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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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).

Key facts

Study ID

NCT03675308

Run by

AbbVie

People needed

964

Starts

2019-03-25

Expected to finish

2026-09-28

Last updated by the study team

2025-08-05

Who can join

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

You may qualify if…

• 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.

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.
• Participant has previous treatment with biologic agent.

Where it is running

• Sun Valley Arthritis Center Ltd. /ID# 200270 — Peoria, Arizona, United States
• AZ Arthritis and Rheumotology Research, PLLC /ID# 209873 — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875 — Tucson, Arizona, United States
• Southern Arizona VA Health Care System /ID# 209247 — Tucson, Arizona, United States
• Arthritis and Rheumatism Associates /ID# 209882 — Jonesboro, Arkansas, United States
• Valerius Medical Group & Research Center /ID# 207428 — Los Alamitos, California, United States
• Rheumatology Center of San Diego /ID# 201642 — San Diego, California, United States
• Inland Rheum Clin Trials Inc. /ID# 201641 — Upland, California, United States
• Medvin Clinical Research /ID# 211127 — Whittier, California, United States
• New England Research Associates, LLC /ID# 207237 — Bridgeport, Connecticut, United States
• Danbury Clinical Research, LLC /ID# 209517 — Danbury, Connecticut, United States
• Arthritis & Osteoporosis Center /ID# 207236 — Hamden, Connecticut, United States
• Arthritis & Rheumatic Disease Specialties /ID# 210802 — Aventura, Florida, United States
• Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099 — Boca Raton, Florida, United States
• SIMED Health, LLC /ID# 207461 — Gainesville, Florida, United States
• Sweet Hope Research Specialty Inc /ID# 209393 — Hialeah, Florida, United States
• Jacksonville Center for Clinical Research /ID# 209876 — Jacksonville, Florida, United States
• Rheum Assoc of Central FL /ID# 201622 — Orlando, Florida, United States
• HMD Research LLC /ID# 208427 — Orlando, Florida, United States
• IRIS Research and Development, LLC /ID# 208955 — Plantation, Florida, United States
• ForCare Clinical Research /ID# 168034 — Tampa, Florida, United States
• Arthritis and Rheumatology /ID# 168046 — Atlanta, Georgia, United States
• Affinity Clinical Research /ID# 210816 — Oak Brook, Illinois, United States
• OrthoIllinois /ID# 205300 — Rockford, Illinois, United States
• Pinnacle Research Group /ID# 167955 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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