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: Active, not recruiting
• Trial end date: 2022-10-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal; Ixekizumab

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.

• 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.