Secukinumab Open Label Roll-over Extension Protocol
Launched by NOVARTIS PHARMACEUTICALS · Nov 16, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The Secukinumab Open Label Roll-over Extension Protocol is a clinical trial that aims to understand the long-term safety of a medication called secukinumab for people with autoimmune and inflammatory conditions. This study is for participants who have previously taken part in a Novartis trial using secukinumab, found it helpful, and are now unable to access the treatment through regular channels. The researchers want to ensure that those who benefit from this medication can continue to receive it safely.
To be eligible for this study, participants must be adults or children (with appropriate permissions), have completed a prior Novartis trial of secukinumab, and still be experiencing benefits from the treatment. It is important that participants can communicate effectively with the study team and understand the study's requirements. During this trial, participants will receive secukinumab and be closely monitored for any side effects or safety concerns. If you're considering participating, know that this study is currently recruiting and is open to all genders.
Gender
ALL
Eligibility criteria
- 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).
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Duncansville, Pennsylvania, United States
Denver, Colorado, United States
Bern, , Switzerland
Portland, Oregon, United States
Fullerton, California, United States
Voorhees, New Jersey, United States
Basel, , Switzerland
Portland, Oregon, United States
Hospitalet De Llobregat, Barcelona, Spain
Santander, Cantabria, Spain
La Coruna, Galicia, Spain
Wuhan, Hubei, China
Van Nuys, California, United States
Austin, Texas, United States
Guangzhou, Guangdong, China
Kuala Lumpur, , Malaysia
Valencia, , Spain
St Gallen, , Switzerland
Torun, , Poland
Santa Monica, California, United States
Jackson, Tennessee, United States
Winter Park, Florida, United States
Firenze, Fi, Italy
Seoul, , Korea, Republic Of
Saint Petersburg, , Russian Federation
Santiago De Compostela, Galicia, Spain
Bilbao, Pais Vasco, Spain
San Leandro, California, United States
Mesquite, Texas, United States
Praha 4, , Czechia
New Delhi, , India
Plantation, Florida, United States
Beijing, Beijing, China
Nanjing, Jiangsu, China
Chengdu, Sichuan, China
Tianjin, , China
Guatemala City, , Guatemala
Sevilla, Andalucia, Spain
Valencia, , Spain
Lincoln, Nebraska, United States
Duncansville, Pennsylvania, United States
Indianapolis, Indiana, United States
Austin, Texas, United States
Shanghai, , China
Hradec Kralove, Cze, Czechia
Reggio Emilia, Re, Italy
Jackson, Tennessee, United States
Pleven, , Bulgaria
Beijing, , China
Guangzhou, Guangdong, China
Jinan, , China
Hyderabad, Telangana, India
Chelyabinsk, , Russian Federation
Ekaterinburg, , Russian Federation
Moscow, , Russian Federation
Madrid, , Spain
Yaroslavl, , Russian Federation
Kazan, , Russian Federation
Lincoln, Nebraska, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Kuching, Sarawak, Malaysia
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Kemerovo, , Russian Federation
Smolensk, , Russian Federation
Barnaul, , Russian Federation
Nanchang, Jiangxi, China
Shanghai, , China
Grand Blanc, Michigan, United States
Chongqing, Chongqing, China
Brno Bohunice, , Czechia
Upland, California, United States
Van Nuys, California, United States
Guadalajara, Jalisco, Mexico
Bialystok, , Poland
Poznan, , Poland
Hefei, Anhui, China
Bucaramanga, Santander, Colombia
Mumbai, Maharashtra, India
Denver, Colorado, United States
Miami, Florida, United States
Praha 5, , Czechia
São Paulo, Sp, Brazil
Ulyanovsk, , Russian Federation
Bogota, , Colombia
Changsha, Hunan, China
Guatemala, , Guatemala
Ostrava, Czech Republic, Czechia
Uherske Hradiste, , Czechia
St Petersburg, , Russian Federation
Krakow, Malopolskie, Poland
Panorama, Western Cape, South Africa
Guang Zhou, Guangdong, China
Chang Chun, Jilin, China
Lisboa, , Portugal
Sao Paulo, Sp, Brazil
Shantou, Guangdong, China
Saratov, , Russian Federation
Wenzhou, Zhejiang, China
Praha 2, , Czechia
Culiacan, Mex, Mexico
Upland, California, United States
Kemerovo, , Russian Federation
Boca Raton, Florida, United States
Plantation, Florida, United States
Metepec, Estado De Mexico, Mexico
Kazan, , Russian Federation
Vigo, Pontevedra, Spain
Malaga, Andalucia, Spain
Sao Jose Do Rio Preto, , Brazil
Krasnodar, , Russian Federation
Saint Petersburg, , Russian Federation
Guang Zhou, , China
Warszawa, , Poland
Wroclaw, , Poland
Mesquite, Texas, United States
Potsdam, New York, United States
Brno Zidonice, Cze, Czechia
La Mesa, California, United States
Bilbao, Bizkaia, Spain
Malaga, , Spain
Xiamen, Fujian, China
Urumqi, Xinjiang, China
Bengbu, , China
West Hills, California, United States
Ibague, Tolima, Colombia
Winter Park, Florida, United States
Hagerstown, Maryland, United States
Praha 11, , Czechia
Cumberland, Maryland, United States
Shenzhen, Guangdong, China
Prague, Prague 1, Czechia
Ekaterinburg, , Russian Federation
Fullerton, California, United States
Rio De Janeiro, , Brazil
Vitoria, Es, Brazil
Juiz De Fora, Mg, Brazil
Salvador, Ba, Brazil
Cundinamarca, , Colombia
Patra, , Greece
Surat, Gujarat, India
Bangalore, Karnataka, India
Sochaczew, , Poland
Nashik, Maharashtra, India
Karwiany, , Poland
Stellenbosch, , South Africa
Potsdam, New York, United States
Prague 4, , Czechia
Baotou, Inner Mongolia, China
Hohhot, Inner Mongolia, China
Pingxiang, Jiangxi, China
Linyi, Shandong, China
Kunming, Yun Nan, China
Miami, Florida, United States
West Hills, California, United States
Wroclaw, Dolnoslaskie, Poland
Praha 11, , Czechia
Zhuzhou, Hunan, China
Zhejiang, , China
Yangzhou, Jiangsu, China
Krakow, Malopolskie, Poland
Van Nuys, California, United States
Plantation, Florida, United States
Grand Blanc, Michigan, United States
West Hills, California, United States
Cumberland, Maryland, United States
Fullerton, California, United States
La Mesa, California, United States
San Leandro, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
Indianapolis, Indiana, United States
Lincoln, Nebraska, United States
Voorhees, New Jersey, United States
Potsdam, New York, United States
Duncansville, Pennsylvania, United States
Hinsdale, Illinois, United States
Beckley, West Virginia, United States
Chia, Cundinamarca, Colombia
Duncansville, Pennsylvania, United States
Mesquite, Texas, United States
Sao Paulo, Sp, Brazil
Voorhees, New Jersey, United States
Zephyrhills, Florida, United States
San Antonio, Texas, United States
Zephyrhills, Florida, United States
Homestead, Florida, United States
Hagerstown, Maryland, United States
Indianapolis, Indiana, United States
Voorhees, New Jersey, United States
Austin, Texas, United States
San Antonio, Texas, United States
Bellevue, Washington, United States
Willowbrook, Illinois, United States
Prague, , Czechia
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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