Phase 3
Completed N=244
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
Source: ClinicalTrials.gov NCT04102007 ↗Enrolled (actual)
244
Serious AEs
7.0%
Results posted
Mar 2023
Primary outcomePrimary: Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 — 140 Participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study.
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 (With the last dose being administered at Week 40). 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.
Linked Publications
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Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 |
152 | — |
| SECONDARY Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) |
66 | — |
| SECONDARY Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 |
115 | — |
| SECONDARY Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 |
51 | — |
| SECONDARY Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 |
152 | — |
| SECONDARY Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) |
66 | — |
| SECONDARY Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 |
115 | — |
| SECONDARY Proportion of Participants Achieving a PSS 0 |
67 | — |
| SECONDARY Time to Achieve sPGA 0/1 |
30; 57; 199 | — |
| SECONDARY Time to Achieve sPGA 0 |
121; 370; NA | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04102007) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.