A Phase 3 interventional study of Mirikizumab and Placebo in Psoriasis, sponsored by Eli Lilly and Company. Completed at 69 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-25.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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Among 35 studies in Psoriasis by Eli Lilly and Company — 1 open to participants now, 1 under way, none of them phase 3. Psoriasis · Eli Lilly and Company.
Among the 35 studies in Psoriasis by Eli Lilly and Company, this one is the 8th largest by enrollment, is one of 6 that started in 2018, is one of 15 in phase 3, and was the 22nd registered.
2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.
Browse Psoriasis studies →1 of the 35 studies in Psoriasis by Eli Lilly and Company is open now, in 1 country. Recruiting first, the newest first:
Eli Lilly and Company · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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35 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 530 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 162 across the 35 interventional studies. Of the 34 that completed or were terminated, 28 (82%) have results posted.
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Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 35 studies in Psoriasis by Eli Lilly and Company, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (\<PASI 90).
Drug: Mirikizumab
Induction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (\< PASI 90).
Drug: Placebo
Administered SC
Also known as: LY3074828
Administered SC
Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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 From Baseline in Psoriasis Area and Severity Score (PASI 90)
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 From Baseline in PASI (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 4
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (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 Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)
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) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥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
Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
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 52
Change 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: 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). LS Mean was calculated using 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: Week 16
Change 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). LS Mean was calculated using 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: Week 16
Change From Baseline on the Short Form (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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
Time frame: Baseline, Week 16
Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
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: Baseline, Week 16
Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
Time frame: Baseline, Week 16
Change From Baseline in Quick Inventory of Depressive Symptomology (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. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
Time frame: Baseline, Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
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
Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
Time frame: Week 16: Day 113
| Milestone | Placebo Q4W | 250 mg Miri Q4W | Placebo Q4W to Placebo Q8W (Placebo Responder) | Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) |
|---|---|---|---|---|---|---|---|---|
| Started | 107 | 423 | 0 | 0 | 0 | 0 | 0 | 0 |
| Received at least one dose of study drug | 107 | 422 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 101 | 412 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 11 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Screen failure | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo Q4W | 250 mg Miri Q4W | Placebo Q4W to Placebo Q8W (Placebo Responder) | Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 7 | 94 | 91 | 90 | 91 | 140 |
| Relapse | 0 | 0 | 1 | 0 | 41 | 3 | 2 | 0 |
| Roll over to i6t-mc-amah (nct03556202) | 0 | 0 | 6 | 88 | 86 | 85 | 87 | 121 |
| Completed | 0 | 0 | 6 | 90 | 86 | 86 | 87 | 123 |
| Not completed | 0 | 0 | 1 | 4 | 5 | 4 | 4 | 17 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 4 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 9 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 2 | 1 | 2 | 2 |
| Milestone | Placebo Q4W | 250 mg Miri Q4W | Placebo Q4W to Placebo Q8W (Placebo Responder) | Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 1 | 10 | 2 | 4 | 4 | 21 |
| Completed | 0 | 0 | 0 | 5 | 2 | 3 | 2 | 4 |
| Not completed | 0 | 0 | 1 | 5 | 0 | 1 | 2 | 17 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 6 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline | 6.5 (1.9 to 11.2) | 69.3 (64.9 to 73.7) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90) | 6.5 (1.9 to 11.2) | 64.3 (59.7 to 68.9) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) | 0.9 (0.0 to 2.8) | 17.0 (13.4 to 20.6) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) | 9.3 (3.8 to 14.9) | 82.5 (78.9 to 86.1) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100) | 0.9 (0.0 to 2.8) | 32.4 (27.9 to 36.8) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement | 0.9 (0.0 to 2.8) | 49.2 (44.4 to 53.9) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline | 0 (0.0 to 0.0) | 19.0 (15.2 to 22.8) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| 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 | 5.4 (0.8 to 10.1) | 54.7 (49.7 to 59.7) |
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 | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W |
|---|---|---|---|
| Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period | 18.7 (10.7 to 26.7) | 85.6 (78.3 to 92.8) | 84.6 (77.2 to 92.0) |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline | -1.13 ± 1.29 | -5.83 ± 0.72 |
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). LS Mean was calculated using 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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline | -2.70 ± 0.95 | -20.03 ± 0.55 |
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). LS Mean was calculated using 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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline | -2.04 ± 1.60 | -9.01 ± 0.89 |
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
| score on a scale | Placebo Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS) | 0.35 ± 0.69 | 5.21 ± 0.43 |
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
| score on a scale | Placebo Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change From Baseline on the SF-36 Mental Component Summary (MCS) | 0.32 ± 0.73 | 5.10 ± 0.46 |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline | 1.0 (0.0 to 2.8) | 69.5 (65.0 to 73.9) |
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
| score on a scale | Placebo Q4W | 250 mg Miri Q4W |
|---|---|---|
| Absenteeism | 0.10 ± 1.87 | -3.57 ± 1.12 |
| Presenteeism | -4.54 ± 2.39 | -24.79 ± 1.42 |
| Overall Absenteeism and Presenteeism | -3.45 ± 2.82 | -24.54 ± 1.68 |
| Impairment in Activities Performed Outside of Work | -6.83 ± 2.27 | -29.73 ± 1.41 |
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. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (\<100 kg or \>=100 kg), and geographic region (North America or Other) as fixed factors.
