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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 (aimm)

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ClinicalTrials.gov Identifier: NCT04102007
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date December 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04102007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE Drug: Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Other Name: SKYRIZI
Study Arms  ICMJE Risankizumab
Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Intervention: Drug: Risankizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
365
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
250
Estimated Study Completion Date  ICMJE October 28, 2021
Estimated Primary Completion Date December 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   France,   Germany,   Israel,   Italy,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102007
Other Study ID Numbers  ICMJE M19-164
2019-000904-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP