Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ixekizumab, Ixekizumab Auto-Injector, Ixekizumab Prefilled Syringe
LY2439821 · 27 trials · 15 indications
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.
ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments: 1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) 2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \_NRS) 3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS) 4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or 5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from 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 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 Ps) to 72 (the most severe disease).
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
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 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 Ps) to 72 (the most severe disease).
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity \& severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose \& date of last attended visit in Period 3.
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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 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 Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
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.
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 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
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).
The primary outcome will be the proportion of subjects achieving a 2-point reduction in the 5-point investigator global assessment for the target ulcer at Week 12. The measure type and unit of measure are the proportion of participants. The IGA utilizes a 5 point Investigator Global Assessment measuring disease severity from 0- clear, 1-minimal, 2-mild, 3-moderate, 4- severe. 4 is the worst
Clinical improvement will be measured by the Psoriasis Area and Severity Index (PASI) score. PASI is a scale that measures the severity (redness, scale, and elevation) of each body surface area of skin involved in psoriasis (a disease that has some similarities with PRP). Redness, scale, and elevation are each scored on a 0-4 point scale, added together, and multiplied by each body surface area involved (head and neck, trunk, upper limbs, lower limbs). The maximum score is 72 which would indicate the worst disease over every surface of someone's body. A scale of zero would indicate normal skin.
Median time to cessation of blister formation during the 12 weeks of therapy.
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.
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.
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).
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 |
|---|---|---|
| Ixekizumab | EXPERIMENTAL | Ixekizumab administered subcutaneous (SC). |
| Ixekizumab and Tirzepatide | EXPERIMENTAL | Ixekizumab concomitantly administered with tirzepatide SC. |
| Ixekizumab - OLT Period | EXPERIMENTAL | Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight: * Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16. * 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16. * 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16. |
| Adalimumab - OLT Period | ACTIVE_COMPARATOR | Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight: * Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W). * 10.0 to \<30.0 kg: 20 mg SC Q2W. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection during the double-blind period. During the extension period, they received starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during follow-up period. |
| Ixekizumab 80mg Q4W | EXPERIMENTAL | Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period. |
| Ixekizumab 80mg Q2W | EXPERIMENTAL | Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period. |
| Ixekizumab (IXE) 80Q4W | EXPERIMENTAL | Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W). |
| Ixekizumab (IXE) 80Q2W | EXPERIMENTAL | Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W). |
| Open-Label Etanercept | EXPERIMENTAL | Etanercept given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period. Participants will only be randomized to etanercept in countries where it is approved for severe pediatric psoriasis treatment. |
| Q2W Ixekizumab | EXPERIMENTAL | Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period. Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44. |
| Q4W Ixekizumab | EXPERIMENTAL | Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period. Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44. |
| Adalimumab | ACTIVE_COMPARATOR | Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52. |
| Ustekinumab | ACTIVE_COMPARATOR | 45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding. |
| Ixekizumab Open Label | EXPERIMENTAL | Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64). |
| IXE80Q2W Non-randomized | EXPERIMENTAL | Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period. |
| 80 mg Ixekizumab Q2W | EXPERIMENTAL | 160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 80 mg Ixekizumab Q4W | EXPERIMENTAL | 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 80 mg Ixekizumab Q4W/Q2W | EXPERIMENTAL | 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort | EXPERIMENTAL | 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort | EXPERIMENTAL | 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort | EXPERIMENTAL | 160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind. |
| 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. |
| 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. |
| Ixekizumab Q2W | EXPERIMENTAL | Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W). |
| Ixekizumab Q4W | EXPERIMENTAL | Administered by 80 mg SC injection every 4 weeks (Q4W). |
| Adalimumab Q2W | ACTIVE_COMPARATOR | Administered by 40 mg SC injection Q2W. |
| 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. |
| Ixekizumab (Taltz) | EXPERIMENTAL | We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment. |
| Ixekizumab treatment arm | EXPERIMENTAL | Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 |
| 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. |
| 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. |
| 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. |
| 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 |
| 120 mg LY2439821 | EXPERIMENTAL | Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week |
| Name | Type | Description |
|---|---|---|
| Ixekizumab | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC. |
| Adalimumab | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Etanercept | DRUG | Administered SC |
| Ustekinumab | DRUG | Administered SC |
| Ixekizumab Auto-Injector | DRUG | Administered SC by auto-injector |
| Ixekizumab Prefilled Syringe | DRUG | Administered SC by prefilled syringe |
| 50 mg etanercept | DRUG | Administered SC |
| 80 mg ixekizumab | DRUG | Administered SC |
| LY2439821 | BIOLOGICAL | Subcutaneous |
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 ...
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LY2439821 is an investigational small molecule being studied for the treatment of rheumatoid arthritis, an autoimmune condition causing joint inflammation and pain. It is developed by Eli Lilly and Company and has completed clinical trials in patients with this condition, though it remains in clinical development and is not yet approved.
LY2439821 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug is an investigational small molecule intended for rheumatoid arthritis and is currently in clinical development, with no approved status.
LY2439821 is in Phase 2 clinical development for rheumatoid arthritis. It has completed three trials, including a Phase 2 study and two Phase 1 studies, all of which are finished. The drug remains investigational and has not received FDA approval.
LY2439821 has completed three clinical trials for rheumatoid arthritis: NCT00966875, a Phase 2 study with 448 participants; NCT01236118, a Phase 1 study with 28 participants; and NCT01253265, a Phase 1 study with 32 participants. All trials are completed and were conducted in multiple countries, including the United States and Japan.
LY2439821 is the primary name for this investigational drug, and no alternative names have been reported. It is a small molecule being studied for rheumatoid arthritis by Eli Lilly and Company, and it is distinct from other drugs in the company's pipeline.