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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

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04102007
Collaborator
(none)
250
Enrollment
57
Locations
1
Arm
36.1
Anticipated Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 12, 2019
Actual Primary Completion Date :
Jan 17, 2022
Anticipated Study Completion Date :
Nov 16, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 [At Week 16]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving a sPGA Clear Response (sPGA 0) [At Week 16]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    2. Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) 0 or 1 [At Week 16]

      The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status.

    3. Percentage of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 [At Week 16]

      The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.

    4. Percentage of Participants Achieving sPGA 0/1 [At Week 52]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    5. Percentage of Participants Achieving a sPGA 0 [At Week 52]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    6. Percentage of Participants Achieving a DLQI 0/1 [At Week 52]

      The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status.

    7. Percentage of Participants Achieving a PSS 0 [At Week 52]

      The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.

    8. Time to Achieve sPGA 0/1 [Up to Week 52]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    9. Time to Achieve sPGA 0 [Up to Week 52]

      The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    • 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. -- At least 14 days since first PCR test result have passed in asymptomatic participants or 14 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04102007
    Other Study ID Numbers:
    • M19-164
    • 2019-000904-14
    First Posted:
    Sep 25, 2019
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Plaque Psoriasis
    Risankizumab
    Secukinumab
    Ixekizumab
    Psoriasis
    Biologic
    Skyrizi
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Mar 18, 2022