MedDataX Logo

Secukinumab Open Label Roll-over Extension Protocol

NCT ID: NCT04638647

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2030-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmunity, Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Secukinumab, Post trial access

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Secukinumab s.c. injection

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Secukinumab s.c. injection

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Providence Medical Foundation

Fullerton, California, United States

Site Status COMPLETED

Purushotham Akther and Roshan Kotha MD Inc

La Mesa, California, United States

Site Status COMPLETED

Precn Comprehensive Clnl Rsch Solns

San Leandro, California, United States

Site Status COMPLETED

Orrin Troum MD and Medical Associates

Santa Monica, California, United States

Site Status COMPLETED

Inland Rheumatology Clinical Trials INC

Upland, California, United States

Site Status COMPLETED

Medvin Clinical Research

Van Nuys, California, United States

Site Status COMPLETED

Center for Rheumatology Research

West Hills, California, United States

Site Status COMPLETED

Denver Arthritis Clinic

Denver, Colorado, United States

Site Status COMPLETED

Rheumatology Associates of South Florida

Boca Raton, Florida, United States

Site Status RECRUITING

Homestead Assoc In Research Inc

Homestead, Florida, United States

Site Status COMPLETED

IRIS Research and Development

Plantation, Florida, United States

Site Status COMPLETED

Conquest Research

Winter Park, Florida, United States

Site Status COMPLETED

FL Medical Clinic Orlando Health

Zephyrhills, Florida, United States

Site Status RECRUITING

Willow Rheumatology Wellness

Willowbrook, Illinois, United States

Site Status COMPLETED

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, United States

Site Status COMPLETED

Klein and Associates

Hagerstown, Maryland, United States

Site Status COMPLETED

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, United States

Site Status COMPLETED

Physician Research Collaboration

Lincoln, Nebraska, United States

Site Status COMPLETED

Arthritis Rheumatology and Bone Disease Associates PA

Voorhees Township, New Jersey, United States

Site Status COMPLETED

St Lawrence Health System

Potsdam, New York, United States

Site Status COMPLETED

Oregon Health Sciences University

Portland, Oregon, United States

Site Status RECRUITING

Altoona Center for Clin Res

Duncansville, Pennsylvania, United States

Site Status RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status RECRUITING

Austin Regional Clinic Rheumatology

Austin, Texas, United States

Site Status COMPLETED

Southwest Rheum Rsrch LLC

Mesquite, Texas, United States

Site Status COMPLETED

Accurate Clinical Research Inc

San Antonio, Texas, United States

Site Status RECRUITING

Overlake Arthritis and Osteoporosis

Bellevue, Washington, United States

Site Status RECRUITING

Rheumatology Pulmonary Clinic

Beckley, West Virginia, United States

Site Status RECRUITING

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Site Status COMPLETED

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status COMPLETED

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

Site Status COMPLETED

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status COMPLETED

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status COMPLETED

Novartis Investigative Site

Rio de Janeiro, , Brazil

Site Status COMPLETED

Novartis Investigative Site

Sao Jose Rio Preto, , Brazil

Site Status COMPLETED

Novartis Investigative Site

Pleven, , Bulgaria

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Plovdiv, , Bulgaria

Site Status COMPLETED

Novartis Investigative Site

Sofia, , Bulgaria

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sofia, , Bulgaria

Site Status COMPLETED

Novartis Investigative Site

Sofia, , Bulgaria

Site Status COMPLETED

Novartis Investigative Site

Stara Zagora, , Bulgaria

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hefei, Anhui, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hefei, Anhui, China

Site Status RECRUITING

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

Site Status COMPLETED

Novartis Investigative Site

Xiamen, Fujian, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status COMPLETED

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status COMPLETED

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shantou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shenzhen, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Wuhan, Hubei, China

Site Status RECRUITING

Novartis Investigative Site

Changsha, Hunan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Zhuzhou, Hunan, China

Site Status COMPLETED

Novartis Investigative Site

Baotou, Inner Mongolia, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hohhot, Inner Mongolia, China

Site Status COMPLETED

Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yangzhou, Jiangsu, China

Site Status RECRUITING

Novartis Investigative Site

Nanchang, Jiangxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Pingxiang, Jiangxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Changchun, Jilin, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Linyi, Shandong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status RECRUITING

Novartis Investigative Site

Ürümqi, Xinjiang, China

Site Status RECRUITING

Novartis Investigative Site

Kunming, Yunnan, China

Site Status RECRUITING

Novartis Investigative Site

Ningbo, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status COMPLETED

Novartis Investigative Site

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bengbu, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Jinan, , China

Site Status COMPLETED

Novartis Investigative Site

Shanghai, , China

Site Status RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status COMPLETED

Novartis Investigative Site

Tianjin, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Site Status COMPLETED

