Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01474512 UNCOVER-1 | Psoriasis | Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) Week 12 | Ixe Q2W | 89.1 percentage of participants |
| Ixe Q4W | 82.6 percentage of participants | |||
| Placebo | 3.9 percentage of participants | |||
| NCT01474512 UNCOVER-1 | Psoriasis | Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) Week 12 | Ixe Q2W | 81.8 percentage of participants |
| Ixe Q4W | 76.4 percentage of participants | |||
| Placebo | 3.2 percentage of participants | |||
| NCT01597245 UNCOVER-2 | Psoriasis | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) Week 12 | 50 mg ETN - Induction Period | 41.6 percentage of participants |
| Ixe Q2W - Induction Period | 89.7 percentage of participants | |||
| Ixe Q4W - Induction Period | 77.5 percentage of participants | |||
| Placebo - Induction Period | 2.4 percentage of participants | |||
| NCT01597245 UNCOVER-2 | Psoriasis | Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) Week 12 | 50 mg Etanercept (ETN) - Induction Period | 36.0 percentage of participants |
| Ixe Q2W - Induction Period | 83.2 percentage of participants | |||
| Ixe Q4W - Induction Period | 72.9 percentage of participants | |||
| Placebo - Induction Period | 2.4 percentage of participants | |||
| NCT01624233 UNCOVER-J | Psoriasis | Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) Week (Wk) 12 | 80 mg Ixekizumab (LY2439821) | 98.7 percentage of participants |
| NCT01646177 UNCOVER-3 | Psoriasis | Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) Week 12 | 50 mg Etanercept | 159 Participants |
| 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 310 Participants | |||
| 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 291 Participants | |||
| Placebo | 13 Participants | |||
| NCT01646177 UNCOVER-3 | Psoriasis | Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) Week 12 | 50 mg Etanercept | 204 Participants |
| 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 336 Participants | |||
| 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 325 Participants | |||
| Placebo | 14 Participants | |||
| NCT01695239 SPIRIT-P1 | Arthritis, Psoriatic | Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) Week 24 | Adalimumab Q2W | 57.4 percentage of participants |
| Ixekizumab Q2W | 62.1 percentage of participants | |||
| Ixekizumab Q4W | 57.9 percentage of participants | |||
| Placebo | 30.2 percentage of participants | |||
| NCT01777191 UNCOVER-A | — | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | 80 mg Ixekizumab Auto-Injector | 14.8 micrograms/milliliter (µg/mL) |
| 80 mg Ixekizumab Prefilled Syringe | 15.0 micrograms/milliliter (µg/mL) | |||
| NCT01777191 UNCOVER-A | — | PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | 80 mg Ixekizumab Auto-Injector | 154 micrograms*day/milliliter (µg*day/mL) |
| 80 mg Ixekizumab Prefilled Syringe | 157 micrograms*day/milliliter (µg*day/mL) | |||
| NCT02349295 SPIRIT-P2 | Arthritis, Psoriatic | Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) Week 24 | Ixekizumab 80 mg Q2W | 48.0 Percentage of Participants |
| Ixekizumab 80 mg Q4W | 53.3 Percentage of Participants | |||
| Placebo | 19.5 Percentage of Participants | |||
| NCT02387801 | Psoriasis | Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score Baseline through Week 12 | Ixekizumab Q2W | 5.0 Days |
| Ixekizumab Q4W | 6.0 Days | |||
| NCT02513550 IXORA-P | — | Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Week 52 | 80 mg Ixekizumab Q2W | 85.9 Percentage of participants |
| 80 mg Ixekizumab Q4W | 79 Percentage of participants | |||
| 80 mg Ixekizumab Q4W/Q2W | 83.7 Percentage of participants | |||
| NCT02513550 IXORA-P | — | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) Week 52 | 80 mg Ixekizumab Q2W | 78.6 Percentage of participants |
| 80 mg Ixekizumab Q4W | 70.6 Percentage of participants | |||
| 80 mg Ixekizumab Q4W/Q2W | 72.5 Percentage of participants | |||
| NCT02561806 IXORA-S | — | Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline Week 12 | Ixekizumab | 72.8 percentage of participants |
| Ustekinumab | 42.2 percentage of participants | |||
| NCT02584855 SPIRIT P3 | Arthritis, Psoriatic | Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA]) Double Blind Randomization through Week 104 (or Early Termination or Relapse) | Ixekizumab | NA Weeks |
| Placebo | 22.29 Weeks | |||
| NCT02634801 | — | Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 Week 24 | Fumaric Acid Esters | 22.2 Percentage of Participants |
| Ixekizumab | 90.7 Percentage of Participants | |||
| Methotrexate | 70.4 Percentage of Participants | |||
| NCT02696785 COAST-V | Spondylarthritis | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response Week 16 | Adalimumab | 35.6 percentage of participants |
| IXE80Q2W | 51.8 percentage of participants | |||
| IXE80Q4W | 48.1 percentage of participants | |||
| Placebo | 18.4 percentage of participants | |||
| NCT02696798 COAST-W | Spondylarthritis | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response Week 16 | 80 mg Q2W Ixekizumab | 30.6 Percentage of participants |
| 80 mg Q4W Ixekizumab | 25.4 Percentage of participants | |||
| Placebo | 12.5 Percentage of participants | |||
| NCT02718898 IXORA-Q | Psoriasis | Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) Week 12 | Ixekizumab 80mg Q2W | 55 Participants |
| Placebo | 6 Participants | |||
| NCT02757352 COAST-X | Axial Spondyloarthritis | Percentage of Participants Achieving an ASAS40 Response Week 52 | Ixekizumab 80 mg Q2W | 31.4 percentage of participants |
| Ixekizumab 80 mg Q4W | 30.2 percentage of participants | |||
| Placebo | 13.3 percentage of participants | |||
| NCT02757352 COAST-X | Axial Spondyloarthritis | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response Week 16 | Ixekizumab 80 mg Q2W | 40.2 percentage of participants |
| Ixekizumab 80 mg Q4W | 35.4 percentage of participants | |||
| Placebo | 19.0 percentage of participants | |||
| NCT03073200 Ixora-peds | — | Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab) Week 12 | Ixekizumab | 88.7 percentage of participants |
| Placebo | 25 percentage of participants | |||
| NCT03073200 Ixora-peds | — | Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab) Week 12 | Ixekizumab | 80.9 percentage of participants |
| Placebo | 10.7 percentage of participants | |||
| NCT03129100 | Axial Spondyloarthritis | Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) Week 64 | Combined IXE | 83.3 Percentage of participants |
| Placebo | 54.7 Percentage of participants | |||
| NCT03364309 | Skin Diseases | Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) Week 12 | Ixekizumab 80mg Q2W | 93.8 Percentage of participants |
| Ixekizumab 80mg Q4W | 87.4 Percentage of participants | |||
| Placebo | 8.0 Percentage of participants | |||
| NCT03364309 | Skin Diseases | Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement Week 12 | Ixekizumab 80mg Q2W | 86.4 Percentage of participants |
| Ixekizumab 80mg Q4W | 79.9 Percentage of participants | |||
| Placebo | 3.4 Percentage of participants | |||
| NCT04285229 | Spondylarthritis | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants Week 16 | Ixekizumab 80mg Q4W | 40.9 Percentage of Participants |
| Placebo | 7.8 Percentage of Participants | |||
| NCT04527380 | Arthritis, Juvenile | Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) Week 16 | Ixekizumab - OLT Period | 88.9 Percentage of participants |