Trials / Completed
CompletedNCT03178487
A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study includes two periods: a 14-week double-blind placebo-controlled period and a 90-week open-label long-term extension period. Eligible participants were randomly assigned in a 1:1 ratio to receive upadacitinib 15 mg or placebo for 14 weeks in Period 1. Participants who completed Period 1 received upadacitinib 15 mg for 90 weeks in the extension period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Upadacitinib | Tablet |
| DRUG | Placebo | Tablet |
Timeline
- Start date
- 2017-10-24
- Primary completion
- 2019-01-21
- Completion
- 2022-02-17
- First posted
- 2017-06-07
- Last updated
- 2023-03-07
- Results posted
- 2021-06-01
Locations
101 sites across 21 countries: United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, South Korea, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03178487. Inclusion in this directory is not an endorsement.