Secukinumab Open Label Roll-over Extension Protocol

Last updated: May 5, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Inflammation

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

Secukinumab s.c. injection

Clinical Study ID

NCT04638647
CAIN457A02001B
2023-504417-67-00
2020-004284-98
  • Ages 6-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent must be obtained for adult participants before anyassessment is performed. Written informed assent and parental permission (age as perlocal law) must be obtained for pediatric participants before any assessment isperformed. If participants reach age of consent (age as per local law) during thestudy, they will need to also sign the corresponding study informed consent(s).

  2. Ability to communicate effectively with the investigator, to understand and willingto 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 derivebenefit from the treatment with secukinumab but have not completed the treatment incertain parent studies, due to parent study termination by Novartis, may be eligibleif 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 wouldcontinue 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 perlocal prescription and/or reimbursement guidelines.

Exclusion

Exclusion Criteria:

  1. Participant has prematurely discontinued study treatment in the parent protocol.

  2. Women of childbearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using methods of contraception during the entirestudy or longer if required by locally approved prescribing information (e.g., inEuropean Union (EU) 20 weeks).

Study Design

Total Participants: 715
Treatment Group(s): 1
Primary Treatment: Secukinumab s.c. injection
Phase: 4
Study Start date:
December 22, 2020
Estimated Completion Date:
April 04, 2030

Connect with a study center

  • Novartis Investigative Site

    Salvador, BA 40150 150
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Vitoria, ES 29055 450
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Juiz de Fora, MG 36010 570
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Paulo, SP 04266 010
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    São Paulo, SP 01244-030
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Rio de Janeiro, 20241-180
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Stara Zagora, 6000
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Hefei, Anhui 230601
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chongqing, Chongqing 400010
    China

    Active - Recruiting

  • Novartis Investigative Site

    Xiamen, Fujian 361001
    China

    Active - Recruiting

  • Novartis Investigative Site

    Guang Zhou, Guangdong 510120
    China

    Active - Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Novartis Investigative Site

    Shantou, Guangdong 515041
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shenzhen, Guangdong 518020
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Novartis Investigative Site

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Novartis Investigative Site

    Zhuzhou, Hunan 412000
    China

    Site Not Available

  • Novartis Investigative Site

    Baotou, Inner Mongolia 014010
    China

    Active - Recruiting

  • Novartis Investigative Site

    Hohhot, Inner Mongolia 10050
    China

    Active - Recruiting

  • Novartis Investigative Site

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Novartis Investigative Site

    Yangzhou, Jiangsu 225001
    China

    Active - Recruiting

  • Novartis Investigative Site

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Novartis Investigative Site

    Pingxiang, Jiangxi 337000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chang Chun, Jilin 130021
    China

    Active - Recruiting

  • Novartis Investigative Site

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Novartis Investigative Site

    Urumqi, Xinjiang 830001
    China

    Active - Recruiting

  • Novartis Investigative Site

    KunMing, Yun Nan 650000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100050
    China

    Active - Recruiting

  • Novartis Investigative Site

    Bengbu, 233004
    China

    Site Not Available

  • Novartis Investigative Site

    Jinan, 250012
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shanghai, 200050
    China

    Active - Recruiting

  • Novartis Investigative Site

    Tianjin, 300052
    China

    Active - Recruiting

  • Novartis Investigative Site

    Zhejiang, 315016
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chia, Cundinamarca 250001
    Colombia

    Completed

  • Novartis Investigative Site

    Bucaramanga, Santander 0001
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Ibague, Tolima 730006
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Bogota, 110221
    Colombia

    Completed

  • Novartis Investigative Site

    Cundinamarca, 111121
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Brno-Zidonice, CZE 61500
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Hradec Kralove, CZE 500 05
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Ostrava, Czech Republic 772 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Prague, Prague 1 11000
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Brno Bohunice, 625 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Prague 4, 14059
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha 11, 14900
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha 2, 128 50
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha 4, 140 59
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha 5, 150 06
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Patra, 26443
    Greece

