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NCT03350815 · ClinicalTrials.gov registry record · Phase 4

Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis

A Phase 4 study of Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
322
Enrollment target
20
Study locations

NCT03350815: Completed Phase 4 study of Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals.

NCT03350815 is a Phase 4 study of Ankylosing Spondylitis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 322 participants, below the 38,176-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03350815, a Phase 4 study of Ankylosing Spondylitis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
322 participants
Enrollment target
20
Study locations

Study Summary

This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

Primary Outcome

Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease a

Conditions Studied

Ankylosing Spondylitis

Interventions

  • DRUG 150 mg open-label secukinumab
  • DRUG 150 mg double-blinded secukinumab
  • DRUG 300 mg double-blinded secukinumab

Study Locations (20)

Florida

  • Novartis Investigative Site - Aventura
  • Novartis Investigative Site - Boca Raton
  • Novartis Investigative Site - Brandon
  • Novartis Investigative Site - DeLand
  • Novartis Investigative Site - Gainesville
  • Novartis Investigative Site - Orlando
  • Novartis Investigative Site - Plantation
  • Novartis Investigative Site - St. Petersburg
  • Novartis Investigative Site - Tamarac
  • Novartis Investigative Site - Tampa
  • Novartis Investigative Site - Zephyrhills

California

  • Novartis Investigative Site - Fullerton
  • Novartis Investigative Site - Loma Linda
  • Novartis Investigative Site - Palm Desert
  • Novartis Investigative Site - Tustin
  • Novartis Investigative Site - Upland

Illinois

  • Novartis Investigative Site - Springfield
  • Novartis Investigative Site - Vernon Hills

Arkansas

  • Novartis Investigative Site - Jonesboro

Georgia

  • Novartis Investigative Site - Duluth

Trial Details

FieldValue
Enrollment Target 322 participants
Start Date 2018-03-13
Est. Completion 2021-05-29
Phase Phase 4
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03350815 record still lists

NCT03350815 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, below the 38,176-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Ankylosing Spondylitis appearing as the primary indexed condition, and to 3 interventions - of which 150 mg open-label secukinumab is the first listed.

NCT03350815 names 20 study sites across 5 states, led by Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT03350815 about?

NCT03350815 is a clinical study titled "Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis". This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

What is the current status of trial NCT03350815?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 322 participants. The study started on 2018-03-13. Estimated completion is 2021-05-29.

What conditions does trial NCT03350815 study?

This clinical trial studies the following conditions: Ankylosing Spondylitis.

What interventions are being tested in trial NCT03350815?

The interventions under investigation include: 150 mg open-label secukinumab (DRUG), 150 mg double-blinded secukinumab (DRUG), 300 mg double-blinded secukinumab (DRUG).

Who is sponsoring clinical trial NCT03350815?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03350815 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Ankylosing Spondylitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03350815's enrollment target sits among peer trials

322 10th of 15 higher than 6 of 15 other Ankylosing Spondylitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ankylosing Spondylitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03350815, the US trial registry maintained by the National Library of Medicine. NCT03350815 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.