A Phase 3 interventional study of Mirikizumab and Placebo in Psoriasis, sponsored by Eli Lilly and Company. Completed at 178 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 1,484 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Drug: Mirikizumab
Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Drug: Mirikizumab
Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
Drug: Mirikizumab · Drug: Placebo
Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
Drug: Secukinumab
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Drug: Mirikizumab
Administered SC
Also known as: LY3074828
Administered SC
Administered SC
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Time frame: Week 16
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
Time frame: Week 16
Percentage of Participants Achieving a 75% Improvement in PASI 75
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
Time frame: Week 16
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time frame: Week 16
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time frame: Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time frame: Week 16
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as covariates.
Time frame: Baseline, Week 16
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
Time frame: Baseline, Week 16
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Time frame: Baseline, Week 16
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Time frame: Baseline, Week 16
Change From Baseline on the SF-36 Mental Component Summary (MCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Time frame: Baseline, Week 16
Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time frame: Week 16
Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Time frame: Baseline, Week 16
Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.
Time frame: Baseline, Week 16
Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
Minimum observed serum Ctrough,ss of mirikizumab
Time frame: Week 16
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Time frame: Week 16
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
Time frame: Week 16
| Milestone | 250mg Q4W/250mg Q8W Mirikizumab | 250mg Q4W/125mg Q8W Mirikizumab | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP |
|---|---|---|---|---|---|
| Started | 454 | 451 | 112 | 448 | 19 |
| Received at least one dose of study drug | 454 | 450 | 112 | 448 | 19 |
| Completed | 443 | 434 | 104 | 437 | 19 |
| Not completed | 11 | 17 | 8 | 11 | 0 |
| Withdrew: Adverse event | 2 | 2 | 1 | 3 | 0 |
| Withdrew: Death | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 3 | 2 | 2 | 0 |
| Withdrew: Lost to follow-up | 3 | 5 | 2 | 3 | 0 |
| Withdrew: Physician decision | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Screen failure | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 4 | 3 | 2 | 0 |
| Milestone | 250mg Q4W/250mg Q8W Mirikizumab | 250mg Q4W/125mg Q8W Mirikizumab | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP |
|---|---|---|---|---|---|
| Started | 443 | 434 | 104 | 437 | 19 |
| Completed | 421 | 418 | 96 | 400 | 13 |
| Not completed | 22 | 16 | 8 | 37 | 6 |
| Withdrew: Adverse event | 6 | 5 | 1 | 11 | 4 |
| Withdrew: Lack of efficacy | 3 | 2 | 5 | 9 | 0 |
| Withdrew: Lost to follow-up | 4 | 2 | 1 | 5 | 2 |
| Withdrew: Other | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 2 | 0 | 2 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 2 | 1 | 8 | 0 |
| Milestone | 250mg Q4W/250mg Q8W Mirikizumab | 250mg Q4W/125mg Q8W Mirikizumab | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP |
|---|---|---|---|---|---|
| Started | 38 | 35 | 18 | 47 | 8 |
| Completed | 27 | 21 | 7 | 23 | 8 |
| Not completed | 11 | 14 | 11 | 24 | 0 |
| Withdrew: Adverse event | 4 | 5 | 1 | 8 | 0 |
| Withdrew: Lack of efficacy | 3 | 4 | 5 | 4 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 5 | 0 |
| Withdrew: Physician decision | 0 | 2 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 | 3 | 6 | 0 |
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline | 6.3 (1.8 to 10.7) | 76.3 (72.4 to 80.3) | 79.7 (77.0 to 82.3) |
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline | 6.3 (1.8 to 10.7) | 72.8 (68.6 to 76.9) | 74.4 (71.5 to 77.2) |
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants Achieving a 75% Improvement in PASI 75 | 8.0 (3.0 to 13.1) | 89.5 (86.7 to 92.3) | 89.5 (87.5 to 91.5) |
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement | 1.8 (0.0 to 4.2) | 54.5 (49.9 to 59.1) | 53.1 (49.9 to 56.4) |
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline | 1.9 (0.0 to 4.4) | 28.7 (24.4 to 33.1) | 25.0 (22.1 to 27.9) |
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5 | 5.9 (1.3 to 10.6) | 60.4 (55.5 to 65.2) | 59.6 (56.2 to 62.9) |
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as covariates.
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | -1.33 ± 1.030 | -5.79 ± 0.541 | -6.28 ± 0.383 |
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | -3.62 ± 0.676 | -18.22 ± 0.365 | -18.78 ± 0.286 |
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | 0.20 ± 1.494 | -11.24 ± 0.774 | -9.38 ± 0.580 |
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | 0.57 ± 0.633 | 4.38 ± 0.358 | 4.03 ± 0.291 |
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change From Baseline on the SF-36 Mental Component Summary (MCS) | 0.50 ± 0.701 | 4.21 ± 0.398 | 4.45 ± 0.321 |
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2 | 7.3 (2.4 to 12.1) | 71.8 (67.6 to 76.1) | 72.3 (69.3 to 75.2) |
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
| Score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Absenteeism | -0.48 ± 1.753 | -2.48 ± 0.995 | -2.20 ± 0.844 |
| Presenteeism | -3.36 ± 2.104 | -18.95 ± 1.204 | -18.95 ± 1.020 |
| Overall work impairment | -2.77 ± 2.448 | -18.49 ± 1.401 | -19.21 ± 1.187 |
| Impairment in Activities Performed Outside of Work | -5.86 ± 1.847 | -25.71 ± 1.061 | -24.17 ± 0.885 |
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.
| score on a scale | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11. | -4.79 ± 2.266 | -5.10 ± 0.935 | -5.28 ± 0.733 |
Minimum observed serum Ctrough,ss of mirikizumab
| Microgram per milliliter (ug/mL) | Mirikizumab 250mg Q4W |
|---|---|
| Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab | 2.40 ± 112 |
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority) | 6.3 (1.8 to 10.7) | 76.3 (72.4 to 80.3) | 79.7 (77.0 to 82.3) |
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 psoriasis (PsO) 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 PsO) to 72 (the most severe disease).
| percentage of participants | Placebo | 300mg Secukinumab | 250mg Q4W Mirikizumab |
|---|---|---|---|
| Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority) | 6.3 (1.8 to 10.7) | 72.8 (68.6 to 76.9) | 74.4 (71.5 to 77.2) |
Collected over Up to 64 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo / Induction Period | 0/112 (0%) | 0/112 (0%) | 68/112 (60.7%) |
| 300mg Secukinumab / Induction Period | 0/448 (0%) | 11/448 (2.5%) | 257/448 (57.4%) |
| 250mg Mirikizumab Q4W / Induction Period | 1/904 (0.1%) | 15/904 (1.7%) | 520/904 (57.5%) |
| 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period | 0/19 (0%) | 2/19 (10.5%) | 14/19 (73.7%) |
| 300mg Secukinumab/Maintenance Period | 0/437 (0%) | 15/437 (3.4%) | 292/437 (66.8%) |
| 125mg Mirikizumab Q8W / Maintenance Period | 0/434 (0%) | 13/434 (3%) | 271/434 (62.4%) |
| 250mg Mirikizumab Q8W / Maintenance Period | 0/443 (0%) | 10/443 (2.3%) | 282/443 (63.7%) |
| 250mg Mirikizumab / Maintenance Period | 0/104 (0%) | 0/104 (0%) | 0/104 (0%) |
| 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period | 0/18 (0%) | 3/18 (16.7%) | 14/18 (77.8%) |
| Placebo / Follow-up Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 300mg Secukinumab / Follow-up Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 250mg Mirikizumab Q4W / Follow-up Period | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period | 0/29 (0%) | 3/29 (10.3%) | 3/29 (10.3%) |
| 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period | 0/35 (0%) | 0/35 (0%) | 6/35 (17.1%) |
| Placebo/250mg Mirikizumab / Follow-up Period | 0/14 (0%) | 0/14 (0%) | 4/14 (28.6%) |
| 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| 300mg Secukinumab /300mg Secukinumab / Follow-up Period | 0/43 (0%) | 0/43 (0%) | 7/43 (16.3%) |
| Event | Placebo / Induction Period | 300mg Secukinumab / Induction Period | 250mg Mirikizumab Q4W / Induction Period | 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period | 300mg Secukinumab/Maintenance Period | 125mg Mirikizumab Q8W / Maintenance Period | 250mg Mirikizumab Q8W / Maintenance Period | 250mg Mirikizumab / Maintenance Period | 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period | Placebo / Follow-up Period | 300mg Secukinumab / Follow-up Period | 250mg Mirikizumab Q4W / Follow-up Period | 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period | 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period | 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period | Placebo/250mg Mirikizumab / Follow-up Period | 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period | 300mg Secukinumab /300mg Secukinumab / Follow-up Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CataractEye disorders | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 0/434 | 0/443 | 0/104 | 1/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Radius fractureInjury, poisoning and procedural complications | 0/112 | 0/448 | 0/904 | 0/19 | 1/437 | 0/434 | 0/443 | 0/104 | 1/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Pustular psoriasisSkin and subcutaneous tissue disorders | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 0/434 | 0/443 | 0/104 | 1/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Angina pectorisCardiac disorders | 0/112 | 0/448 | 0/904 | 1/19 | 0/437 | 1/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Irritable bowel syndromeGastrointestinal disorders | 0/112 | 0/448 | 0/904 | 1/19 | 0/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| MeningitisInfections and infestations | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 1/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Lung adenocarcinoma stage iNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 1/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 1/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 1/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Atrial fibrillationCardiac disorders | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 2/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| NephrolithiasisRenal and urinary disorders | 0/112 | 2/448 | 0/904 | 0/19 | 0/437 | 0/434 | 1/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Event | Placebo / Induction Period | 300mg Secukinumab / Induction Period | 250mg Mirikizumab Q4W / Induction Period | 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period | 300mg Secukinumab/Maintenance Period | 125mg Mirikizumab Q8W / Maintenance Period | 250mg Mirikizumab Q8W / Maintenance Period | 250mg Mirikizumab / Maintenance Period | 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period | Placebo / Follow-up Period | 300mg Secukinumab / Follow-up Period | 250mg Mirikizumab Q4W / Follow-up Period | 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period | 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period | 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period | Placebo/250mg Mirikizumab / Follow-up Period | 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period | 300mg Secukinumab /300mg Secukinumab / Follow-up Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndromeGastrointestinal disorders | 1/112 | 0/448 | 0/904 | 1/19 | 0/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 1/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| NasopharyngitisInfections and infestations | 18/112 | 55/448 | 144/904 | 4/19 | 61/437 | 60/434 | 67/443 | 0/104 | 4/18 | 0/4 | 0/4 | 1/9 | 0/1 | 0/29 | 0/35 | 0/14 | 2/6 | 2/43 |
| Diverticulum intestinalGastrointestinal disorders | 0/112 | 0/448 | 0/904 | 0/19 | 1/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 1/6 | 0/43 |
| Otitis mediaInfections and infestations | 0/112 | 0/448 | 0/904 | 1/19 | 2/437 | 2/434 | 1/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 1/6 | 0/43 |
| Biopsy skinInvestigations | 0/112 | 0/448 | 0/904 | 0/19 | 0/437 | 0/434 | 0/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 1/6 | 0/43 |
| Weight decreasedInvestigations | 0/112 | 0/448 | 2/904 | 0/19 | 1/437 | 3/434 | 2/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 1/6 | 0/43 |
| Injection site reactionGeneral disorders | 1/112 | 4/448 | 26/904 | 1/19 | 3/437 | 14/434 | 14/443 | 0/104 | 2/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| UrticariaSkin and subcutaneous tissue disorders | 0/112 | 1/448 | 8/904 | 0/19 | 2/437 | 3/434 | 4/443 | 0/104 | 0/18 | 0/4 | 0/4 | 1/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| ConstipationGastrointestinal disorders | 0/112 | 2/448 | 4/904 | 2/19 | 0/437 | 0/434 | 1/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 1/43 |
| PruritusSkin and subcutaneous tissue disorders | 2/112 | 4/448 | 22/904 | 2/19 | 8/437 | 2/434 | 4/443 | 0/104 | 0/18 | 0/4 | 0/4 | 0/9 | 0/1 | 0/29 | 0/35 | 0/14 | 0/6 | 0/43 |
| Age, Customized(Participants) | Mirikizumab 250mg Q4W/250mg Q8W | 250mg Mirikizumab /125mg Q8W | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP | Total |
|---|---|---|---|---|---|---|
| <65 | 417 | 398 | 103 | 399 | 14 | 1331 |
| >=65 | 37 | 53 | 9 | 49 | 5 | 153 |
| Sex: Female, Male(Participants) | Mirikizumab 250mg Q4W/250mg Q8W | 250mg Mirikizumab /125mg Q8W | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP | Total |
|---|---|---|---|---|---|---|
| Female | 158 | 140 | 30 | 137 | 1 | 466 |
| Male | 296 | 311 | 82 | 311 | 18 | 1018 |
| Ethnicity (NIH/OMB)(Participants) | Mirikizumab 250mg Q4W/250mg Q8W | 250mg Mirikizumab /125mg Q8W | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 9 | 15 | 4 | 10 | 0 | 38 |
| Not Hispanic or Latino | 79 | 71 | 12 | 72 | 0 | 234 |
| Unknown or Not Reported | 366 | 365 | 96 | 366 | 19 | 1212 |
| Race (NIH/OMB)(Participants) | Mirikizumab 250mg Q4W/250mg Q8W | 250mg Mirikizumab /125mg Q8W | Placebo/250mg Mirikizumab | 300mg Secukinumab | Japan GPP/EP | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 1 | 2 | 0 | 7 |
| Asian | 81 | 66 | 12 | 70 | 19 | 248 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 1 | 0 | 3 |
| Black or African American | 7 | 7 | 2 | 8 | 0 | 24 |
| White | 361 | 372 | 97 | 365 | 0 | 1195 |
| More than one race | 2 | 2 | 0 | 2 | 0 | 6 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 1 |
Showing the first 100 of 178 sites across 16 countries.
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Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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