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RecruitingPhase 4

Secukinumab Open Label Roll-over Extension Protocol

Novartis Pharmaceuticals · NCT04638647

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 4
Target enrollment
1000
US sites recruiting
2
Study start
December 22, 2020
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Secukinumab s.c. injection

Conditions: Autoimmunity, Inflammation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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).
  • Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
  • 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).
  • 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.
  • Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion Criteria

  • Participant has prematurely discontinued study treatment in the parent protocol.
  • 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).

Recruiting US locations

  • Rheumatology Associates of South Florida

    Boca Raton, FL 33486

    Site contact: Heather Gliatta · +1 561 361 6547 · Heathrah17@yahoo.com

  • FL Medical Clinic Orlando Health

    Zephyrhills, FL 33542

    Site contact: William Daily Johnston · +1 813 782 1234 · william.johnston@orlandohealth.com

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
Secukinumab Open Label Roll-over Extension Protocol (NCT04638647) | Bored Studies