A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

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

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 (With the last dose being administered at Week 40). 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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Risankizumab

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology & Skin Cancer Centre /ID# 213888
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 213889
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc /ID# 213886
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology /ID# 213887
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691
  • Bochum, Germany, 44791
    • Klinikum Ruhr Univ Bochum /ID# 225473
  • Luebeck, Germany, 23538
    • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469
  • Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472
  • Memmingen, Germany, 87700
    • Beldio Research GmbH /ID# 225471
  • Munich, Germany, 81675
    • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 214228
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 215889
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center /ID# 214059
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 213813
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 213815
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 213812
• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745
  • Cagliari, Italy, 09124
    • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 214751
  • Napoli, Italy, 80138
    • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas /ID# 214749
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 214034
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar /ID# 214428
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 214341
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 214032
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 214031
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon /ID# 214033
• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital /ID# 213634
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 213630
  • Taipei City, Taiwan, 10449
    • MacKay Memorial Hospital /ID# 213845
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 213631
• United Kingdom
  • Dudley, United Kingdom, DY1 2HQ
    • Russells Hall Hospital, Dudley /ID# 213878
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust /ID# 213880
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877
  • Salford, United Kingdom, M6 8HD
    • Northern Care Alliance NHS Group /ID# 213873
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • Victoria Hospital /ID# 213881
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and MOHs /ID# 216001
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6404
      • Burke Pharmaceutical Research /ID# 225023
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials /ID# 225497
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Derma & Skin Cance /ID# 213480
    • Sacramento, California, United States, 95816-3300
      • UC Davis Health /ID# 225367
  • Connecticut
    • Cromwell, Connecticut, United States, 06416-1745
      • CCD Research, PLLC /ID# 216062
  • Florida
    • Miami, Florida, United States, 33173
      • Florida International Rsrch cr /ID# 224983
  • Georgia
    • Sandy Springs, Georgia, United States, 30328-6141
      • Advanced Medical Research /ID# 213484
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 216000
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 216004
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates-Rockville /ID# 213837
  • Missouri
    • Kirksville, Missouri, United States, 63501-5362
      • Cleaver Dermatology /ID# 226137
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC /ID# 213479
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center /ID# 214795
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 225644
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC /ID# 213836
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc /ID# 215526
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology /ID# 225486
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PL /ID# 213835
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Res Inst /ID# 214002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Risankizumab; Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab	Drug: Risankizumab; Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).; Other Names: SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	At Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	At Week 16
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0	The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).	At Week 16
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1	The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.	At Week 16
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	At Week 52
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	At Week 52
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1	The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.	At Week 52
Proportion of Participants Achieving a PSS 0	The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).	At Week 52
Time to Achieve sPGA 0/1	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	Up to Week 52
Time to Achieve sPGA 0	The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.	Up to Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M19-164; 2019-000904-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No