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Ixekizumab

Phase 3

Psoriasis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jan 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials6
Total Enrollment1,873
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06588283Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or OverweightPHASE3 ACTIVE NOT_RECRUITING 250Sep 30, 2024May 1, 2026Jan 20, 202672 United States, Puerto Rico
NCT02387801A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe PsoriasisPHASE3 COMPLETED 12Apr 1, 2015Aug 1, 2016Sep 18, 20191 United States
NCT01646177A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)PHASE3 COMPLETED 1,346Jul 28, 2012Jul 22, 2019Jul 28, 2020101 United States, Argentina +8
NCT01624233A Study in Japanese Participants With Moderate-to-Severe PsoriasisPHASE3 COMPLETED 91Jun 1, 2012Sep 1, 2017Sep 10, 201917 Japan
NCT01107457A Study in Participants With Moderate to Severe PsoriasisPHASE2 COMPLETED 142Apr 1, 2010Jul 1, 2016Sep 24, 201934 United States, Denmark
NCT03073213A Study of Ixekizumab in Chinese Participants With Psoriasis VulgarisPHASE1 COMPLETED 32Apr 13, 2017May 14, 2019Jul 22, 20203 China
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Study Endpoints
Primary Endpoints
Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
Baseline to Week 36

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.

Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
Baseline through Week 12

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.

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

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.

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

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.

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

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).

Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Week 12

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.

Percentage of PASI Improvement From Baseline to 12 Week Endpoint
Baseline to Week 12

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: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.

Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197

Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.

Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
day 57 (Pre-dose), 59, 61, 64, 67, 71

Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).

Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85

Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Secondary Endpoints
Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction
Baseline to Week 36
Percentage of Participants Achieving PASI 100
Baseline to Week 36
Percentage of Participants Achieving At Least 10% Weight Reduction
Baseline to Week 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IxekizumabEXPERIMENTALIxekizumab administered subcutaneous (SC).
Ixekizumab and TirzepatideEXPERIMENTALIxekizumab concomitantly administered with tirzepatide SC.
Ixekizumab Dosing Q2WEXPERIMENTAL160 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 Q4WEXPERIMENTAL160 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.
PlaceboPLACEBO_COMPARATORPlacebo 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 etanerceptACTIVE_COMPARATORAdministered 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 2EXPERIMENTALAdministered 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 1EXPERIMENTALAdministered 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 ixekizumabEXPERIMENTALAdministered 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 IxekizumabEXPERIMENTALPart 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 IxekizumabEXPERIMENTALPart 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 IxekizumabEXPERIMENTALPart 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 IxekizumabEXPERIMENTALPart 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 IxekizumabEXPERIMENTALPart 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 doseEXPERIMENTALParticipants received single dose of 80mg Ixekizumab by subcutaneous injection.
Ixekizumab Multiple Regimen 1 (80mg Q2W)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Interventions
NameTypeDescription
IxekizumabDRUGAdministered SC
TirzepatideDRUGAdministered SC.
PlaceboDRUGAdministered SC
50 mg etanerceptDRUGAdministered SC
80 mg ixekizumabDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites72

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 ...

Countries:United StatesPuerto RicoArgentinaBulgariaCanadaChileGermanyHungaryMexicoPolandRussiaJapanDenmarkChina
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06588283primaryCompletionDate: changed
LOWMay 24, 2026NCT06588283studyFirstPostDate: changed