Novartis Investigative Site

Chía, Cundinamarca, Colombia

Site Status COMPLETED

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Site Status RECRUITING

Novartis Investigative Site

Ibagué, Tolima Department, Colombia

Site Status COMPLETED

Novartis Investigative Site

Ostrava, Czech Republic, Czechia

Site Status RECRUITING

Novartis Investigative Site

Brno-Zidonice, CZE, Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, Prague 1, Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Brno, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Hradec Králové, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Uherské Hradiště, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Pátrai, , Greece

Site Status WITHDRAWN

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status RECRUITING

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status RECRUITING

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status COMPLETED

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status COMPLETED

Novartis Investigative Site

Surat, Gujarat, India

Site Status COMPLETED

Novartis Investigative Site

Bangalore, Karnataka, India

Site Status COMPLETED

Novartis Investigative Site

Mumbai, Maharashtra, India

Site Status COMPLETED

Novartis Investigative Site

Nashik, Maharashtra, India

Site Status COMPLETED

Novartis Investigative Site

Hyderabad, Telangana, India

Site Status COMPLETED

Novartis Investigative Site

New Delhi, , India

Site Status COMPLETED

Novartis Investigative Site

Florence, FI, Italy

Site Status COMPLETED

Novartis Investigative Site

Reggio Emilia, RE, Italy

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Site Status COMPLETED

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Site Status COMPLETED

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Site Status COMPLETED

Novartis Investigative Site

Culiacan, State of Mexico, Mexico

Site Status COMPLETED

Novartis Investigative Site

Metepec, State of Mexico, Mexico

Site Status COMPLETED

Novartis Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

Site Status COMPLETED

Novartis Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status COMPLETED

Novartis Investigative Site

Bialystok, , Poland

Site Status RECRUITING

Novartis Investigative Site

Bydgoszcz, , Poland

Site Status RECRUITING

Novartis Investigative Site

Krakow, , Poland

Site Status RECRUITING

Novartis Investigative Site

Poznan, , Poland

Site Status COMPLETED

Novartis Investigative Site

Sochaczew, , Poland

Site Status COMPLETED

Novartis Investigative Site

Torun, , Poland

Site Status RECRUITING

Novartis Investigative Site

Warsaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Warsaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Warsaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Warsaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Wroclaw, , Poland

Site Status COMPLETED

Novartis Investigative Site

Lisbon, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barnaul, , Russia

Site Status COMPLETED

Novartis Investigative Site

Chelyabinsk, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kazan', , Russia

Site Status COMPLETED

Novartis Investigative Site

Kazan', , Russia

Site Status COMPLETED

Novartis Investigative Site

Kemerovo, , Russia

Site Status COMPLETED

Novartis Investigative Site

Kemerovo, , Russia

Site Status COMPLETED

Novartis Investigative Site

Krasnodar, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status COMPLETED

Novartis Investigative Site

Moscow, , Russia

Site Status COMPLETED

Novartis Investigative Site

Moscow, , Russia

Site Status COMPLETED

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Saratov, , Russia

Site Status COMPLETED

Novartis Investigative Site

Smolensk, , Russia

Site Status COMPLETED

Novartis Investigative Site

Ulyanovsk, , Russia

Site Status COMPLETED

Novartis Investigative Site

Yaroslavl, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yaroslavl, , Russia

Site Status COMPLETED

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status COMPLETED

Novartis Investigative Site

Panorama, Western Cape, South Africa

Site Status COMPLETED

Novartis Investigative Site

Stellenbosch, Western Cape, South Africa

Site Status COMPLETED

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status COMPLETED

Novartis Investigative Site

Seoul, , South Korea

Site Status COMPLETED

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Málaga, Andalusia, Spain

Site Status COMPLETED

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status COMPLETED

Novartis Investigative Site

Bilbao, Bizkaia, Spain

Site Status COMPLETED

Novartis Investigative Site

Santander, Cantabria, Spain

Site Status COMPLETED

Novartis Investigative Site

Vigo, Pontevedra, Spain

Site Status COMPLETED

Novartis Investigative Site

A Coruña, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Seville, , Spain

Site Status WITHDRAWN

Novartis Investigative Site

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status COMPLETED

Novartis Investigative Site

Basel, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bern, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sankt Gallen, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Bulgaria China Colombia Czechia Greece Guatemala India Italy Malaysia Mexico Poland Portugal Russia South Africa South Korea Spain Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Heather Gliatta

Role: primary

William Daily Johnston

Role: primary

Kim Phung Karimzadeh

Role: primary

Pam Morrison

Role: primary

Trina Lawrence

Role: primary

Yanet Martinez

Role: primary

Varsha Sridhar

Role: primary

Tammy McManus

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-504417-67-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAIN457A02001B

Identifier Type: -

Identifier Source: org_study_id