ABT-494 for Psoriatic Arthritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Psoriatic Arthritis+3 More
ABT-494 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of two doses of a new drug, upadacitinib, to a placebo and to the drug adalimumab, in people with psoriatic arthritis who have not responded well to other treatments. The trial will also look at the long-term safety and effectiveness of upadacitinib.

Eligible Conditions
  • Psoriatic Arthritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Psoriatic Arthritis

Study Objectives

2 Primary · 34 Secondary · Reporting Duration: Baseline (Day 1) to Week 24

Week 12
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire
Change in HAQ-DI
Change in HAQ-DI (Superiority of ABT-494 vs. Adalimumab)
Change in Patient's Assessment of Pain Numerical Rating Scale (NRS) (Superiority of ABT-494 vs. Adalimumab)
Change in Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
Week 16
Change in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire
Week 24
Change in Modified PsA Sharp/van der Heijde Score (SHS)
Baseline and Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
Rheumatoid Factor
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Baseline and Week 16
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Baseline and Week 2
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Baseline and Week 24
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24
Week 12
ACR 20 Response Rate (Non-Inferiority of ABT-494 vs Adalimumab)
ACR 20 Response Rate (Superiority of ABT-494 vs. Adalimumab)
ACR 50 Response
ACR 70 Response
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
Week 16
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point Improvement From Baseline
Psoriasis Area Severity Index (PASI) 75 Response (For Participants With >= 3% Body Surface Area (BSA) Psoriasis at Baseline)
Week 2
ACR 20 Response
Week 24
Percentage of Participants Achieving Minimal Disease Activity (MDA)
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Percentage of Participants With Resolution of Dactylitis (Leeds Dactylitis Index (LDI)=0)
Percentage of Participants With Resolution of Dactylitis at Week 24
Percentage of Participants With Resolution of Enthesitis (Leeds Enthesitis Index (LEI)=0)
Percentage of Participants With Resolution of Enthesitis at Week 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Psoriatic Arthritis

Trial Design

10 Treatment Groups

Adalimumab + Placebo ABT-494
1 of 10
Adalimumab
1 of 10
ABT-494 Dose B + Placebo Adalimumab
1 of 10
Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose A
1 of 10
Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose B
1 of 10
Upadacitinib 15 mg
1 of 10
Upadacitinib 30 mg
1 of 10
ABT-494 Dose A + Placebo Adalimumab
1 of 10
Placebo / Upadacitinib 15 mg
1 of 10
Placebo / Upadacitinib 30 mg
1 of 10
Active Control
Experimental Treatment
Non-Treatment Group

1705 Total Participants · 10 Treatment Groups

Primary Treatment: ABT-494 · Has Placebo Group · Phase 3

ABT-494 Dose B + Placebo AdalimumabExperimental Group · 2 Interventions: ABT-494, Placebo for Adalimumab · Intervention Types: Drug, Drug
Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose AExperimental Group · 3 Interventions: ABT-494, Placebo for ABT-494, Placebo for Adalimumab · Intervention Types: Drug, Drug, Drug
Placebo ABT-494 + Placebo Adalimumab Then ABT-494 Dose BExperimental Group · 3 Interventions: ABT-494, Placebo for ABT-494, Placebo for Adalimumab · Intervention Types: Drug, Drug, Drug
Upadacitinib 15 mgExperimental Group · 2 Interventions: Placebo to Adalimumab, Upadacitinib · Intervention Types: Drug, Drug
Upadacitinib 30 mgExperimental Group · 2 Interventions: Placebo to Adalimumab, Upadacitinib · Intervention Types: Drug, Drug
ABT-494 Dose A + Placebo AdalimumabExperimental Group · 2 Interventions: ABT-494, Placebo for Adalimumab · Intervention Types: Drug, Drug
Placebo / Upadacitinib 15 mgPlaceboComparator Group · 3 Interventions: Placebo to Adalimumab, Placebo to Upadacitinib, Upadacitinib · Intervention Types: Drug, Drug, Drug
Adalimumab + Placebo ABT-494ActiveComparator Group · 2 Interventions: Adalimumab, Placebo for ABT-494 · Intervention Types: Drug, Drug
AdalimumabActiveComparator Group · 2 Interventions: Adalimumab, Placebo to Upadacitinib · Intervention Types: Drug, Drug
Placebo / Upadacitinib 30 mgPlaceboComparator Group · 3 Interventions: Placebo to Adalimumab, Placebo to Upadacitinib, Upadacitinib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved
Placebo to Adalimumab
2010
Completed Phase 3
~120
Upadacitinib
2014
Completed Phase 3
~8080
Placebo for Adalimumab
2018
Completed Phase 3
~390

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) to week 24

Who is running the clinical trial?

AbbVieLead Sponsor
822 Previous Clinical Trials
467,900 Total Patients Enrolled
21 Trials studying Psoriatic Arthritis
106,368 Patients Enrolled for Psoriatic Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
99,390 Total Patients Enrolled
11 Trials studying Psoriatic Arthritis
12,365 Patients Enrolled for Psoriatic Arthritis

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A radiographic finding of erosion on a panoramic radiograph or dental radiograph.
You have active plaque psoriasis or documented history of plaque psoriasis.
You are 4 weeks or older.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References