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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04102007
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Germany, Israel, Italy, Spain, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Other: Risankizumab

Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab

Interventions

Drug: - Risankizumab

Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bakersfield, California

Status

Recruiting

Address

Bakersfield Derma & Skin Cance /ID# 213480

Bakersfield, California, 93309

Cromwell, Connecticut

Status

Recruiting

Address

Central Connecticut Dermatology /ID# 216062

Cromwell, Connecticut, 06416-1745

Advanced Medical Research /ID# 213484, Sandy Springs, Georgia

Status

Recruiting

Address

Advanced Medical Research /ID# 213484

Sandy Springs, Georgia, 30328-6141

Arlington Dermatology /ID# 216000, Rolling Meadows, Illinois

Status

Recruiting

Address

Arlington Dermatology /ID# 216000

Rolling Meadows, Illinois, 60008

Dawes Fretzin, LLC /ID# 216004, Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin, LLC /ID# 216004

Indianapolis, Indiana, 46256

DermAssociates /ID# 213837, Rockville, Maryland

Status

Recruiting

Address

DermAssociates /ID# 213837

Rockville, Maryland, 20850

Central Dermatology, PC /ID# 213479, Saint Louis, Missouri

Status

Recruiting

Address

Central Dermatology, PC /ID# 213479

Saint Louis, Missouri, 63117

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Case Medical Center /ID# 214795

Cleveland, Ohio, 44106

Clinical Partners, LLC /ID# 213836, Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC /ID# 213836

Johnston, Rhode Island, 02919

Dallas, Texas

Status

Recruiting

Address

Modern Research Associates, PL /ID# 213835

Dallas, Texas, 75231

Menter Dermatology Res Inst /ID# 214002, Dallas, Texas

Status

Recruiting

Address

Menter Dermatology Res Inst /ID# 214002

Dallas, Texas, 75246

International Sites

Kogarah, New South Wales, Australia

Status

Recruiting

Address

St George Dermatology & Skin Cancer Centre /ID# 213888

Kogarah, New South Wales, 2217

Veracity Clinical Research /ID# 213889, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Veracity Clinical Research /ID# 213889

Woolloongabba, Queensland, 4102

Skin Health Institute Inc /ID# 213886, Carlton, Victoria, Australia

Status

Recruiting

Address

Skin Health Institute Inc /ID# 213886

Carlton, Victoria, 3053

Fremantle Dermatology /ID# 213887, Fremantle, Western Australia, Australia

Status

Recruiting

Address

Fremantle Dermatology /ID# 213887

Fremantle, Western Australia, 6160

Erlangen, Bayern, Germany

Status

Recruiting

Address

Universitaetsklinikum Erlangen /ID# 214228

Erlangen, Bayern, 91054

Frankfurt, Hessen, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt /ID# 215889

Frankfurt, Hessen, 60590

Berlin, Germany

Status

Recruiting

Address

Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 215691

Berlin, , 10117

Univ Hosp Schleswig-Holstein /ID# 214469, Kiel, Germany

Status

Recruiting

Address

Univ Hosp Schleswig-Holstein /ID# 214469

Kiel, , 24105

TU Uniklinik Munchen /ID# 214506, Munich, Germany

Status

Recruiting

Address

TU Uniklinik Munchen /ID# 214506

Munich, , 80802

Rabin Medical Center /ID# 213813, Petakh Tikva, Tel-Aviv, Israel

Status

Recruiting

Address

Rabin Medical Center /ID# 213813

Petakh Tikva, Tel-Aviv, 4941492

Ha'Emek Medical Center /ID# 214059, Afula, Israel

Status

Recruiting

Address

Ha'Emek Medical Center /ID# 214059

Afula, , 18341

Sheba Medical Center /ID# 213815, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center /ID# 213815

Ramat Gan, , 5239424

Ichilov Medical Center /ID# 213812, Tel Aviv, Israel

Status

Recruiting

Address

Ichilov Medical Center /ID# 213812

Tel Aviv, , 64239

Napoli, Campania, Italy

Status

Not yet recruiting

Address

Universita della Campania Luigi Vanvitelli /ID# 214752

Napoli, Campania, 80131

Milan, Lombardia, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214750

Milan, Lombardia, 20122

Rozzano, Milano, Italy

Status

Recruiting

Address

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 214749

Rozzano, Milano, 20089

Bologna, Italy

Status

Recruiting

Address

A.O. Policlinico Sant'Orsola Malpighi /ID# 214745

Bologna, , 40138

Ospedale San Giovanni di Dio /ID# 214748, Cagliari, Italy

Status

Recruiting

Address

Ospedale San Giovanni di Dio /ID# 214748

Cagliari, , 9124

AO Univ di Modena /ID# 214751, Modena, Italy

Status

Recruiting

Address

AO Univ di Modena /ID# 214751

Modena, , 41100

Badalona, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Germans Trias i Pujol /ID# 214031

Badalona, Barcelona, 08916

Alcorcon, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Alcorcon /ID# 214033

Alcorcon, , 28922

Barcelona, Spain

Status

Recruiting

Address

Hospital Parc de Salut del Mar /ID# 214034

Barcelona, , 08003

Hospital Puerta del Mar /ID# 214428, Cadiz, Spain

Status

Recruiting

Address

Hospital Puerta del Mar /ID# 214428

Cadiz, , 11009

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz /ID# 214341

Madrid, , 28046

Valencia, Spain

Status

Recruiting

Address

Hospital Universitario y Politecnico La Fe /ID# 214032

Valencia, , 46026

National Taiwan Univ Hosp /ID# 213630, Taipei City, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan Univ Hosp /ID# 213630

Taipei City, Taipei, 10002

Taichung City, Taiwan

Status

Recruiting

Address

Chung Shan Medical University /ID# 213634

Taichung City, , 40201

MacKay Memorial Hospital /ID# 213845, Taipei City, Taiwan

Status

Recruiting

Address

MacKay Memorial Hospital /ID# 213845

Taipei City, , 10449

Taoyuan City, Taiwan

Status

Recruiting

Address

Linkou Chang Gung Memorial Ho /ID# 213631

Taoyuan City, , 33305

NHS Fife /ID# 213881, Dunfermline, Fife, United Kingdom

Status

Recruiting

Address

NHS Fife /ID# 213881

Dunfermline, Fife, KY12 0SU

Dudley, United Kingdom

Status

Recruiting

Address

Russells Hall Hospital, Dudley /ID# 213878

Dudley, , DY1 2HQ

Chapel Allerton Hospital /ID# 213880, Leeds, United Kingdom

Status

Recruiting

Address

Chapel Allerton Hospital /ID# 213880

Leeds, , LS7 4SA

Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Newcastle upon Tyne Hospitals /ID# 213877

Newcastle Upon Tyne, , NE7 7DN

The University of Manchester /ID# 213873, Salford, United Kingdom

Status

Recruiting

Address

The University of Manchester /ID# 213873

Salford, , M6 8HD

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