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

Last updated: November 3, 2023
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Rash

Rosacea

Skin Wounds

Treatment

Risankizumab

Clinical Study ID

NCT04102007
M19-164
2019-000904-14
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 monthsbefore 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 Baselinevisits.
  • Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician GlobalAssessment (sPGA) 2/3
  • Participant must be eligible for continued biologic therapy as assessed by theinvestigator.

Exclusion

Exclusion Criteria:

  • History of erythrodermic psoriasis, generalized or localized pustular psoriasis,medication-induced or medication-exacerbated psoriasis, or new onset guttatepsoriasis, psoriatic arthritis.
  • Participant with active skin disease other than plaque psoriasis that could interferewith the assessment of plaque psoriasis.
  • History of any documented active or suspected malignancy or history of any malignancywithin 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 performedduring the conduct of the trial as assessed by the investigator.
  • Participant with exposure to risankizumab or any IL-23 inhibitors.

Study Design

Total Participants: 244
Treatment Group(s): 1
Primary Treatment: Risankizumab
Phase: 3
Study Start date:
November 12, 2019
Estimated Completion Date:
November 07, 2022

Connect with a study center

  • St George Dermatology & Skin Cancer Centre /ID# 213888

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Veracity Clinical Research /ID# 213889

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Skin Health Institute Inc /ID# 213886

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Fremantle Dermatology /ID# 213887

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • CHU d'Angers /ID# 214430

    Angers, 49933
    France

    Site Not Available

  • Hopital Saint Joseph /ID# 214429

    Marseille, 13008
    France

    Site Not Available

  • Chr Metz Thionville /Id# 214432

    Metz, 57085
    France

    Site Not Available

  • Hopital Begin /ID# 214431

    Saint Mande, 94160
    France

    Site Not Available

  • Hopital Nord /ID# 214618

    Saint Priest En Jarez, 42270
    France

    Site Not Available

  • Universitaetsklinikum Erlangen /ID# 214228

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt /ID# 215889

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt /ID# 215889

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 214469

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 215691

    Berlin, 10117
    Germany

    Site Not Available

  • Klinikum Ruhr Univ Bochum /ID# 225473

    Bochum, 44791
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 214469

    Luebeck, 23538
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 225472

    Mahlow, 15831
    Germany

    Site Not Available

  • Beldio Research GmbH /ID# 225471

    Memmingen, 87700
    Germany

    Site Not Available

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214506

    Munich, 81675
    Germany

    Site Not Available

  • Rabin Medical Center /ID# 213813

    Petach Tikva, Tel-Aviv 4941492
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 213815

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 213812

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • HaEmek Medical Center /ID# 214059

    Afula, 1834111
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 213813

    Petakh Tikva, 4941492
    Israel

    Site Not Available

  • Ichilov Medical Center /ID# 213812

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Istituto Clinico Humanitas /ID# 214749

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 214745

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 214748

    Cagliari, 09124
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750

    Milan, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena /ID# 214751

    Modena, 41124
    Italy

    Site Not Available

  • Universita di Napoli Federico II /ID# 214752

    Naples, 80131
    Italy

    Site Not Available

  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 214752

    Napoli, 80138
    Italy

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol /ID# 214031

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Alcorcon /ID# 214033

    Alcorcon, Madrid 28922
    Spain

    Site Not Available

  • Hospital Parc de Salut del Mar /ID# 214034

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Puerta del Mar /ID# 214428

    Cadiz, 11009
    Spain

    Site Not Available

  • Hospital Universitario La Paz /ID# 214341

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 214032

    Valencia, 46026
    Spain

    Site Not Available

  • Chung Shan Medical University Hospital /ID# 213634

    Taichung, 40201
    Taiwan

    Site Not Available

  • Chung Shan Medical University /ID# 213634

    Taichung City, 40201
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital /ID# 213845

    Taipei City, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital /ID# 213630

    Taipei City, 100
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 213631

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • NHS Fife /ID# 213881

    Dunfermline, Fife KY12 0SU
    United Kingdom

    Site Not Available

  • Victoria Hospital /ID# 213881

    Kirkcaldy, Fife KY2 5AH
    United Kingdom

    Site Not Available

  • Russells Hall Hospital, Dudley /ID# 213878

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust /ID# 213880

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 213877

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Northern Care Alliance NHS Group /ID# 213873

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Alliance Dermatology and MOHs /ID# 216001

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Burke Pharmaceutical Research /ID# 225023

    Hot Springs, Arkansas 71913-6404
    United States

    Site Not Available

  • Arkansas Research Trials /ID# 225497

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Bakersfield Derma & Skin Cance /ID# 213480

    Bakersfield, California 93309
    United States

    Site Not Available

  • UC Davis Health /ID# 225367

    Sacramento, California 95816-3300
    United States

    Site Not Available

  • CCD Research, PLLC /ID# 216062

    Cromwell, Connecticut 06416-1745
    United States

    Site Not Available

  • Florida International Rsrch cr /ID# 224983

    Miami, Florida 33173
    United States

    Site Not Available

  • Advanced Medical Research /ID# 213484

    Sandy Springs, Georgia 30328-6141
    United States

    Site Not Available

  • Arlington Dermatology /ID# 216000

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Dawes Fretzin, LLC /ID# 216004

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • DermAssociates-Rockville /ID# 213837

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Cleaver Dermatology /ID# 226137

    Kirksville, Missouri 63501-5362
    United States

    Site Not Available

  • Central Dermatology, PC /ID# 213479

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • University Hospitals Case Medical Center /ID# 214795

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University of Pittsburgh MC /ID# 225644

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Clinical Partners, LLC /ID# 213836

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Arlington Research Center, Inc /ID# 215526

    Arlington, Texas 76011
    United States

    Site Not Available

  • Bellaire Dermatology /ID# 225486

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Menter Dermatology Res Inst /ID# 214002

    Dallas, Texas 75246
    United States

    Site Not Available

  • Modern Research Associates, PL /ID# 213835

    Dallas, Texas 75231
    United States

    Site Not Available

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