Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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 (aimm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102007
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Plaque Psoriasis Drug: Risankizumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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 : November 12, 2019
Estimated Primary Completion Date : December 13, 2020
Estimated Study Completion Date : November 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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 Name: SKYRIZI




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of participants achieving a sPGA clear response [ Time Frame: 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 Psoriasis Symptoms Scale (PSS) 0 [ Time Frame: At Week 16 ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.

  3. Time to achieve sPGA 0 [ Time Frame: Up to Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  4. Percentage of participants achieving a Dermatology Life Quality Index (DLQI) 0 or 1 [ Time Frame: 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.

  5. Percentage of participants achieving sPGA 0/1 [ Time Frame: 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 sPGA 0 [ Time Frame: At Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  7. Percentage of participants achieving a DLQI 0/1 [ Time Frame: 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.

  8. Percentage of participants achieving a PSS 0 [ Time Frame: At Week 52 ]
    The PSS is a four-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms.

  9. Time to achieve sPGA 0/1 [ Time Frame: Up to Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102007


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Hide Hide 50 study locations
Layout table for location information
United States, California
Bakersfield Derma & Skin Cance /ID# 213480 Recruiting
Bakersfield, California, United States, 93309
United States, Connecticut
Central Connecticut Dermatology /ID# 216062 Not yet recruiting
Cromwell, Connecticut, United States, 06416-1745
United States, Georgia
Advanced Medical Research /ID# 213484 Not yet recruiting
Sandy Springs, Georgia, United States, 30328-6141
United States, Illinois
Arlington Dermatology /ID# 216000 Recruiting
Rolling Meadows, Illinois, United States, 60008-3811
United States, Indiana
Dawes Fretzin, LLC /ID# 216004 Recruiting
Indianapolis, Indiana, United States, 46256
United States, Maryland
DermAssociates /ID# 213837 Recruiting
Rockville, Maryland, United States, 20850
United States, Missouri
Central Dermatology, PC /ID# 213479 Recruiting
Saint Louis, Missouri, United States, 63117
United States, Ohio
University Hospitals Case Medical Center /ID# 214795 Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Clinical Partners, LLC /ID# 213836 Recruiting
Johnston, Rhode Island, United States, 02919
United States, Texas
Modern Research Associates, PL /ID# 213835 Recruiting
Dallas, Texas, United States, 75231
Menter Dermatology Res Inst /ID# 214002 Not yet recruiting
Dallas, Texas, United States, 75246
Australia, New South Wales
St George Dermatology & Skin Cancer Centre /ID# 213888 Not yet recruiting
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Veracity Clinical Research /ID# 213889 Not yet recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Skin Health Institute Inc /ID# 213886 Not yet recruiting
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Fremantle Dermatology /ID# 213887 Not yet recruiting
Fremantle, Western Australia, Australia, 6160
France
CHU d'Angers /ID# 214430 Not yet recruiting
Angers, France, 49933
Hopital Saint Joseph /ID# 214429 Not yet recruiting
Marseille, France, 13008
Chr Metz Thionville /Id# 214432 Not yet recruiting
Metz, France, 57085
Hopital Begin /ID# 214431 Not yet recruiting
Saint Mande, France, 94160
Hopital Nord /ID# 214618 Not yet recruiting
Saint Priest En Jarez, France, 42270
Germany
Universitaetsklinikum Erlangen /ID# 214228 Not yet recruiting
Erlangen, Bayern, Germany, 91054
Universitatsklinikum Frankfurt /ID# 215889 Not yet recruiting
Frankfurt, Hessen, Germany, 60590
Charité Universitätsmedizin Campus Mitte /ID# 215691 Not yet recruiting
Berlin, Germany, 10117
Univ Hosp Schleswig-Holstein /ID# 214469 Not yet recruiting
Kiel, Germany, 24105
TU Uniklinik Munchen /ID# 214506 Not yet recruiting
Munich, Germany, 80802
Israel
Rabin Medical Center /ID# 213813 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Ha'Emek Medical Center /ID# 214059 Recruiting
Afula, Israel, 18341
Sheba Medical Center /ID# 213815 Recruiting
Ramat Gan, Israel, 5262100
Ichilov Medical Center /ID# 213812 Recruiting
Tel Aviv, Israel, 64239
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 214750 Not yet recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 214749 Not yet recruiting
Rozzano, Milano, Italy, 20089
A.O. Policlinico Sant'Orsola Malpighi /ID# 214745 Not yet recruiting
Bologna, Italy, 40138
Ospedale San Giovanni di Dio /ID# 214748 Not yet recruiting
Cagliari, Italy, 9124
AO Univ di Modena /ID# 214751 Not yet recruiting
Modena, Italy, 41100
University of Naples Federico /ID# 214752 Not yet recruiting
Naples, Italy, 80131
Spain
Hosp Univ Fundacion Alcorcon /ID# 214033 Not yet recruiting
Alcorcon, Spain, 28922
Hospital Parc de Salut del Mar /ID# 214034 Not yet recruiting
Barcelona, Spain, 08003
Hospital Univ Germans Trias I /ID# 214031 Not yet recruiting
Barcelona, Spain, 08916
Hospital Puerta del Mar /ID# 214428 Not yet recruiting
Cadiz, Spain, 11009
Hospital Universitario La Paz /ID# 214341 Not yet recruiting
Madrid, Spain, 28046
Hosp Univ Politecnico la Fe /ID# 214032 Not yet recruiting
Valencia, Spain, 46026
Taiwan
National Taiwan Univ Hosp /ID# 213630 Recruiting
Taipei City, Taipei, Taiwan, 10002
Chung Shan Medical University /ID# 213634 Not yet recruiting
Taichung City, Taiwan, 40201
MacKay Memorial Hospital /ID# 213845 Not yet recruiting
Taipei City, Taiwan, 10449
Linkou Chang Gung Memorial Ho /ID# 213631 Not yet recruiting
Taoyuan City, Taiwan, 33305
United Kingdom
NHS Fife /ID# 213881 Not yet recruiting
Dunfermline, Fife, United Kingdom, KY12 0SU
Russells Hall Hospital, Dudley /ID# 213878 Not yet recruiting
Dudley, United Kingdom, DY1 2HQ
Chapel Allerton Hospital /ID# 213880 Not yet recruiting
Leeds, United Kingdom, LS7 4SA
Newcastle upon Tyne Hospitals /ID# 213877 Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
The University of Manchester /ID# 213873 Recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04102007    
Other Study ID Numbers: M19-164
2019-000904-14 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents