| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06588283 | Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight | PHASE3 | ACTIVE NOT_RECRUITING | 250 | — | — | Sep 30, 2024 | May 1, 2026 | Jan 20, 2026 | 72 | United States, Puerto Rico |
| NCT02387801 | A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis | PHASE3 | COMPLETED | 12 | — | — | Apr 1, 2015 | Aug 1, 2016 | Sep 18, 2019 | 1 | United States |
| NCT01646177 | A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3) | PHASE3 | COMPLETED | 1,346 | — | — | Jul 28, 2012 | Jul 22, 2019 | Jul 28, 2020 | 101 | United States, Argentina +8 |
| NCT01624233 | A Study in Japanese Participants With Moderate-to-Severe Psoriasis | PHASE3 | COMPLETED | 91 | — | — | Jun 1, 2012 | Sep 1, 2017 | Sep 10, 2019 | 17 | Japan |
| NCT01107457 | A Study in Participants With Moderate to Severe Psoriasis | PHASE2 | COMPLETED | 142 | — | — | Apr 1, 2010 | Jul 1, 2016 | Sep 24, 2019 | 34 | United States, Denmark |
| NCT03073213 | A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris | PHASE1 | COMPLETED | 32 | — | — | Apr 13, 2017 | May 14, 2019 | Jul 22, 2020 | 3 | China |
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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI score compared to baseline.
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to 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 by itself and the scores were then combined for the final PASI. Final PASI=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).
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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to 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 (none) to 4 (very severe). Each area is scored by itself and the scores were 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 psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
| Arm | Type | Description |
|---|---|---|
| Ixekizumab | EXPERIMENTAL | Ixekizumab administered subcutaneous (SC). |
| Ixekizumab and Tirzepatide | EXPERIMENTAL | Ixekizumab concomitantly administered with tirzepatide SC. |
| Ixekizumab Dosing Q2W | EXPERIMENTAL | 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. |
| Ixekizumab Dosing Q4W | EXPERIMENTAL | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44. |
| Placebo | PLACEBO_COMPARATOR | Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2. |
| 50 mg etanercept | ACTIVE_COMPARATOR | Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 |
| 80 mg ixekizumab Dosing Regimen 2 | EXPERIMENTAL | Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264. |
| 80 mg ixekizumab Dosing Regimen 1 | EXPERIMENTAL | Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2. |
| 80 mg ixekizumab | EXPERIMENTAL | Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks. |
| 10 mg Ixekizumab | EXPERIMENTAL | Part A: 10 milligrams (mg) ixekizumab given subcutaneous (SC) on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344. |
| 25 mg Ixekizumab | EXPERIMENTAL | Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344. |
| 75 mg Ixekizumab | EXPERIMENTAL | Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344. |
| 150 mg Ixekizumab | EXPERIMENTAL | Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344. |
| 120 mg Ixekizumab | EXPERIMENTAL | Part B: (optional) 120 mg ixekizumab given SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Part C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344. |
| Ixekizumab single dose | EXPERIMENTAL | Participants received single dose of 80mg Ixekizumab by subcutaneous injection. |
| Ixekizumab Multiple Regimen 1 (80mg Q2W) | EXPERIMENTAL | Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. |
| Ixekizumab Multiple Regimen 2 (80mg Q4W) | EXPERIMENTAL | Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| Ixekizumab | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC. |
| Placebo | DRUG | Administered SC |
| 50 mg etanercept | DRUG | Administered SC |
| 80 mg ixekizumab | DRUG | Administered SC |
Inclusion Criteria: * Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months. * Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12. * Have ≥10% body surface area (BSA) involvement. * Have obesity, body ...