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Clinical Trials List

Protocol NumberM19-164

NCT Number(ClinicalTrials.gov Identfier)NCT04102007

2019-12-01 - 2022-12-31

Phase IV

Recruiting4

ICD-10 L40.9

Psoriasis, unspecified

A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab

Trial Applicant

AbbVie
Sponsor

AbbVie
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Yu-Huei Huang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Ya-Ching Chang 無
Chung-Yao Hsu 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴柏如無

Chung Shan Medical University Hospital

Co-Principal Investigator

王鼎舜無
洪琡茹無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖無

MacKay Memorial Hospital

Co-Principal Investigator

王仁佑無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSEN-FANG TSAI 無

National Taiwan University Hospital

Co-Principal Investigator

Chih-Chieh Chan 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Moderate to Severe Plaque Psoriasis

Objectives

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks. An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

Test Drug

Risankizumab
Risankizumab

Active Ingredient

Pre-filled syringe
Pre-filled syringe

Dosage Form

Pre-filled syringe
Pre-filled syringe

Dosage

75
75

Endpoints

Primary Outcome Measures :

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 [ Time Frame: At Week 16 ]
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

Inclution Criteria

Inclusion Criteria:

Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
Participant must be eligible for continued biologic therapy as assessed by the investigator.

Exclusion Criteria

Exclusion Criteria:

History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
Participant with exposure to risankizumab or any IL-23 inhibitors.
No known active SARS-CoV-2 infection.

The Estimated Number of Participants

Taiwan

40 participants
Global

250 participants