| score on a scale | Placebo Q4W | 250 mg Miri Q4W |
|---|---|---|
| Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11 | -4.95 ± 1.94 | -4.42 ± 1.43 |
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 Q4W | 250 mg Miri Q4W |
|---|---|---|
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1) | 8.7 (3.3 to 14.1) | 57.1 (52.4 to 61.9) |
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
| micrograms per milliliter(micrograms/mL) | 250 mg Miri Q4W |
|---|---|
| Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16 | 2.00 ± 139 |
Collected over Baseline Up To 64 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Q4W | 0/107 (0%) | 2/107 (1.9%) | 51/107 (47.7%) |
| 250 mg Miri Q4W | 0/422 (0%) | 5/422 (1.2%) | 199/422 (47.2%) |
| Placebo Q4W to Placebo Q8W (Placebo Responder) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 0/94 (0%) | 0/94 (0%) | 0/94 (0%) |
| 250 mg Miri Q4W Responders to Placebo Q8W | 0/91 (0%) | 3/91 (3.3%) | 49/91 (53.8%) |
| 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 0/90 (0%) | 1/90 (1.1%) | 61/90 (67.8%) |
| 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 0/91 (0%) | 3/91 (3.3%) | 55/91 (60.4%) |
| 250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders) | 0/140 (0%) | 0/140 (0%) | 0/140 (0%) |
| Relapse | 0/47 (0%) | 0/47 (0%) | 17/47 (36.2%) |
| Placebo Q4W to Placebo Q8W (Responder) Follow-up Period | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Placebo Q4W Discontinued During Induction-Follow-up Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Placebo Q4W to Placebo Non-Responder-Follow-up Period | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| 250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| 250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 250 Miri Q4W Discontinued During Induction-Follow-up | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| 250 Miri Q4W to Miri Nonresponder-Follow-up Period | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Event | Placebo Q4W | 250 mg Miri Q4W | Placebo Q4W to Placebo Q8W (Placebo Responder) | Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders) | Relapse | Placebo Q4W to Placebo Q8W (Responder) Follow-up Period | Placebo Q4W Discontinued During Induction-Follow-up Period | Placebo Q4W to Placebo Non-Responder-Follow-up Period | 250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period | 250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period | 250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period | 250 Miri Q4W Discontinued During Induction-Follow-up | 250 Miri Q4W to Miri Nonresponder-Follow-up Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/107 | 0/422 | 0/7 | 0/94 | 0/91 | 1/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Acute myocardial infarctionCardiac disorders | 0/107 | 0/422 | 0/7 | 0/94 | 1/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| CholecystitisHepatobiliary disorders | 0/107 | 0/422 | 0/7 | 0/94 | 1/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| AppendicitisInfections and infestations | 0/107 | 0/422 | 0/7 | 0/94 | 0/91 | 0/90 | 1/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| EpilepsyNervous system disorders | 0/107 | 0/422 | 0/7 | 0/94 | 0/91 | 0/90 | 1/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Glomerulonephritis membranousRenal and urinary disorders | 0/107 | 0/422 | 0/7 | 0/94 | 0/91 | 0/90 | 1/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| TonsillectomySurgical and medical procedures | 0/107 | 0/422 | 0/7 | 0/94 | 1/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Bile duct stoneHepatobiliary disorders | 1/107 | 0/422 | 0/7 | 0/94 | 0/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Ligament ruptureInjury, poisoning and procedural complications | 1/107 | 0/422 | 0/7 | 0/94 | 0/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Arthritis bacterialInfections and infestations | 0/107 | 1/422 | 0/7 | 0/94 | 0/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Event | Placebo Q4W | 250 mg Miri Q4W | Placebo Q4W to Placebo Q8W (Placebo Responder) | Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders) | 250 mg Miri Q4W Responders to Placebo Q8W | 250 mg Miri Q4W Responders to 125 mg Miri Q8W | 250 mg Miri Q4W Responder to 250 mg Miri Q8W | 250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders) | Relapse | Placebo Q4W to Placebo Q8W (Responder) Follow-up Period | Placebo Q4W Discontinued During Induction-Follow-up Period | Placebo Q4W to Placebo Non-Responder-Follow-up Period | 250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period | 250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period | 250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period | 250 Miri Q4W Discontinued During Induction-Follow-up | 250 Miri Q4W to Miri Nonresponder-Follow-up Period |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 14/107 | 55/422 | 0/7 | 0/94 | 15/91 | 13/90 | 9/91 | 0/140 | 2/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Upper respiratory tract infectionInfections and infestations | 0/107 | 16/422 | 0/7 | 0/94 | 7/91 | 5/90 | 10/91 | 0/140 | 1/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Injection site painGeneral disorders | 5/107 | 22/422 | 0/7 | 0/94 | 2/91 | 5/90 | 6/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Vaginal infectionInfections and infestations | 0/33 | 1/124 | 0/4 | 0/27 | 0/30 | 0/26 | 0/32 | 0/34 | 1/16 | 0/1 | 0/1 | 0/6 | 0/2 | 0/4 | 0/2 | 0/1 | 0/7 |
| HeadacheNervous system disorders | 5/107 | 10/422 | 0/7 | 0/94 | 2/91 | 5/90 | 4/91 | 0/140 | 1/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/107 | 10/422 | 0/7 | 0/94 | 5/91 | 3/90 | 3/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| Back painMusculoskeletal and connective tissue disorders | 2/107 | 3/422 | 0/7 | 0/94 | 3/91 | 4/90 | 2/91 | 0/140 | 2/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| PharyngitisInfections and infestations | 3/107 | 7/422 | 0/7 | 0/94 | 0/91 | 3/90 | 4/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| AnxietyPsychiatric disorders | 0/107 | 0/422 | 0/7 | 0/94 | 4/91 | 0/90 | 0/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/107 | 9/422 | 0/7 | 0/94 | 2/91 | 2/90 | 4/91 | 0/140 | 0/47 | 0/1 | 0/4 | 0/6 | 0/2 | 0/4 | 0/4 | 0/5 | 0/16 |
All randomized participants.
| Age, Continuous(years) | Placebo Q4W | 250 mg Miri Q4W | Total |
|---|---|---|---|
| Mean | 45.7 ± 13.70 | 46.4 ± 13.56 | 46.3 ± 13.58 |
| Sex: Female, Male(Participants) | Placebo Q4W | 250 mg Miri Q4W | Total |
|---|---|---|---|
| Female | 33 | 124 | 157 |
| Male | 74 | 299 | 373 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Q4W | 250 mg Miri Q4W | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 13 | 17 |
| Not Hispanic or Latino | 11 | 53 | 64 |
| Unknown or Not Reported | 92 | 357 | 449 |
| Race (NIH/OMB)(Participants) | Placebo Q4W | 250 mg Miri Q4W | Total |
|---|---|---|---|
| American Indian or Alaska Native | 14 | 50 | 64 |
| Asian | 33 | 139 | 172 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 2 | 6 |
| White | 56 | 231 | 287 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo Q4W | 250 mg Miri Q4W | Total |
|---|---|---|---|
| South Korea | 11 | 45 | 56 |
| Puerto Rico | 5 | 15 | 20 |
| United States | 16 | 69 | 85 |
| Japan | 10 | 44 | 54 |
| Taiwan | 12 | 49 | 61 |
| Poland | 11 | 44 | 55 |
| Mexico | 15 | 61 | 76 |
| Germany | 16 | 58 | 74 |
| Russia | 11 | 38 | 49 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Apr 2018 to primary completion in Mar 2019, 10 months.
Results were first posted in Sep 2020, 1 year 6 months after primary completion. A results delay was requested in Mar 2020.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 10 months is below that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mirikizumab