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

Conditions

• Spondyloarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Upadacitinib tablet administered orally
• Placebo — DRUG
  Placebo for upadacitinib tablet administered orally

Study Details

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.

Key Dates

Start date

Nov 26, 2019

Status verified

Feb 2025

Primary completion

Sep 2, 2021

Completion

Feb 28, 2025

Study Design

Enrollment

734 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Study 1: Upadacitinib 15 mg
  Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
• Placebo Comparator: Study 1: Placebo
  Participants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
• Experimental: Study 2: Upadacitinib 15 mg
  Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
• Placebo Comparator: Study 2: Placebo
  Participants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Primary Outcome Measure

Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14 [ Time Frame: Baseline and Week 14 ]

Locations (41)

Find similar trials in Flagstaff, AZ

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