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NCT03178487 · ClinicalTrials.gov registry record · Phase 2

A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

A Phase 2 study, sponsored by AbbVie.

Completed
Registry status
Phase 2
Development phase
187
Enrollment target

NCT03178487: Completed Phase 2 study, sponsored by AbbVie.

NCT03178487 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03178487, a Phase 2 study, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 2
Development phase
187 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Primary Outcome

ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); *

Interventions

  • DRUG Placebo
  • DRUG Upadacitinib

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2017-10-24
Est. Completion 2022-02-17
Phase Phase 2
AbbVie

526 total trials

What the finished NCT03178487 record still lists

NCT03178487 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03178487 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03178487 about?

NCT03178487 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis". The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are na...

What is the current status of trial NCT03178487?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2017-10-24. Estimated completion is 2022-02-17.

What interventions are being tested in trial NCT03178487?

The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG).

Who is sponsoring clinical trial NCT03178487?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03178487's enrollment target sits among peer trials

187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03178487, the US trial registry maintained by the National Library of Medicine. NCT03178487 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.