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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01474512 | A Phase 3 Study in Participants With Moderate to Severe Psoriasis | PHASE3 | COMPLETED | 1,296 | — | — | Nov 16, 2011 | Sep 20, 2018 | Oct 3, 2019 | 104 | United States, Australia +9 |
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
| Arm | Type | Description |
|---|---|---|
| 80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W) | EXPERIMENTAL | Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 \[every 2 weeks (Q2W)\] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 \[every 4 weeks (Q4W)\] or Dosing Regimen 3 \[every 12 weeks Q12W)\]. |
| 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | EXPERIMENTAL | Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W). |
| 80 mg Ixekizumab Dosing Regimen 3 (Q12W) | EXPERIMENTAL | Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W. |
| Placebo | PLACEBO_COMPARATOR | Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W). |
| Name | Type | Description |
|---|---|---|
| 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization * At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization * Static Physician Global Assessment (sPGA) sco...