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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03535194
Registration number
NCT03535194
Ethics application status
Date submitted
14/05/2018
Date registered
24/05/2018
Date last updated
30/03/2021
Titles & IDs
Public title
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
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Secondary ID [1]
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I6T-MC-AMAJ
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Secondary ID [2]
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16504
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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0
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Secukinumab
Experimental: 250mg Q4W/250mg Q8W Mirikizumab - 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.
Experimental: 250mg Q4W/125mg Q8W 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.
Experimental: Placebo/250mg 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.
Active Comparator: 300mg Secukinumab - 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.
Experimental: Japan GPP/EP - Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Treatment: Drugs: Mirikizumab
Administered SC
Treatment: Drugs: Placebo
Administered SC
Treatment: Drugs: Secukinumab
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
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Assessment method [2]
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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).
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Timepoint [2]
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Week 16
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Secondary outcome [1]
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Percentage of Participants Achieving a 75% Improvement in PASI 75
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Assessment method [1]
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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).
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants With =1% of Body Surface Area (BSA) With Psoriasis Involvement
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Assessment method [2]
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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.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of =1 at Baseline
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Assessment method [3]
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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.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [6]
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Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
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Assessment method [6]
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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).
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Timepoint [6]
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Baseline, Week 16
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Secondary outcome [7]
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Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline, Week 16
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Secondary outcome [8]
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Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Change From Baseline on the SF-36 Mental Component Summary (MCS)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 16
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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Week 16
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Secondary outcome [11]
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Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 16
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Secondary outcome [12]
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Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score =11.
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Week 16
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Secondary outcome [13]
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Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
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Assessment method [13]
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Minimum observed serum Ctrough,ss of mirikizumab
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Timepoint [13]
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Week 16
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Secondary outcome [14]
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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)
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Assessment method [14]
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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.
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Timepoint [14]
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Week 16
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Secondary outcome [15]
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Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
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Assessment method [15]
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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).
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Timepoint [15]
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Week 16
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Eligibility
Key inclusion criteria
- Participant must have chronic plaque psoriasis for at least 6 months.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant must not be breastfeeding or nursing woman.
- Participant must not have had serious, opportunistic, or chronic/recurring infection
within 3 months.
- Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within
12 months or received live vaccine(s) (including attenuated live vaccines) within 12
weeks of baseline or intend to receive either during the study.
- Participant must not have any other skin conditions (excluding psoriasis).
- Participant must not have previous exposure to Cosentyx and any other biologic therapy
targeting IL-17 (including Taltz).
- Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8
weeks.
- Participant must not have previous exposure to any biologic therapy targeting IL-23
(including Stelara).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/06/2020
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Sample size
Target
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Accrual to date
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Final
1484
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Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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Recruitment hospital [2]
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Veracity Clinical Research Pty Ltd - Woolloongabba
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Recruitment hospital [3]
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Clinical Trials SA Pty Ltd - Adelaide
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Recruitment hospital [4]
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Skin and Cancer Foundation Inc. - Carlton
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Recruitment hospital [5]
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Fremantle Dermatology - Perth
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5073 - Adelaide
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment postcode(s) [5]
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6160 - Perth
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Recruitment outside Australia
Country [1]
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0
United States of America
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Alabama
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California
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Florida
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0
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Georgia
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0
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Idaho
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Illinois
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Indiana
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Kentucky
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United States of America
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Louisiana
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0
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Maryland
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0
0
United States of America
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Massachusetts
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0
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Missouri
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New Jersey
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0
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New York
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0
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North Carolina
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0
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Ohio
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0
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Oregon
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0
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Rhode Island
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0
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Texas
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0
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Utah
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Virginia
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0
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Mendoza
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Hl. M. Praha
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Czechia
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Jihomoravský Kraj
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Czechia
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Stredoceský Kraj
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Czechia
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Ustecký Kraj
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Czechia
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Novy Jicin
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France
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Cedex
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France
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Bordeaux Cedex
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France
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Le Mans Cedex 1
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France
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Martigues
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France
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Montpellier
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0
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France
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Nice cedex 3
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0
0
France
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Rouen cedex
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0
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France
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Toulouse cedex 9
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Germany
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Baden-Württemberg
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Germany
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Hessen
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0
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Germany
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Niedersachsen
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0
0
Germany
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Nordrhein-Westfalen
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0
0
Germany
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0
0
Schleswig-Holstein
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Berlin
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hamburg
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Bacs-Kiskun
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Hajdu-Bihar
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Jasz-Nagykun-Szolnok
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Budapest
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Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Oroshaza
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Country [57]
0
0
Hungary
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State/province [57]
0
0
Veszprem
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Country [58]
0
0
Israel
Query!
