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Clinical Trials List

Protocol NumberM16-011

NCT Number(ClinicalTrials.gov Identfier)NCT03675308

Active

2018-12-20 - 2030-01-31

Phase III

Terminated3

ICD-10L40.52

Psoriatic arthritis mutilans

ICD-9696.0

Psoriatic arthropathy

A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects 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

Trial Applicant

AbbVie
Sponsor

ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND)
Trial scale

Multi-Regional Multi-Center
Update

2026/09/18

Investigators and Locations

Principal Investigator 賴寧生無

Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗無

Chung Shan Medical University Hospital

Co-Principal Investigator

王世叡未分科
梁培英無
霍安平無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yu-Huei Huang

Linkou Chang Gung Medical Foundation

Taiwan National PI

黃毓惠

Co-Principal Investigator

Chung-Yao Hsu 未分科
Chang-Fu Kuo 未分科
陳彥輔未分科
Yao-Fan Fang

The Actual Total Number of Participants Enrolled

3 Stop recruiting

Audit

None

Condition/Disease

Psoriatic Arthritis

Objectives

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).

Test Drug

Risankizumab

Active Ingredient

Risankizumab

Dosage Form

N/A

Dosage

N/A

Endpoints

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 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).
Baseline and Week 24

Inclution 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.

The Estimated Number of Participants

Taiwan

12 participants
Global

880 participants