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Long-term treatment with secukinumab for patients who completed a previous trial

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

PHASE4 · Novartis · NCT04638647

This study is testing if long-term treatment with secukinumab can keep helping people with autoimmune and inflammatory conditions who did well in a previous trial.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment1000 (estimated)
Ages6 Years to 100 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionssecukinumab
Locations167 sites (Fullerton, California and 166 other locations)
Trial IDNCT04638647 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the long-term safety of secukinumab in participants who have previously completed a Novartis trial and are deemed by their investigator to benefit from continued treatment. Participants who cannot access the marketed formulation of secukinumab will receive subcutaneous injections of the medication. The study focuses on individuals with autoimmune and inflammatory conditions, ensuring they have provided informed consent before participation. The goal is to provide ongoing treatment for those who have shown positive responses in earlier trials.

Who should consider this trial

Good fit: Ideal candidates are adults and pediatric participants who have completed a Novartis trial of secukinumab and are judged to benefit from ongoing treatment.

Not a fit: Patients who have not previously participated in a Novartis trial of secukinumab or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide continued access to effective treatment for patients with autoimmune conditions who have benefited from secukinumab.

How similar studies have performed: Other studies involving secukinumab have shown positive outcomes, indicating that this approach is built on previously established efficacy.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Fullerton, California and 166 other locations

+117 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Autoimmunity, Inflammation, Secukinumab, Post trial access

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.