    Site Not Available

  • Novartis Investigative Site

    Guatemala, 01001
    Guatemala

    Active - Recruiting

  • Novartis Investigative Site

    Guatemala City, 01011
    Guatemala

    Site Not Available

  • Novartis Investigative Site

    Surat, Gujarat 395009
    India

    Completed

  • Novartis Investigative Site

    Bangalore, Karnataka 560 079
    India

    Completed

  • Novartis Investigative Site

    Mumbai, Maharashtra 400 053
    India

    Completed

  • Novartis Investigative Site

    Nashik, Maharashtra 422101
    India

    Completed

  • Novartis Investigative Site

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Novartis Investigative Site

    New Delhi, 110029
    India

    Completed

  • Novartis Investigative Site

    Firenze, FI 50134
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Reggio Emilia, RE 42123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Completed

  • Novartis Investigative Site

    Kuching, Sarawak 93586
    Malaysia

    Completed

  • Novartis Investigative Site

    Kuala Lumpur, 59100
    Malaysia

    Completed

  • Novartis Investigative Site

    Metepec, Estado De Mexico 52140
    Mexico

    Completed

  • Novartis Investigative Site

    Guadalajara, Jalisco 44160
    Mexico

    Completed

  • Novartis Investigative Site

    Culiacan, MEX 80000
    Mexico

    Completed

  • Novartis Investigative Site

    Krakow, Malopolskie 30-727
    Poland

    Completed

  • Novartis Investigative Site

    Bialystok, 15-351
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Karwiany, 52-200
    Poland

    Site Not Available

  • Novartis Investigative Site

    Poznan, 60-218
    Poland

    Completed

  • Novartis Investigative Site

    Sochaczew, 96-500
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Torun, 87-100
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Warszawa, 02 118
    Poland

    Completed

  • Novartis Investigative Site

    Wroclaw, 53-224
    Poland

    Completed

  • Novartis Investigative Site

    Lisboa, 1649 035
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Barnaul, 656024
    Russian Federation

    Completed

  • Novartis Investigative Site

    Chelyabinsk, 454048
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ekaterinburg, 620028
    Russian Federation

    Completed

  • Novartis Investigative Site

    Kazan, 420012
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kemerovo, 650070
    Russian Federation

    Completed

  • Novartis Investigative Site

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Moscow, 119296
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 197341
    Russian Federation

    Completed

  • Novartis Investigative Site

    Saratov, 410053
    Russian Federation

    Completed

  • Novartis Investigative Site

    Smolensk, 214019
    Russian Federation

    Completed

  • Novartis Investigative Site

    St Petersburg, 190068
    Russian Federation

    Completed

  • Novartis Investigative Site

    Ulyanovsk, 432063
    Russian Federation

    Completed

  • Novartis Investigative Site

    Yaroslavl, 150003
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    Panorama, Western Cape 7500
    South Africa

    Active - Recruiting

  • Novartis Investigative Site

    Stellenbosch, 7600
    South Africa

    Active - Recruiting

  • Novartis Investigative Site

    Malaga, Andalucia 29009
    Spain

    Completed

  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Completed

  • Novartis Investigative Site

    Santander, Cantabria 39008
    Spain

    Completed

  • Novartis Investigative Site

    La Coruna, Galicia 15006
    Spain

    Completed

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Bilbao, Pais Vasco 48013
    Spain

    Completed

  • Novartis Investigative Site

    Vigo, Pontevedra 36200
    Spain

    Completed

  • Novartis Investigative Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Completed

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    St Gallen, 9007
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Completed

  • Providence Medical Foundation .

