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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 9 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 13 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-001, ORKA-002 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Amgen Inc. | AMGN | 1 | PHASE3 | Apremilast |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 3 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
Ixekizumab Dosing Regimens 1, 2, and 3 is an investigational treatment evaluated for moderate to severe psoriasis. It was studied in a Phase 3 trial in adults with this skin condition. The regimens refer to different dosing schedules of ixekizumab, a monoclonal antibody developed by Eli Lilly and Company.
Ixekizumab Dosing Regimens 1, 2, and 3 targets interleukin-17A (IL-17A). It is an inhibitor of this cytokine, which is involved in inflammatory pathways associated with psoriasis. By targeting IL-17A, the drug aims to reduce inflammation that drives the condition.
Eli Lilly and Company (ticker: LLY) is the developer of Ixekizumab Dosing Regimens 1, 2, and 3. The company is responsible for the clinical development of this monoclonal antibody for psoriasis.
Ixekizumab Dosing Regimens 1, 2, and 3 is in Phase 3 development. The single Phase 3 trial for this asset has been completed. It is an investigational treatment and has not been approved by the FDA for the studied indication.
Ixekizumab Dosing Regimens 1, 2, and 3 was studied in one Phase 3 clinical trial, NCT01474512, titled "A Phase 3 Study in Participants With Moderate to Severe Psoriasis." The trial enrolled 1,296 participants, was randomized, double-blind, and placebo-controlled, and is now completed.