Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2439821
Ixekizumab Auto-Injector · 4 trials · 2 indications
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.
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) \* 100.
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
| 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. |
| 3 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\] |
| 10 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 30 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 180 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (TNFa-IR population) | EXPERIMENTAL | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\] |
| 180 mg LY2439821 (TNFa-IR population) | EXPERIMENTAL | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (bDMARD-naive population) | PLACEBO_COMPARATOR | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (TNFa-IR population) | PLACEBO_COMPARATOR | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 30 milligrams (mg) LY2439821 | EXPERIMENTAL | Participants will start receiving LY2439821 30 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). |
| 80 mg LY2439821 | EXPERIMENTAL | Participants will start receiving LY2439821 80 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). |
| 160 mg LY2439821 | EXPERIMENTAL | Participants will start receiving LY2439821 160 mg once every 2 weeks for the first 3 doses and then once every 4 weeks until Week 44. |
| 30 mg LY2439821 | EXPERIMENTAL | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| 180 mg LY2439821 | EXPERIMENTAL | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| Placebo | PLACEBO_COMPARATOR | Placebo is administered subcutaneously in the same manner as active drug in each dose group |
| 120 mg LY2439821 | EXPERIMENTAL | Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week |
| Name | Type | Description |
|---|---|---|
| Ixekizumab Auto-Injector | DRUG | Administered SC by auto-injector |
| Ixekizumab Prefilled Syringe | DRUG | Administered SC by prefilled syringe |
| LY2439821 | BIOLOGICAL | Subcutaneous |
| Placebo | DRUG | Subcutaneous |
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 being developed for the treatment of moderate to severe plaque psoriasis in adults. It is a monoclonal antibody formulation delivered by auto-injector, studied in a Phase 3 trial in participants aged 18 years and older with this dermatologic condition.
Ixekizumab Auto-Injector targets interleukin-17A (IL-17A). It is an inhibitor of this cytokine, which is involved in the inflammatory pathways underlying plaque psoriasis. By binding IL-17A, the monoclonal antibody is designed to reduce the inflammatory response associated with the disease.
Ixekizumab Auto-Injector is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. Eli Lilly is the sponsor of the clinical program evaluating this auto-injector presentation in plaque psoriasis.
Ixekizumab Auto-Injector is in Phase 3 clinical development. The program includes one completed Phase 3 trial. As an investigational product, it has not been approved by the FDA for the studied indication and remains under clinical evaluation.
Ixekizumab Auto-Injector has been evaluated in the Phase 3 trial NCT01777191, titled Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis. The trial enrolled 204 participants across the United States and Puerto Rico and is now completed.
Ixekizumab Auto-Injector refers specifically to the auto-injector presentation of ixekizumab, a monoclonal antibody targeting IL-17A. The Phase 3 trial NCT01777191 compared administration via auto-injector or prefilled syringe in participants with moderate to severe plaque psoriasis.