    Fullerton, California 92835
    United States

    Completed

  • Novartis Investigative Site

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Purushotham Akther and Roshan Kotha MD Inc

    La Mesa, California 91942
    United States

    Completed

  • Novartis Investigative Site

    San Leandro, California 94578
    United States

    Active - Recruiting

  • Precn Comprehensive Clnl Rsch Solns

    San Leandro, California 94578
    United States

    Completed

  • Novartis Investigative Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Orrin Troum MD and Medical Associates

    Santa Monica, California 90404
    United States

    Completed

  • Inland Rheumatology Clinical Trials INC

    Upland, California 91786
    United States

    Completed

  • Novartis Investigative Site

    Upland, California 91786
    United States

    Site Not Available

  • Medvin Clinical Research

    Van Nuys, California 91405
    United States

    Completed

  • Medvin Clinical Research .

    Van Nuys, California 91405
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Van Nuys, California 91405
    United States

    Active - Recruiting

  • Center for Rheumatology Research

    West Hills, California 91307
    United States

    Completed

  • Center for Rheumatology Research Rheumatology

    West Hills, California 91307
    United States

    Active - Recruiting

  • Novartis Investigative Site

    West Hills, California 91307
    United States

    Active - Recruiting

  • Denver Arthritis Clinic

    Denver, Colorado 80230
    United States

    Completed

  • Denver Arthritis Clinic .

    Denver, Colorado 80230
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Denver, Colorado 80230
    United States

    Active - Recruiting

  • Rheumatology Associates of South Florida

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Homestead Assoc In Research Inc

    Homestead, Florida 33033
    United States

    Completed

  • Homestead Associates in Research Inc

    Miami, Florida 33032
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami, Florida 33032
    United States

    Active - Recruiting

  • IRIS Research and Development

    Plantation, Florida 33324
    United States

    Completed

  • Integral Rheumatology and Immunology Specialists IRIS

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Completed

  • Novartis Investigative Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • FL Medical Clinic Orlando Health

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • FL Medical Clinic Orlando Health .

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Illinois Bone And Joint Institute

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Willow Rheumatology Wellness

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana 46256
    United States

    Completed

  • Dawes Fretzin Clinical Rea Group .

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Klein and Associates Rheumatology

    Cumberland, Maryland 21740
    United States

    Site Not Available

  • Novartis Investigative Site

    Cumberland, Maryland 21740
    United States

    Active - Recruiting

  • Klein and Associates

    Hagerstown, Maryland 21740
    United States

    Completed

  • Klein and Associates Rheumatology

    Hagerstown, Maryland 21740
    United States

    Completed

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan 48439
    United States

    Completed

  • Novartis Investigative Site

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Physician Research Collaboration

    Lincoln, Nebraska 68516
    United States

    Completed

  • Physician Research Collaboration .

    Lincoln, Nebraska 68516
    United States

    Completed

  • Athritis Rheumatology and Back Disease Associates PA

    Voorhees, New Jersey 08043
    United States

    Completed

  • Athritis Rheumatology and Back Disease Associates PA .

    Voorhees, New Jersey 08043
    United States

    Completed

  • Athritis, Rheumatology and Back Disease Associates, PA .

    Voorhees, New Jersey 08043
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Voorhees, New Jersey 08043
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Potsdam, New York 13676
    United States

    Site Not Available

  • St Lawrence Health System

    Potsdam, New York 13676
    United States

    Completed

  • St Lawrence Health System Medical Campus

    Potsdam, New York 13676
    United States

    Site Not Available

  • Novartis Investigative Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Altoona Center for Clin Res

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Altoona Center for Clin Res .

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Novartis Investigative Site

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Novartis Investigative Site

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Austin Regional Clinic Rheumatology

    Austin, Texas 78731
    United States

    Completed

  • Novartis Investigative Site

    Austin, Texas 78731
    United States

    Completed

  • Novartis Investigative Site

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Southwest Rheum Rsrch LLC

    Mesquite, Texas 75150
    United States

    Completed

  • Southwest Rheumatology Research LLC

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Accurate Clinical Research Inc

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Accurate Clinical Research Inc .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Overlake Internal Med Associates

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Rheumatology Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

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