A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.
The main objectives of this protocol are:
Study 1 (bDMARD-IR AS) is comprised of a 14-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 90-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day Follow-Up Visit (F/U Visit).
Study 2 (nr-axSpA) is comprised of a 52-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 52-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day F/U Visit.
In the Double-Blind Period for both studies, participants are randomized in a 1:1 ratio to receive either upadacitinib or placebo once daily (QD).
Participants in the placebo group switch to upadacitinib 15 mg QD at Week 14 in the Open-Label Extension Period for Study 1 (bDMARD-IR AS) and Week 52 in the Open-Label Extension Period for Study 2 (nr-axSpA).
Participants in remission at Week 104 have the option to enroll in a remission-withdrawal period.
Study M19-944 protocol uses a common screening platform for determining eligibility into Study 1 and Study 2. Each study has its own objectives, hypothesis testing, randomization, data collection, and adequate power for primary and secondary endpoints. Analysis and reporting are conducted separately and independently for each study.
Inclusion Criteria:
Study 1:
Study 2:
Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits.
Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
Exclusion Criteria:
Flagstaff, Arizona 86001-6269, United States
Skokie, Illinois 60076, United States
Carrollton, Texas 75007, United States
College Station, Texas 77845, United States
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1015, Argentina
Rosario, Santa Fe Province 2000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
São José do Rio Preto, São Paulo 15090-000, Brazil
Shantou, Guangdong 515041, China
Baotou, Inner Mongolia 014016, China
Kormend, Zala County 9900, Hungary
Asahikawa-shi, Hokkaido 070-8644, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Ono-shi, Hyōgo 675-1327, Japan
Kuwana-shi, Mie-ken 511-0061, Japan
Sasebo-shi, Nagasaki 857-1195, Japan
Kawachinagano Shi, Osaka 586-8521, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Chuo-ku, Tokyo 104-8560, Japan
Mexico City, Mexico City 11850, Mexico
Wroclaw, Lower Silesian Voivodeship 51-685, Poland
Korolev, Moscow 141060, Russia
Moscow, Moscow 115522, Russia
Saint Petersburg, Sankt-Peterburg 193015, Russia
Ryazan, 390026, Russia
Sihhiye, Ankara 06100, Turkey (Türkiye)
Chernihiv, 14029, Ukraine
Kharkiv, 61039, Ukraine
Odesa, 65025, Ukraine
Vinnytsia, 21028, Ukraine
Vinnytsia, 21029, Ukraine
Norwich, Norfolk NR4 7UY, United Kingdom
Armthorpe Road, DN2 5LT, United Kingdom