A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535194
• Other study ID #: 16504
• Secondary ID: I6T-MC-AMAJ2017-
• Status: Completed
• Phase: Phase 3
• Start date: June 26, 2018
• Est. completion date: June 3, 2020

Study information

• Verified date: August 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1484
• Est. completion date: June 3, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant must have chronic plaque psoriasis for at least 6 months.

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).

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Mirikizumab
Administered SC
• Placebo
Administered SC
• Secukinumab
Administered SC

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	Buenos Aires
Argentina	CEDIC-Centro de Investigaciones Clinicas	Caba	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	Clinica Adventista de Belgrano	Ciudad Autonoma Buenos Aires
Argentina	Instituto de Neumonología y Dermatología	Ciudad Autonoma Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Ciudad Autonoma Buenos Aires
Argentina	Halitus Instituto Médico	Ciudad Autonoma de Buenos Aire
Argentina	Parra Dermatología	Mendoza
Australia	Clinical Trials SA Pty Ltd	Adelaide	South Australia
Australia	Skin and Cancer Foundation Inc.	Carlton	Victoria
Australia	Fremantle Dermatology	Perth	Western Australia
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Canada	Stratica Medical	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Assoicates Ltd	Halifax	Nova Scotia
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	K. Papp Clinical Research Inc	Waterloo	Ontario
Czechia	Fakultni Nemocnice U svate Anny	Brno	Jihomoravský Kraj
Czechia	Kozni ambulance Kutna Hora, s.r.o.	Kutna Hora	Stredoceský Kraj
Czechia	Kozni oddeleni	Novy Jicin
Czechia	Clintrial, s.r.o.	Praha 10	Hl. M. Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10	Hl. M. Praha
Czechia	Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem	Ustecký Kraj
France	CHU de Bordeaux Hopital Saint Andre	Bordeaux Cedex
France	CH du Mans - Pavillon Claude Monet	Le Mans Cedex 1
France	CHU Dupuytren 2	Limoges	Cedex
France	Cabinet Médical	Martigues
France	Hopital Saint Eloi	Montpellier
France	CHU de Nice Hopital de L'Archet	Nice cedex 3
France	Chu de Rouen Hopital Charles Nicolle	Rouen cedex
France	Hopital Larrey	Toulouse cedex 9
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Nordrhein-Westfalen
Germany	Klin. Forschung Berlin-Mitte GmbH	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Dermatologisches Zentrum Osnabrück Nord	Bramsche	Niedersachsen
Germany	Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude	Buxtehude	Niedersachsen
Germany	Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH	Darmstadt	Hessen
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Hautarztpraxis Dr. Leitz und Kollegen	Stuttgart	Baden-Württemberg
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Hungary	Ambrozia Kft.	Budapest
Hungary	UNO Medical Trials Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika	Debrecen	Hajdu-Bihar
Hungary	Bacs-Kiskun Megyei Korhaz	Kecskemet	Bacs-Kiskun
Hungary	Oroshaza Varosi Onkormanyzat Korhaza	Oroshaza
Hungary	Trial Pharma Kft.	Puspokladany	Hajdu-Bihar
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jasz-Nagykun-Szolnok
Hungary	MedMare Bt	Veszprem
Israel	Haemek Medical Center- Dermatology	Afula
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medical Center	Haifa
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Presidio Ospedaliero Firenze Centro Piero Palagi	Firenze
Italy	Policlinico di Tor Vergata	Roma
Italy	Policlinico Univ. Agostino Gemelli	Roma	Rome
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Japan	Asahikawa Medical College Hospital	Asahikawa	Hokkaido
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	St. Lukes International Hospital	Chuo-Ku	Tokyo
Japan	Gifu University Hospital	Gifu
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Tokyo Medical University Ibaraki Medical Center	Inashiki-gun	Ibaraki
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Gunma University Hosptial	Maebashi	Gunma
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	Nagasaki University Hospital	Nagaski
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Ryukyu University Hospital	Nakagami-gun	Okinawa
Japan	Shiga University of Medical Science Hosptial	Ohtsu-shi	Shiga
Japan	Nippon Life Hospital	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Tokushima University Hospital	Tokushima
Japan	Mie University Hospital	Tsu	Mie
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Juntendo Urayasu Hospital	Urayasu	Chiba
Japan	Wakayama MedicaL University Hospital	Wakayama
Korea, Republic of	Pusan National University Hospital	Busan	Korea
