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Clinical Trials in the USA / NCT04638647
Recruiting Phase 4

Secukinumab Open Label Roll-over Extension Protocol

NCT04638647 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2020-12-22
Last updated
2026-08-18

Condition(s) studied

Autoimmunity, Inflammation

Investigational drug(s) / intervention(s)

Secukinumab s.c. injection

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

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

Sex
ALL
Min age
6 Years
Max age
100 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (168)

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

+ 128 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04638647 on ClinicalTrials.gov ↗ ← All trials in the USA