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

  • STATUS
    Recruiting
  • End date
    Oct 26, 2022
  • participants needed
    250
  • sponsor
    AbbVie
Updated on 3 July 2021
Investigator
AbbVie_Call Center
Primary Contact
Arkansas Research Trials /ID# 225497 (8.0 mi away) Contact
+80 other location
secukinumab
ixekizumab

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.

Details
Condition Plaque Psoriasis
Treatment risankizumab
Clinical Study IdentifierNCT04102007
SponsorAbbVie
Last Modified on3 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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