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Clinical Trials List

Protocol NumberM16-011
NCT Number(ClinicalTrials.gov Identfier)NCT03675308
Active

2018-12-20 - 2027-01-30

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(KEEPsAKE 1)

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 賴寧生 Division of Rheumatology
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yu-Huei Huang Division of Dermatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗 風濕免疫科
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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

injection

Dosage

75mg

Endpoints

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 [ Time Frame: Baseline and 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).

Inclution Criteria

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

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

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