M19-944- Axial Spondyloarthritis: Evaluation of Upadacitinib in Adults
Research type
Research Study
Full title
M19-944: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis
IRAS ID
273949
Contact name
Natalia Tomkiewicz
Contact email
Sponsor organisation
AbbVie UK
Eudract number
2019-003229-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 21 days
Research summary
Axial spondyloarthritis (axSpA) is a chronic form of arthritis that causes significant inflammatory low back and/ or buttock pain. AxSpA is an umbrella term for non-radiographic axSpA (Nr-axSpA) and Ankylosing Spondylitis (AS). Nr-axSpA is the earlier form of the disease, which can progress to AS.
There remains a significant unmet medical need in the treatment of axSpA. To date, there have been no oral targeted therapies approved for the treatment of axSpA. Phase 2 data suggests that inhibition of JAK-mediated pathways may be a promising approach for the treatment of patients with AS.
The purpose of the study is to evaluate the safety and effectiveness of a new oral medication (upadacitinib) compared with placebo (dummy drug) on reduction of signs and symptoms in adult patients with active axSpA.
This study comprises of 2 separate studies. Study 1 is in patients with active AS who had an inadequate response to biologic disease-modifying antirheumatic drug therapy (bDMARD-IR) and Study 2 is in subjects with active nr-axSpA.
All patients will undergo a screening process up to a maximum of 35 days.
Study 1 (bDMARD-IR AS); patients will be randomly placed onto treatment for 14 weeks to either placebo or upadacitinib Dose A in a blinded fashion (no one will know what treatment the patient is getting). At week 14, patients will be given open-label (treatment is known) dose A for an additional 90 weeks.
Study 2 (nr-axSpA); patients will be randomly placed onto treatment for 52 weeks to either placebo or upadacitinib Dose A in a blinded fashion. At week 52, patients will be given open-label dose A for an additional 52 weeks.
All patients will have a final clinic visit 30 days after the last dose of the oral study drug to follow-up on any new or ongoing side effects.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0049
Date of REC Opinion
2 Mar 2020
REC opinion
Favourable Opinion