Clinical Trials in the UK / NCT03671148
Active, not recruiting
Phase 3
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)
NCT03671148 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Psoriatic Arthritis (PsA)
Investigational drug(s) / intervention(s)
PlaceboRisankizumab →
Placebo: Placebo for risankizumab administered by subcutaneous (SC) injection
Risankizumab: Risankizumab administered by subcutaneous (SC) injection
Study summary
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
Eligibility
Inclusion Criteria:
* 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).
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.
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 (138)
| Facility | City | Region | Status |
|---|---|---|---|
| Pinnacle Research Group /ID# 167953 | Anniston | Alabama | |
| St. Jude Heritage /ID# 166842 | Fullerton | California | |
| Newport Huntington Medica /ID# 207423 | Huntington Beach | California | |
| Arthritis & Osteo Medical Ctr /ID# 166541 | La Palma | California | |
| East Bay Rheumatology Medical /ID# 166845 | San Leandro | California | |
| Inland Rheum Clin Trials Inc. /ID# 166621 | Upland | California | |
| Denver Arthritis Clinic /ID# 166442 | Denver | Colorado | |
| New England Research Associates, LLC /ID# 166525 | Bridgeport | Connecticut | |
| Yale University /ID# 166330 | New Haven | Connecticut | |
| Arthritis & Rheumatic Disease Specialties /ID# 212582 | Aventura | Florida | |
| SIMED Health, LLC /ID# 207457 | Gainesville | Florida | |
| Sweet Hope Research Specialty Inc /ID# 168163 | Hialeah | Florida | |
| Rheum Assoc of Central FL /ID# 201629 | Orlando | Florida | |
| HMD Research LLC /ID# 208428 | Orlando | Florida | |
| Millennium Research /ID# 201627 | Ormond Beach | Florida | |
| Arthritis Center, Inc. /ID# 208116 | Palm Harbor | Florida | |
| IRIS Research and Development, LLC /ID# 166351 | Plantation | Florida | |
| BayCare Medical Group /ID# 201630 | St. Petersburg | Florida | |
| West Broward Rheumatology Associates /ID# 201234 | Tamarac | Florida | |
| University of South Florida /ID# 208467 | Tampa | Florida | |
| ForCare Clinical Research /ID# 166375 | Tampa | Florida | |
| Arthritis and Rheumatology /ID# 169438 | Atlanta | Georgia | |
| Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681 | Skokie | Illinois | |
| Springfield Clinic /ID# 166345 | Springfield | Illinois | |
| Ochsner Clinic Foundation /ID# 166622 | Baton Rouge | Louisiana | |
| The Arthritis & Diabetes Clinic, Inc. /ID# 166707 | Monroe | Louisiana | |
| MMP Women's Health /ID# 169334 | Portland | Maine | |
| Klein and Associates MD /ID# 166549 | Hagerstown | Maryland | |
| Duplicate_The Center for Rheumatology & Bone Research /ID# 166448 | Wheaton | Maryland | |
| Clinical Pharmacology Study Gr /ID# 166455 | Worcester | Massachusetts | |
| St. Paul Rheumatology /ID# 166599 | Eagan | Minnesota | |
| Clinvest Research LLC /ID# 166745 | Springfield | Missouri | |
| Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389 | St Louis | Missouri | |
| Glacier View Research Institute /ID# 169344 | Kalispell | Montana | |
| Dartmouth-Hitchcock Medical Center /ID# 169443 | Lebanon | New Hampshire | |
| Ocean Rheumatology, PA /ID# 166561 | Toms River | New Jersey | |
| Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658 | Voorhees Township | New Jersey | |
| Paramount Medical Research Con /ID# 166334 | Middleburg Heights | Ohio | |
| Health Research of Oklahoma /ID# 166408 | Oklahoma City | Oklahoma | |
| Altoona Ctr Clinical Res /ID# 166691 | Duncansville | Pennsylvania |
+ 98 more sites — see the full list on the official registry below.
On this site
📄 Skyrizi (risankizumab) drug profile →More AbbVie trials in the UK
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Active, not recruiting
Other trials for the same condition
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 NCT03671148 on ClinicalTrials.gov ↗ ← All trials in the UK