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

Axial Spondyloarthritis

Study 1 - Primary endpoint is ASAS 40 response at week 14, Study 2 - Primary endpoint is ASAS 40 response at week 14

Study 1: Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS), Study 1: Change from Baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine), Study 1: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response, Study 1: ASAS20 response, Study 1: ASDAS Inactive Disease (ASDAS score < 1.3), Study 1: Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain), Study 1: Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain), Study 1: ASDAS Low Disease Activity (ASDAS score < 2.1), Study 1: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Study 1: ASAS partial remission (PR) (an absolute score of ≤ 2 units for each of the 4 domains identified in ASAS 40), Study 1: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL), Study 1: Change from Baseline in ASAS Health Index (HI), Study 1: Change from Baseline in linear bath Ankylosing Spondylitis Metrology Index (BASMIlin)., Study 1: Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)., Study 2: Change from Baseline in ASDAS, Study 2: Change from Baseline in MRI SPARCC score (SI joints), Study 2: BASDAI 50 response, Study 2: ASDAS Inactive Disease (ASDAS score < 1.3), Study 2: Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain), Study 2: Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain), Study 2: ASDAS Low Disease Activity (ASDAS score < 2.1), Study 2: ASAS PR (an absolute score of ≤ 2 units for each of the 4 domains identified in ASAS40), Study 2: Change from Baseline in BASFI, Study 2: Change from Baseline in ASQoL, Study 2: Change from Baseline in ASAS HI, Study 2: ASAS20 response, Study 2: Change from Baseline in BASMIlin, Study 2: Change from Baseline in MASES, Study 2: ASAS40 response at Week 52

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