A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.
This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.
Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional Extension.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Trialsites@msd.com1-888-577-8839
Chandler, Arizona 85225, United States
480-443-8400
Flagstaff, Arizona 86001, United States
Gilbert, Arizona 85297, United States
Glendale, Arizona 85306, United States
Tucson, Arizona 85704-1140, United States
Chula Vista, California 91910, United States
Huntington Beach, California 92648, United States
Upland, California 91786, United States
Aventura, Florida 33180, United States
Chicago, Illinois 60661, United States
Willowbrook, Illinois 60527, United States
Rockville, Maryland 20850, United States
St Louis, Missouri 63131, United States
Lincoln, Nebraska 68516-5497, United States
Duncansville, Pennsylvania 16635, United States
Philadelphia, Pennsylvania 19104, United States
Murfreesboro, Tennessee 37128, United States
Fort Worth, Texas 76109, United States
Irving, Texas 75039, United States
Curitiba, Paraná 80060-900, Brazil
Rio de Janeiro, 20241-180, Brazil
São Paulo, 05403-000, Brazil
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Trois-Rivières, Quebec G9A 3Y2, Canada
Bengbu, Anhui 233004, China
Beijing, Beijing Municipality 100005, China
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Luoyang, Henan 471003, China
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Lublin, Lublin Voivodeship 20-607, Poland
Warsaw, Masovian Voivodeship 02-637, Poland
New Taipei City, New Taipei 235, Taiwan
Taipei City, Taipei 100, Taiwan
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Istanbul, 34899, Turkey (Türkiye)
Cherkasy, Chernivetska Oblast 18009, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Khmelnytskiy, Khmelnytskyi Oblast 29000, Ukraine
+380501664721
Kyiv, Kyivska Oblast 04050, Ukraine
Lviv, Lviv Oblast 79011, Ukraine
Ternopil, Ternopil Oblast 46002, Ukraine
Vinnytsa, Vinnytsia Oblast 21018, Ukraine
+380674949895
Kyiv, 03049, Ukraine
Kyiv, 03057, Ukraine
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Bath, Somerset BA1 3NG, United Kingdom
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