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Clinical Trials in South Korea / NCT03675308
Active, not recruiting Phase 3

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

NCT03675308 · tracked via the Priya Life Science South Korea tracker
Sponsor
AbbVie
Phase
Phase 3
Started
2019-03-25
Last updated
2025-08-05

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

PlaceboRisankizumab →

Placebo: Placebo for risankizumab administered by subcutaneous injection

Risankizumab: Risankizumab administered by subcutaneous injection

Study summary

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit. * Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) * Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit. * Participant has demonstrated an inadequate response or intolerance to or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies). * Presence of either at Screening: * ≥ 1 erosion on radiograph as determined by central imaging review or; * High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L. Exclusion Criteria: * Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study. * Participant has a known hypersensitivity to risankizumab. * Participant has previous treatment with biologic agent.

Primary outcome measure(s)

  • Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 — Baseline and Week 24
    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

Trial sites (256)

FacilityCityRegionStatus
Pinnacle Research Group /ID# 167955 Anniston Alabama
Sun Valley Arthritis Center Ltd. /ID# 200270 Peoria Arizona
AZ Arthritis and Rheumotology Research, PLLC /ID# 209873 Phoenix Arizona
Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875 Tucson Arizona
Southern Arizona VA Health Care System /ID# 209247 Tucson Arizona
Arthritis and Rheumatism Associates /ID# 209882 Jonesboro Arkansas
Valerius Medical Group & Research Center /ID# 207428 Los Alamitos California
Rheumatology Center of San Diego /ID# 201642 San Diego California
Inland Rheum Clin Trials Inc. /ID# 201641 Upland California
Medvin Clinical Research /ID# 211127 Whittier California
New England Research Associates, LLC /ID# 207237 Bridgeport Connecticut
Danbury Clinical Research, LLC /ID# 209517 Danbury Connecticut
Arthritis & Osteoporosis Center /ID# 207236 Hamden Connecticut
Arthritis & Rheumatic Disease Specialties /ID# 210802 Aventura Florida
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099 Boca Raton Florida
SIMED Health, LLC /ID# 207461 Gainesville Florida
Sweet Hope Research Specialty Inc /ID# 209393 Hialeah Florida
Jacksonville Center for Clinical Research /ID# 209876 Jacksonville Florida
Rheum Assoc of Central FL /ID# 201622 Orlando Florida
HMD Research LLC /ID# 208427 Orlando Florida
IRIS Research and Development, LLC /ID# 208955 Plantation Florida
ForCare Clinical Research /ID# 168034 Tampa Florida
Arthritis and Rheumatology /ID# 168046 Atlanta Georgia
Affinity Clinical Research /ID# 210816 Oak Brook Illinois
OrthoIllinois /ID# 205300 Rockford Illinois
Springfield Clinic /ID# 200244 Springfield Illinois
Klein and Associates MD /ID# 169483 Hagerstown Maryland
The Center for Rheumatology and Bone Research /ID# 168017 Wheaton Maryland
Clinical Pharmacology Study Gr /ID# 168019 Worcester Massachusetts
Advanced Rheumatology, PC /ID# 168042 Lansing Michigan
June DO, PC /ID# 208915 Lansing Michigan
St. Paul Rheumatology /ID# 208471 Eagan Minnesota
Logan Health Research /ID# 213707 Kalispell Montana
Physician Research Collaboration, LLC /ID# 208670 Lincoln Nebraska
Center for Rheumatology LLP /ID# 207313 Albany New York
NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310 Brooklyn New York
Joint & Muscle Research Instit /ID# 208620 Charlotte North Carolina
Medication Management, LLC /ID# 211734 Greensboro North Carolina
Coastal Carolina Health Care /ID# 208619 New Bern North Carolina
Velocity Clinical Research /ID# 200452 Blue Ash Ohio

+ 216 more sites — see the full list on the official registry below.

On this site

📄 Skyrizi (risankizumab) drug profile →

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Other trials for the same condition

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis Active, not recruiting
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines Recruiting
Korean College of Rheumatology Biologics and Targeted Therapy Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03675308 on ClinicalTrials.gov ↗ ← All trials in South Korea