Evaluation of upadacitinib in adult subjects with axial spondyloarthritis

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003229-12-SK

Enrollment

690

Registered

2019-11-15

Start date

2020-01-14

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis MedDRA version: 21.1 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395

Interventions

Trade Name: Rinvoq Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: UPADACITINIB CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • adult females and males who are at least 18 years of age • clinical diagnosis of AS who meet the modified New York Criteria for AS (Study 1); OR • clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on MRI of sacroiliac joints or based on high sensitivity CRP > ULN (Study 2). • must have a BASDAI score = 4 and a Patient's Assessment of Total Back Pain score = 4 based on a 0 – 10 numerical rating scale at the Screening and Baseline Visits. • For Study 1, subjects must have exposed to 1 or 2 bDMARD (atleast 1 tumor necrosis factor (TNF) inhibitor or 1 interleukin [IL]-17 inhibitor) and subject must have discontinued 1 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). • For Study 2, prior treatment with at most 1 bDMARD (either 1 TNF inhibitor or 1 IL-17 inhibitor) is allowed in at least 20%, but not exceeding 35% of subjects) Remission-Withdrawal Period Specific Criteria: • Subject must be on study drug upon completion of the Open-Label Extension Period of Study 1 or Study 2 through Week 104. • Subject must achieve ASDAS (CRP) =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • Subject must not have total spinal ankylosis • Subjects who have had an inadequate response to both a TNF inhibitor and IL-17 inhibitor are not eligible.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult subjects with active axSpA including AS who had an inadequate response to a biologic disease-modifying antirheumatic drug (bDMARD) therapy (Study 1) and nr axSpA (Study 2); • To assess the safety and tolerability of upadacitinib in subjects with active axSpA including bDMARD-IR AS (Study 1) and with nr axSpA (Study 2). ;Secondary Objective: • To evaluate the safety and tolerability of upadacitinib in extended treatment in adult subjects with active axSpA including bDMARD-IR AS who have completed the Double Blind Period (Study 1) and with nr-axSpA who have completed the Double Blind Period (Study 2). • To evaluate the maintenance of disease control after withdrawal of upadacitinib in those who achieved ASDAS < 1.3 at Week 104 and ASDAS < 2.1 at Week 88.;Primary end point(s): Study 1 - Primary endpoint is ASAS 40 response at week 14 Study 2 - Primary endpoint is ASAS 40 response at week 14;Timepoint(s) of evaluation of this end point: Study 1 - Week 14 Study 2 - Week 14 (EU/EMA regulatory purposes); Week 52 (US/FDA regulatory purposes).	—

Measure

Time frame

Main Objective: • To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult subjects with active axSpA including AS who had an inadequate response to a biologic disease-modifying antirheumatic drug (bDMARD) therapy (Study 1) and nr axSpA (Study 2); • To assess the safety and tolerability of upadacitinib in subjects with active axSpA including bDMARD-IR AS (Study 1) and with nr axSpA (Study 2). ;Secondary Objective: • To evaluate the safety and tolerability of upadacitinib in extended treatment in adult subjects with active axSpA including bDMARD-IR AS who have completed the Double Blind Period (Study 1) and with nr-axSpA who have completed the Double Blind Period (Study 2). • To evaluate the maintenance of disease control after withdrawal of upadacitinib in those who achieved ASDAS < 1.3 at Week 104 and ASDAS < 2.1 at Week 88.;Primary end point(s): Study 1 - Primary endpoint is ASAS 40 response at week 14 Study 2 - Primary endpoint is ASAS 40 response at week 14;Timepoint(s) of evaluation of this end point: Study 1 - Week 14 Study 2 - Week 14 (EU/EMA regulatory purposes); Week 52 (US/FDA regulatory purposes).

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Secondary

Measure	Time frame
Secondary end point(s): Study 1: 1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); 2. Change from Baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine); 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response; 4. ASAS20 response 5. ASDAS Inactive Disease (ASDAS score < 1.3); 6. Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain); 7. Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain); 8. ASDAS Low Disease Activity (ASDAS score < 2.1); 9. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI); 10. ASAS partial remission (PR) (an absolute score of = 2 units for each of the 4 domains identified in ASAS 40); 11. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL); 12. Change from Baseline in ASAS Health Index (HI); 13. Change from Baseline in linear bath Ankylosing Spondylitis Metrology Index (BASMIlin). 14. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Study 2: 1. Change from Baseline in ASDAS; 2. Change from Baseline in MRI SPARCC score (SI joints); 3. BASDAI 50 response; 4. ASDAS Inactive Disease (ASDAS score < 1.3); 5. Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain); 6. Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain); 7. ASDAS Low Disease Activity (ASDAS score < 2.1); 8. ASAS PR (an absolute score of = 2 units for each of the 4 domains identified in ASAS40); 9. Change from Baseline in BASFI; 10. Change from Baseline in ASQoL 11. Change from Baseline in ASAS HI. 12. ASAS20 response; 13. Change from Baseline in BASMIlin. 14. Change from Baseline in MASES. 15. ASAS40 response at Week 52 (for European Union [EU]/European Medicines Agency [EMA] regulatory purposes).;Timepoint(s) of evaluation of this end point: Study 1 - Week 14 Study 2 - W	—

Measure

Time frame

Secondary end point(s): Study 1: 1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); 2. Change from Baseline in magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine); 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response; 4. ASAS20 response 5. ASDAS Inactive Disease (ASDAS score < 1.3); 6. Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain); 7. Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain); 8. ASDAS Low Disease Activity (ASDAS score < 2.1); 9. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI); 10. ASAS partial remission (PR) (an absolute score of = 2 units for each of the 4 domains identified in ASAS 40); 11. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL); 12. Change from Baseline in ASAS Health Index (HI); 13. Change from Baseline in linear bath Ankylosing Spondylitis Metrology Index (BASMIlin). 14. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Study 2: 1. Change from Baseline in ASDAS; 2. Change from Baseline in MRI SPARCC score (SI joints); 3. BASDAI 50 response; 4. ASDAS Inactive Disease (ASDAS score < 1.3); 5. Change from Baseline in Patient's Assessment of Total Back Pain (Total Back Pain); 6. Change from Baseline in Patient's Assessment of Nocturnal Back Pain (Nocturnal Back Pain); 7. ASDAS Low Disease Activity (ASDAS score < 2.1); 8. ASAS PR (an absolute score of = 2 units for each of the 4 domains identified in ASAS40); 9. Change from Baseline in BASFI; 10. Change from Baseline in ASQoL 11. Change from Baseline in ASAS HI. 12. ASAS20 response; 13. Change from Baseline in BASMIlin. 14. Change from Baseline in MASES. 15. ASAS40 response at Week 52 (for European Union [EU]/European Medicines Agency [EMA] regulatory purposes).;Timepoint(s) of evaluation of this end point: Study 1 - Week 14 Study 2 - W

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Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Russian Federation, Slovakia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com00441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026