Phase 3
Completed N=327
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03478787 ↗Enrolled (actual)
327
Serious AEs
4.6%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 — 65.6; 73.8 percentage of participants
◆ Published Evidence
Established
25citations · ~6 / year
Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study.
Summary
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Linked Publications
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Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 |
65.6; 73.8 | — |
| PRIMARY Percentage of Participants With a PASI 90 at Week 52 |
57.1; 86.6 | < 0.001 sig |
| SECONDARY Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 |
39.9; 65.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52 |
58.3; 87.8 | < 0.001 sig |
| SECONDARY Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 |
69.9; 89.6 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
- Subject must be a candidate for systemic therapy as assessed by the investigator;
- Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion Criteria
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
- 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
- Previous exposure to risankizumab
- Previous exposure to secukinumab
Data sourced from ClinicalTrials.gov (NCT03478787) 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.