A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis (PsA)

In brief

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Key facts

Study ID

NCT03671148

Run by

AbbVie

People needed

444

Starts

2019-03-07

Expected to finish

2026-06-04

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
• Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
• 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 biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

You may not qualify if…

• Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
• Participant has a known hypersensitivity to risankizumab.

Where it is running

• St. Jude Heritage /ID# 166842 — Fullerton, California, United States
• Newport Huntington Medica /ID# 207423 — Huntington Beach, California, United States
• Arthritis & Osteo Medical Ctr /ID# 166541 — La Palma, California, United States
• East Bay Rheumatology Medical /ID# 166845 — San Leandro, California, United States
• Inland Rheum Clin Trials Inc. /ID# 166621 — Upland, California, United States
• Denver Arthritis Clinic /ID# 166442 — Denver, Colorado, United States
• New England Research Associates, LLC /ID# 166525 — Bridgeport, Connecticut, United States
• Yale University /ID# 166330 — New Haven, Connecticut, United States
• Arthritis & Rheumatic Disease Specialties /ID# 212582 — Aventura, Florida, United States
• SIMED Health, LLC /ID# 207457 — Gainesville, Florida, United States
• Sweet Hope Research Specialty Inc /ID# 168163 — Hialeah, Florida, United States
• Rheum Assoc of Central FL /ID# 201629 — Orlando, Florida, United States
• HMD Research LLC /ID# 208428 — Orlando, Florida, United States
• Millennium Research /ID# 201627 — Ormond Beach, Florida, United States
• Arthritis Center, Inc. /ID# 208116 — Palm Harbor, Florida, United States
• IRIS Research and Development, LLC /ID# 166351 — Plantation, Florida, United States
• BayCare Medical Group /ID# 201630 — St. Petersburg, Florida, United States
• West Broward Rheumatology Associates /ID# 201234 — Tamarac, Florida, United States
• University of South Florida /ID# 208467 — Tampa, Florida, United States
• ForCare Clinical Research /ID# 166375 — Tampa, Florida, United States
• Arthritis and Rheumatology /ID# 169438 — Atlanta, Georgia, United States
• Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681 — Skokie, Illinois, United States
• Springfield Clinic /ID# 166345 — Springfield, Illinois, United States
• Ochsner Clinic Foundation /ID# 166622 — Baton Rouge, Louisiana, United States
• Pinnacle Research Group /ID# 167953 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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