Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ixekizumab Auto-Injector · 1 trial · 1 indication
Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.
AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.
| Arm | Type | Description |
|---|---|---|
| 80 mg Ixekizumab Auto-Injector | EXPERIMENTAL | Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W). |
| 80 mg Ixekizumab Prefilled Syringe | EXPERIMENTAL | Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W. |
| Name | Type | Description |
|---|---|---|
| Ixekizumab Auto-Injector | DRUG | Administered SC by auto-injector |
| Ixekizumab Prefilled Syringe | DRUG | Administered SC by prefilled syringe |
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 Auto-Injector is used for the treatment of moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. It is an investigational therapy being developed by Eli Lilly and Company for this indication.
Ixekizumab Auto-Injector is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with plaque psoriasis.
Ixekizumab Auto-Injector is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for the treatment of plaque psoriasis.
Ixekizumab Auto-Injector was evaluated in a Phase 3 clinical trial with the identifier NCT01777191. This completed study, titled 'Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis,' enrolled 204 participants in the United States and Puerto Rico.
Ixekizumab Auto-Injector is a formulation of the drug ixekizumab, delivered via an auto-injector device. The clinical trial NCT01777191 compared the auto-injector to a prefilled syringe, both containing ixekizumab, in patients with plaque psoriasis.