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Secukinumab Open Label Roll-over Extension Protocol

RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Autoimmunity, Inflammation

Interventions: Secukinumab s.c. injection

Countries: United States, Brazil, Bulgaria, China, Colombia, Czechia, Greece, Guatemala

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 overview

Sex: ALL

Age: 6 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (168)

Fullerton, California, United States
La Mesa, California, United States
San Leandro, California, United States
Santa Monica, California, United States
Upland, California, United States
Van Nuys, California, United States
Woodland Hills, California, United States
Denver, Colorado, United States
Boca Raton, Florida, United States
Homestead, Florida, United States
Plantation, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Willowbrook, Illinois, United States
Indianapolis, Indiana, United States
Hagerstown, Maryland, United States
Grand Blanc, Michigan, United States
Lincoln, Nebraska, United States
Voorhees Township, New Jersey, United States
Potsdam, New York, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Jackson, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
Bellevue, Washington, United States
Beckley, West Virginia, United States
Vitória, Espírito Santo, Brazil
Salvador, Estado de Bahia, Brazil
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