Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ixekizumab Dosing Regimens 1, 2, and 3 · 1 trial · 1 indication
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...
Ixekizumab Dosing Regimens 1, 2, and 3 is an investigational small molecule being developed for the treatment of moderate to severe psoriasis. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Ixekizumab Dosing Regimens 1, 2, and 3 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY.
Ixekizumab Dosing Regimens 1, 2, and 3 is in Phase 3 clinical development. It is an investigational drug and has not yet been approved for use in patients.
Ixekizumab Dosing Regimens 1, 2, and 3 has been studied in one completed Phase 3 clinical trial, identified as NCT01474512. This trial enrolled 1,296 participants with moderate to severe psoriasis and was conducted in multiple countries including the United States, Australia, Canada, and Japan.
Ixekizumab Dosing Regimens 1, 2, and 3 refers to specific dosing schedules of the drug ixekizumab. The clinical trial NCT01474512 evaluated these three dosing regimens in patients with moderate to severe psoriasis.