Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03255382 | A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy | PHASE3 | COMPLETED | 120 | — | — | Aug 22, 2017 | Jul 6, 2018 | Sep 13, 2019 | 23 | Germany |
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
| Arm | Type | Description |
|---|---|---|
| Risankizumab | EXPERIMENTAL | Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16. |
| Fumaderm | ACTIVE_COMPARATOR | Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows. |
| Name | Type | Description |
|---|---|---|
| Fumaderm | DRUG | Fumaderm tablet administered orally |
| risankizumab | DRUG | Risankizumab administered by subcutaneous (SC) injection |
Inclusion Criteria: * Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant * Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis...