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 USA 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

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)

Facility	City	Region
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

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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 the USA