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Secukinumab Open Label Roll-over Extension Protocol

NCT04638647 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Autoimmunity, Inflammation

Interventions

BIOLOGICAL

Secukinumab s.c. injection

Secukinumab pre-filled syringes (PFS) for s.c. injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2030-01-29
Completion
2030-04-04
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Bulgaria
  • China
  • Colombia
  • Czechia
  • Greece
  • Guatemala
  • India
  • Italy
  • Malaysia
  • Mexico
  • Poland
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638647 on ClinicalTrials.gov