A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Launched by ABBVIE · Nov 18, 2019
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Study 1:
- • Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS,
- • Must not have total spinal ankylosis
- • Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor \[TNF\] inhibitor or 1 interleukin \[IL\]-17 inhibitor \[IL-17i\]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs
- * Study 2:
- • Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS
- • Must have objective signs of active inflammation consistent with axSpA on magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high sensitivity C-reactive protein (hsCRP) \> the upper limit of normal (ULN).
- • Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is allowed for at least 20% but no more than 35% of enrolled patients who had to discontinue the prior bDMARD due to either lack of efficacy (after ≥ 12 weeks at an adequate dose) or intolerance (regardless of treatment duration).
- • 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:
- • Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib \[Rinvoq®\], tofacitinib \[Xeljanz®\], baricitinib \[Olumiant®\], filgotinib, ruxolitinib \[Jakafi®\], abrocitinib \[PF-04965842\], and peficitinib \[Smyraf®\]).
- • Prior bDMARD therapy must be washed out.
- • Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Flagstaff, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Huntington Beach, California, United States
Upland, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Aventura, Florida, United States
Hialeah, Florida, United States
Palmetto Bay, Florida, United States
Winter Park, Florida, United States
Chicago, Illinois, United States
Schaumburg, Illinois, United States
Skokie, Illinois, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Eagan, Minnesota, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
New York, New York, United States
Potsdam, New York, United States
Leland, North Carolina, United States
Marietta, Ohio, United States
Springboro, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Austin, Texas, United States
Carrollton, Texas, United States
College Station, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Plano, Texas, United States
Beckley, West Virginia, United States
South Charleston, West Virginia, United States
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Cordoba, , Argentina
Cordoba, , Argentina
San Miguel De Tucuman, , Argentina
Botany, New South Wales, Australia
Paramatta, New South Wales, Australia
Camberwell, Victoria, Australia
Clayton, Victoria, Australia
Geelong, Victoria, Australia
Gent, Oost Vlaanderen, Belgium
Leuven, Vlaams Brabant, Belgium
Genk, , Belgium
Juiz De Fora, Minas Gerais, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Jose Do Rio Preto, Sao Paulo, Brazil
Sao Paulo, , Brazil
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Victoria, British Columbia, Canada
Toronto, Ontario, Canada
Montréal, Quebec, Canada
Trois Rivières, Quebec, Canada
Quebec, , Canada
Bengbu, Anhui, China
Hefei, Anhui, China
Beijing, Beijing, China
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Shenzhen, Guangdong, China
Zhuzhou, Hunan, China
Baotou, Inner Mongolia, China
Kunming, , China
Shanghai, , China
Soochow, , China
Brno, , Czechia
Brno, , Czechia
Brno, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Uherske Hradiste, , Czechia
Toulouse, Occitanie, France
Bordeaux, , France
Boulogne Billancourt, , France
Paris, , France
Erlangen, Bayern, Germany
Berlin, , Germany
Berlin, , Germany
Cottbus, , Germany
Dresden, , Germany
Erlangen, , Germany
Hamburg, , Germany
Hannover, , Germany
Planegg, , Germany
Debrecen, Hajdu Bihar, Hungary
Veszprém, Veszprem, Hungary
Kormend, Zala, Hungary
Budapest, , Hungary
Gyula, , Hungary
Heviz, , Hungary
Kistarcsa, , Hungary
Szekesfehervar, , Hungary
Ramat Gan, Tel Aviv, Israel
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, , Israel
Kfar Saba, , Israel
Nagoya Shi, Aichi, Japan
Matsuyama Shi, Ehime, Japan
Asahikawa Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Kobe Shi, Hyogo, Japan
Nishinomiya Shi, Hyogo, Japan
Ono Shi, Hyogo, Japan
Kuwana Shi, Mie, Japan
Nagasaki Shi, Nagasaki, Japan
Sasebo Shi, Nagasaki, Japan
Okayama Shi, Okayama, Japan
Uruma Shi, Okinawa, Japan
Kawachinagano Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Suwon, Gyeonggido, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Mexico City, Ciudad De Mexico, Mexico
Papatoetoe, Auckland, New Zealand
Hamilton, Waikato, New Zealand
Wroclaw, Dolnoslaskie, Poland
Torun, Kujawsko Pomorskie, Poland
Lublin, Lubelskie, Poland
Bialystok, Podlaskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Poznan, Wielkopolskie, Poland
Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Kaliningrad, Kaliningradskaya Oblast, Russian Federation
Korolev, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Novosibirsk, Novosibirskaya Oblast, Russian Federation
St. Petersburg, Sankt Peterburg, Russian Federation
Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Izhevsk, Udmurtskaya Respublika, Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Omsk, , Russian Federation
Orenburg, , Russian Federation
Ryazan, , Russian Federation
Saratov, , Russian Federation
St. Petersburg, , Russian Federation
Ulyanovsk, , Russian Federation
Bratislava, , Slovakia
Nove Mesto Nad Vahom, , Slovakia
Piestany, , Slovakia
Poprad, , Slovakia
Zvolen, , Slovakia
Villajoyosa, Alicante, Spain
Sabadell, Barcelona, Spain
Santander, Cantabria, Spain
Vigo, Pontevedra, Spain
Cordoba, , Spain
Madrid, , Spain
Valencia, , Spain
Kaohsiung, Taichung, Taiwan
New Taipei City, , Taiwan
Taichung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Sihhiye, Ankara, Turkey
Cerrahpasa, , Turkey
Mugla, , Turkey
Kharkiv, Kharkivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Chernihiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Khmelnytskyi, , Ukraine
Kryvyi Rih, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Ternopil, , Ukraine
Vinnytsia, , Ukraine
Norwich, Norfolk, United Kingdom
Bury St Edmunds, Suffolk, United Kingdom
Armthorpe Road, , United Kingdom
Preston, , United Kingdom
Huntington Beach, California, United States
Worcester, Massachusetts, United States
Springfield, Missouri, United States
College Station, Texas, United States
Fort Worth, Texas, United States
San Miguel De Tucuman, Tucuman, Argentina
Suzhou, Jiangsu, China
Shanghai, Shanghai, China
Toulouse, Occitanie, France
Veszprém, Veszprem, Hungary
Kormend, Zala, Hungary
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Vinnytsia, , Ukraine
Preston, Lancashire, United Kingdom
Bury St Edmunds, Suffolk, United Kingdom
Armthorpe Road, , United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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