State/province [58]
0
0
Afula
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Beer Sheva
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Haifa
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Petach Tikva
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Ramat Gan
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Tel Aviv
Query!
Country [64]
0
0
Italy
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State/province [64]
0
0
Milano
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Country [65]
0
0
Italy
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State/province [65]
0
0
Rome
Query!
Country [66]
0
0
Italy
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State/province [66]
0
0
Firenze
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Roma
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Aichi
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Chiba
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Fukuoka
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Gunma
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Hokkaido
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Ibaraki
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Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Kanagawa
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Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Kyoto
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Mie
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Miyagi
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Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Nagano
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Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Okinawa
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Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Osaka
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Shiga
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Tokyo
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Yamaguchi
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Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Yamanashi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Gifu
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Nagaski
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Tokushima
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Wakayama
Query!
Country [89]
0
0
Korea, Republic of
Query!
State/province [89]
0
0
Goyang-si
Query!
Country [90]
0
0
Korea, Republic of
Query!
State/province [90]
0
0
Gyeonggi-do
Query!
Country [91]
0
0
Korea, Republic of
Query!
State/province [91]
0
0
Korea
Query!
Country [92]
0
0
Korea, Republic of
Query!
State/province [92]
0
0
Seoul
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Dolnoslaskie
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Kujawsko-pomorskie
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Lodzkie
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Lubelskie
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Malopolskie
Query!
Country [98]
0
0
Poland
Query!
State/province [98]
0
0
Mazowieckie
Query!
Country [99]
0
0
Poland
Query!
State/province [99]
0
0
Podlaskie
Query!
Country [100]
0
0
Poland
Query!
State/province [100]
0
0
Pomorskie
Query!
Country [101]
0
0
Poland
Query!
State/province [101]
0
0
Slaskie
Query!
Country [102]
0
0
Poland
Query!
State/province [102]
0
0
Zachodniopomorskie
Query!
Country [103]
0
0
Poland
Query!
State/province [103]
0
0
Lodz
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Poznan
Query!
Country [105]
0
0
Puerto Rico
Query!
State/province [105]
0
0
Bayamón
Query!
Country [106]
0
0
Puerto Rico
Query!
State/province [106]
0
0
Caguas
Query!
Country [107]
0
0
Puerto Rico
Query!
State/province [107]
0
0
Carolina
Query!
Country [108]
0
0
Puerto Rico
Query!
State/province [108]
0
0
Ponce
Query!
Country [109]
0
0
Puerto Rico
Query!
State/province [109]
0
0
San Juan
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Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Alicante
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Country [111]
0
0
Spain
Query!
State/province [111]
0
0
Badalona
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
Valencia
Query!
Country [113]
0
0
Spain
Query!
State/province [113]
0
0
Vizcaya
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Barcelona
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Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Cordoba
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Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Madrid
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Pontevedra
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Sevilla
Query!
Country [119]
0
0
United Kingdom
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State/province [119]
0
0
Greater Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03535194
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
all 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Query!
Address
0
0
Eli Lilly and Company
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03535194
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