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A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

NCT04169373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 734

Last updated 2026-02-24

Study results available
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Summary

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.

The main objectives of this protocol are:

* To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
* To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).
* To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).
* To evaluate the maintenance of disease control after withdrawal of upadacitinib.

Conditions

  • Spondyloarthritis

Interventions

DRUG

Upadacitinib

Upadacitinib tablet administered orally

DRUG

Placebo

Placebo for upadacitinib tablet administered orally

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2021-09-02
Completion
2025-02-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04169373 on ClinicalTrials.gov