis Investigative Site
      • Krakow, Poland, 30-002
        • Recruiting
        • Novartis Investigative Site
      • Poznan, Poland, 60-218
        • Completed
        • Novartis Investigative Site
      • Sochaczew, Poland, 96-500
        • Completed
        • Novartis Investigative Site
      • Torun, Poland, 87-100
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 02-962
        • Completed
        • Novartis Investigative Site
      • Warsaw, Poland, 04-305
        • Completed
        • Novartis Investigative Site
      • Warsaw, Poland, 02-118
        • Completed
        • Novartis Investigative Site
      • Wroclaw, Poland, 53-224
        • Completed
        • Novartis Investigative Site
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Active, not recruiting
        • Novartis Investigative Site
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Completed
        • Novartis Investigative Site
    • Poland
      • Warsaw, Poland, Poland, 02-637
        • Active, not recruiting
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Completed
        • Novartis Investigative Site
  • Russia
      • Barnaul, Russia, 656024
        • Completed
        • Novartis Investigative Site
      • Chelyabinsk, Russia, 454048
        • Active, not recruiting
        • Novartis Investigative Site
      • Kazan', Russia, 420012
        • Completed
        • Novartis Investigative Site
      • Kazan', Russia, 420064
        • Completed
        • Novartis Investigative Site
      • Kemerovo, Russia, 650029
        • Completed
        • Novartis Investigative Site
      • Kemerovo, Russia, 650070
        • Completed
        • Novartis Investigative Site
      • Krasnodar, Russia, 350020
        • Active, not recruiting
        • Novartis Investigative Site
      • Moscow, Russia, 115522
        • Completed
        • Novartis Investigative Site
      • Moscow, Russia, 119296
        • Completed
        • Novartis Investigative Site
      • Moscow, Russia, 127473
        • Completed
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197022
        • Completed
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 190068
        • Completed
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197198
        • Completed
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197341
        • Completed
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197198
        • Active, not recruiting
        • Novartis Investigative Site
      • Saratov, Russia, 410053
        • Completed
        • Novartis Investigative Site
      • Smolensk, Russia, 214019
        • Completed
        • Novartis Investigative Site
      • Ulyanovsk, Russia, 432063
        • Completed
        • Novartis Investigative Site
      • Yaroslavl, Russia, 150054
        • Completed
        • Novartis Investigative Site
      • Yaroslavl, Russia, 150003
        • Active, not recruiting
        • Novartis Investigative Site
      • Yekaterinburg, Russia, 620023
        • Completed
        • Novartis Investigative Site
      • Yekaterinburg, Russia, 620028
        • Completed
        • Novartis Investigative Site
  • South Africa
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Active, not recruiting
        • Novartis Investigative Site
      • Stellenbosch, Western Cape, South Africa, 7600
        • Completed
        • Novartis Investigative Site
  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Completed
        • Novartis Investigative Site
      • Seoul, Seoul, South Korea, 03080
        • Completed
        • Novartis Investigative Site
  • Spain
      • A Coruña, Spain, 15006
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Completed
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Withdrawn
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Completed
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Active, not recruiting
        • Novartis Investigative Site
    • Andalusia
      • Málaga, Andalusia, Spain, 29009
        • Completed
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Completed
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Completed
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Completed
        • Novartis Investigative Site
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
        • Completed
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Active, not recruiting
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Active, not recruiting
        • Novartis Investigative Site
      • Sankt Gallen, Switzerland, 9007
        • Completed
        • Novartis Investigative Site
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Completed
        • Providence Medical Foundation
      • La Mesa, California, United States, 91942
        • Completed
        • Purushotham Akther and Roshan Kotha MD Inc
      • San Leandro, California, United States, 94578
        • Completed
        • Precn Comprehensive Clnl Rsch Solns
      • Santa Monica, California, United States, 90404
        • Completed
        • Orrin Troum MD and Medical Associates
      • Upland, California, United States, 91786
        • Completed
        • Inland Rheumatology Clinical Trials Inc
      • Van Nuys, California, United States, 91405
        • Completed
        • Medvin Clinical Research
      • Woodland Hills, California, United States, 91364
        • Completed
        • Center for Rheumatology Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Completed
        • Denver Arthritis Clinic
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Rheumatology Associates of South Florida
        • Principal Investigator:
          • Shawn Baca
        • Contact:
      • Homestead, Florida, United States, 33033
        • Completed
        • Homestead Assoc In Research Inc
      • Plantation, Florida, United States, 33324
        • Completed
        • IRIS Research and Development
      • Winter Park, Florida, United States, 32789
        • Completed
        • Conquest Research
      • Zephyrhills, Florida, United States, 33542
        • Recruiting
        • FL Medical Clinic Orlando Health
        • Principal Investigator:
          • Natalie Faith
        • Contact:
    • Illinois
      • Willowbrook, Illinois, United States, 60527
        • Completed
        • Willow Rheumatology Wellness
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Completed
        • Dawes Fretzin Clinical Rea Group
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Completed
        • Klein and Associates
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Completed
        • Ahmed Arif Medical Research Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Completed
        • Physician Research Collaboration
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Completed
        • Arthritis Rheumatology and Bone Disease Associates PA
    • New York
      • Potsdam, New York, United States, 13676
        • Completed
        • St Lawrence Health System
    • Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health Sciences University
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Active, not recruiting
        • Altoona Center for Clin Res
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Active, not recruiting
        • West Tennessee Research Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Completed
        • Austin Regional Clinic Rheumatology
      • Houston, Texas, United States, 77089
        • Active, not recruiting
        • Accurate Clinical Research Inc
      • Mesquite, Texas, United States, 75150
        • Completed
        • Southwest Rheum Rsrch LLC
    • Washington
      • Bellevue, Washington, United States, 98004
        • Completed
        • Overlake Arthritis and Osteoporosis
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Completed
        • Rheumatology Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Secukinumab s.c. injection
Secukinumab pre-filled syringes (PFS) for s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate long term safety as assessed by occurrence of AEs/SAEs
Time Frame: up to 2 years
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Estimated)

January 29, 2030

Study Completion (Estimated)

April 4, 2030

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A02001B
  • 2023-504417-67-00 (Registry Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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