A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004130-24-CZ

Enrollment

1705

Registered

2017-07-07

Start date

2017-08-15

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Moderately to Severely Active Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, at least 18 years of age 2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) 3. Subject has active disease at Baseline defined as = 3 tender joints (based on 68 joint counts) and = 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits 4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis 5. Subject is on current treatment with = 2 nonbiologic DMARDs 6. Subject has had an inadequate response to previous or current treatment with at least 1 non-biologic DMARD (MTX, SSZ, LEF, cyclosporine, apremilast, bucillamine, or iguratimod), or subject has an intolerance to or contraindication for DMARDs 7. Presence of either at Screening: • = 1 erosion on x-ray • hs-CRP > laboratory-defined upper limit of normal (ULN) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1468 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 237

Exclusion criteria

Exclusion criteria: 1. Prior exposure to any Janus Kinase (JAK) inhibitor 2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective 1. To compare the efficacy of upadacitinib 15 mg QD and 30 mg QD versus placebo and versus adalimumab (ADA) for the treatment of signs and symptoms of PsA in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR). Secondary Objective 2. To compare the efficacy of upadacitinib 15 mg QD and 30 mg QD versus placebo for the prevention of structural progression in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR). 3. To compare the safety and tolerability of upadacitinib 15 mg QD and 30 mg QD versus placebo and versus adalimumab in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR).;Secondary Objective: To evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who have completed Period 1.;Primary end point(s): The proportion of subjects achieving ACR20 response;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: Primary Objective 1. To compare the efficacy of upadacitinib 15 mg QD and 30 mg QD versus placebo and versus adalimumab (ADA) for the treatment of signs and symptoms of PsA in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR). Secondary Objective 2. To compare the efficacy of upadacitinib 15 mg QD and 30 mg QD versus placebo for the prevention of structural progression in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR). 3. To compare the safety and tolerability of upadacitinib 15 mg QD and 30 mg QD versus placebo and versus adalimumab in subjects with moderately to severely active PsA who have an inadequate response or intolerance to 1 or more non-biologic DMARD (DMARD-IR).;Secondary Objective: To evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who have completed Period 1.;Primary end point(s): The proportion of subjects achieving ACR20 response;Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in HAQ-DI 2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline 3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with = 3% BSA psoriasis at baseline) 4. Change from baseline in modified PsA Sharp/van der Heijde Score (SHS) 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Proportion of subjects with resolution of enthesitis (LEI = 0) 7. ACR 20 response rate (non-inferiority of upadacitinib vs adalimumab); 8. Change from baseline in SF-36 PCS 9. Change from baseline in FACIT-Fatigue Questionnaire at Week 12; 10. ACR 20 response rate (superiority of upadacitinib vs adalimumab); 11. Proportion of subjects with resolution of dactylitis (LDI = 0) 12. Change from baseline in Patient's Assessment of Pain NRS (superiority of upadacitinib vs. adalimumab); 13. Change from baseline in HAQ-DI (superiority of upadacitinib vs. adalimumab); 14. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 15. ACR 50/70 response rate 16. ACR 20 response rate ;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 16 3. Week 16 4. Week 24 5. Week 24 6. Week 24 7. Week 12 8. Week 12 9. Week 12 10. Week 12 11. Week 24 12. Week 12 13. Week 12 14. Week 16 15. Week 12 16. Week 2	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline in HAQ-DI 2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline 3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with = 3% BSA psoriasis at baseline) 4. Change from baseline in modified PsA Sharp/van der Heijde Score (SHS) 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Proportion of subjects with resolution of enthesitis (LEI = 0) 7. ACR 20 response rate (non-inferiority of upadacitinib vs adalimumab); 8. Change from baseline in SF-36 PCS 9. Change from baseline in FACIT-Fatigue Questionnaire at Week 12; 10. ACR 20 response rate (superiority of upadacitinib vs adalimumab); 11. Proportion of subjects with resolution of dactylitis (LDI = 0) 12. Change from baseline in Patient's Assessment of Pain NRS (superiority of upadacitinib vs. adalimumab); 13. Change from baseline in HAQ-DI (superiority of upadacitinib vs. adalimumab); 14. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 15. ACR 50/70 response rate 16. ACR 20 response rate ;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 16 3. Week 16 4. Week 24 5. Week 24 6. Week 24 7. Week 12 8. Week 12 9. Week 12 10. Week 12 11. Week 24 12. Week 12 13. Week 12 14. Week 16 15. Week 12 16. Week 2

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Countries

Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Greece, Hong Kong, Hungary, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Portugal, Puerto Rico, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com441628561090

Outcome results

None listed

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