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Long-Term Safety of Secukinumab for Autoimmune Inflammation

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial is for people who have completed a Novartis trial for secukinumab, and the study is to assess the long term safety for these participants.

Who is the study for?
This trial is for people who have benefited from Secukinumab in a previous Novartis study, can't get it commercially due to local guidelines, and are judged by the researcher to still benefit from it. It's not for those who stopped early in the earlier study or women able to have children not using contraception.
What is being tested?
The trial continues treatment with Secukinumab injections for patients previously on it, aiming to assess long-term safety. Participants must have completed an earlier Novartis trial and be unable to obtain the drug otherwise.
What are the potential side effects?
While specific side effects aren't listed here, as this is an extension of prior trials, typical reactions may include injection site reactions, increased infection risk, and potential autoimmune responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate long term safety as assessed by occurrence of AEs/SAEs

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Secukinumab s.c.Experimental Treatment1 Intervention
Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,251,988 Total Patients Enrolled

Media Library

Secukinumab s.c. injection Clinical Trial Eligibility Overview. Trial Name: NCT04638647 — Phase 4
Autoimmune Inflammation Research Study Groups: Secukinumab s.c.
Autoimmune Inflammation Clinical Trial 2023: Secukinumab s.c. injection Highlights & Side Effects. Trial Name: NCT04638647 — Phase 4
Secukinumab s.c. injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04638647 — Phase 4
~315 spots leftby Dec 2027
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