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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 365 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 : October 28, 2019
Estimated Primary Completion Date : December 13, 2020
Estimated Study Completion Date : October 28, 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.



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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
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04102007     History of Changes
Other Study ID Numbers: M19-164
2019-000904-14 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
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

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents