NCT04638647From ClinicalTrials.govRecruiting

Secukinumab Open Label Roll-over Extension Protocol

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

Autoimmunity, Inflammation

At a glance

Phase: Phase 4
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 1,000
Started: 22 December 2020
Main results due: 29 January 2030
Study sites: 169
Registry updated: 28 September 2026

Can you take part?

Ages 6 years to 100 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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).

What this study is about

In the sponsor’s own words, from the registry.

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 sites(169)

Providence Medical Foundation
Fullerton, California, United States
Completed
Purushotham Akther and Roshan Kotha MD Inc
La Mesa, California, United States
Completed
Precn Comprehensive Clnl Rsch Solns
San Leandro, California, United States
Completed
Orrin Troum MD and Medical Associates
Santa Monica, California, United States
Completed
Inland Rheumatology Clinical Trials INC
Upland, California, United States
Completed
Medvin Clinical Research
Van Nuys, California, United States
Completed
Center for Rheumatology Research
Woodland Hills, California, United States
Completed
Denver Arthritis Clinic
Denver, Colorado, United States
Completed
Rheumatology Associates of South Florida
Boca Raton, Florida, United States
Recruiting
Homestead Assoc In Research Inc
Homestead, Florida, United States
Completed
IRIS Research and Development
Plantation, Florida, United States
Completed
Conquest Research
Winter Park, Florida, United States
Completed
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Recruiting
Willow Rheumatology Wellness
Willowbrook, Illinois, United States
Completed
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
Completed
Klein and Associates
Hagerstown, Maryland, United States
Completed
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Completed
Physician Research Collaboration
Lincoln, Nebraska, United States
Completed
Arthritis Rheumatology and Bone Disease Associates PA
Voorhees Township, New Jersey, United States
Completed
St Lawrence Health System
Potsdam, New York, United States
Completed
Oregon Health Sciences University
Portland, Oregon, United States
Completed
Altoona Center for Clin Res
Duncansville, Pennsylvania, United States
Active, not recruiting
West Tennessee Research Institute
Jackson, Tennessee, United States
Active, not recruiting
Austin Regional Clinic Rheumatology
Austin, Texas, United States
Completed
Accurate Clinical Research Inc
Houston, Texas, United States
Active, not recruiting
Southwest Rheum Rsrch LLC
Mesquite, Texas, United States
Completed
Overlake Arthritis and Osteoporosis
Bellevue, Washington, United States
Completed
Rheumatology Pulmonary Clinic
Beckley, West Virginia, United States
Completed
Novartis Investigative Site
Vitória, Espírito Santo, Brazil
Completed
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Completed
Novartis Investigative Site
Juiz de Fora, Minas Gerais, Brazil
Completed
Novartis Investigative Site
São José do Rio Preto, São Paulo, Brazil
Completed
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Completed
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Completed
Novartis Investigative Site
Rio de Janeiro, Brazil
Completed
Novartis Investigative Site
Plovdiv, Bulgaria, Bulgaria
Completed
Novartis Investigative Site
Sofia, Bulgaria, Bulgaria
Active, not recruiting
Novartis Investigative Site
Stara Zagora, Bulgaria, Bulgaria
Active, not recruiting
Novartis Investigative Site
Pleven, Bulgaria
Active, not recruiting
Novartis Investigative Site
Sofia, Bulgaria
Completed
Novartis Investigative Site
Sofia, Bulgaria
Completed
Novartis Investigative Site
Hefei, Anhui, China
Active, not recruiting
Novartis Investigative Site
Hefei, Anhui, China
Active, not recruiting
Novartis Investigative Site
Beijing, Beijing Municipality, China
Active, not recruiting
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Completed
Novartis Investigative Site
Xiamen, Fujian, China
Active, not recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
Completed
Novartis Investigative Site
Guangzhou, Guangdong, China
Completed
Novartis Investigative Site
Guangzhou, Guangdong, China
Active, not recruiting
Novartis Investigative Site
Shantou, Guangdong, China
Active, not recruiting
Novartis Investigative Site
Shenzhen, Guangdong, China
Active, not recruiting
Novartis Investigative Site
Wuhan, Hubei, China
Active, not recruiting
Novartis Investigative Site
Changsha, Hunan, China
Active, not recruiting
Novartis Investigative Site
Zhuzhou, Hunan, China
Completed
Novartis Investigative Site
Baotou, Inner Mongolia, China
Active, not recruiting
Novartis Investigative Site
Hohhot, Inner Mongolia, China
Completed
Novartis Investigative Site
Nanjing, Jiangsu, China
Active, not recruiting
Novartis Investigative Site
Nanjing, Jiangsu, China
Active, not recruiting
Novartis Investigative Site
Yangzhou, Jiangsu, China
Active, not recruiting
Novartis Investigative Site
Nanchang, Jiangxi, China
Completed

Showing 60 of 169 sites — filter to narrow it down. 16 of the 169 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04638647. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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