NCT04638647 Secukinumab Open Label Roll-over Extension Protocol
| NCT ID | NCT04638647 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Autoimmunity, Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-12-22 |
| Primary Completion | 2030-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,000 participants in total. It began in 2020-12-22 with a primary completion date of 2030-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT04638647 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 100 Years, studying Autoimmunity, Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04638647 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04638647 currently recruiting?
Yes, NCT04638647 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT04638647 trial being conducted?
This trial is being conducted at Fullerton, United States, La Mesa, United States, San Leandro, United States, Santa Monica, United States and 11 additional locations.
Who is sponsoring the NCT04638647 clinical trial?
NCT04638647 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 1,000 participants.