Korea, Republic of	Ilsan Paik Hospital	IlsanSeo-gu	Goyang-si
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Korea
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul	Korea
Korea, Republic of	Samsung Medical Center	Seoul	Korea
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Poland	NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm	Bialystok	Podlaskie
Poland	NZOZ ZDROWIE Osteo-Medic	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych, PI House	Gdansk	Pomorskie
Poland	Centrum Medyczne Angelius Provita	Katowice	Slaskie
Poland	Barbara Rewerska DIAMOND CLINIC	Krakow	Malopolskie
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz
Poland	Dermed Centrum Medyczne Sp. z o.o.	Lodz	Lodzkie
Poland	DermoDent, Centrum Medyczne Czajkowscy	Osielsko	Kujawsko-pomorskie
Poland	AI Centrum Medyczne	Poznan
Poland	Lubelskie Centrum Diagnostyczne	Swidnik	Lubelskie
Poland	LASER CLINIC Specjalistyczne Gabinety Lekarskie	Szczecin	Zachodniopomorskie
Poland	Centralny Szpital Kliniczny MSW Klinika Dermatologii	Warszawa	Mazowieckie
Poland	Centrum Medyczne Evimed	Warszawa	Mazowieckie
Poland	DermMEDICA Sp. z o.o.	Wroclaw	Dolnoslaskie
Puerto Rico	Santa Cruz Behavioral PSC	Bayamón
Puerto Rico	Office of Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	Office of Dr. Alma M. Cruz	Carolina
Puerto Rico	Ponce School of Medicine CAIMED Center	Ponce
Puerto Rico	GCM Medical Group PSC	San Juan
Spain	Hospital del Mar	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona	Badalona
Spain	Hospital De Basurto	Bilbao	Vizcaya
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital de Manises	Manises	Valencia
Spain	Centro de Especialidades Mollabao	Pontevedra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario La Fe de Valencia	Valencia
Spain	Hospital Marina Baixa	Villajoyosa	Alicante
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester
United States	ORA, Inc	Andover	Massachusetts
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	DelRicht Research	Baton Rouge	Louisiana
United States	David Stoll, M.D.	Beverly Hills	California
United States	Bexley Dermatology Research	Bexley	Ohio
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Treasure Valley Dermatology	Boise	Idaho
United States	PMG Research of Cary, LLC	Cary	North Carolina
United States	University of North Carolina Dermatology and Skin Cancer Cen	Chapel Hill	North Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Modern Research Associates PLLC	Dallas	Texas
United States	University Dermatology	Darien	Illinois
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	California Dermatology and Clinical Research Institute	Encinitas	California
United States	Wright State Physicians Dermatology	Fairborn	Ohio
United States	Tien Q. Nguyen, MD inc. DBA First OC Dermatology	Fountain Valley	California
United States	Dawes Fretzin Clinical Research	Indianapolis	Indiana
United States	Clinical Partners LLC	Johnston	Rhode Island
United States	Keck School of Medicine University of Southern California	Los Angeles	California
United States	Dermatology Specialist	Louisville	Kentucky
United States	Dermatologic Surgery Specialists, PC	Macon	Georgia
United States	Mount Sinai School of Medicine Dermatology Clinical Trials	New York	New York
United States	Medaphase Inc	Newnan	Georgia
United States	Dermatology Clinical Trials	Newport Beach	California
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Dermatology and Skin Cancer Specialists	Rockville	Maryland
United States	Lawrence J Green, M.D, LLC	Rockville	Maryland
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Central Dermatology PC	Saint Louis	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	San Luis Dermatology & Laser Clinic, Inc	San Luis Obispo	California
United States	Clinical Science Institute	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Dermatology Associates	Seattle	Washington
United States	The South Bend Clinic	South Bend	Indiana
United States	Jordan Valley Dermatology Center	West Jordan	Utah
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline	The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.	Week 16
Primary	Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).	Week 16
Secondary	Percentage of Participants Achieving a 75% Improvement in PASI 75	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).	Week 16
Secondary	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.	Week 16
Secondary	Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of =1 at Baseline	PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.	Week 16
Secondary	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.	Week 16
Secondary	Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline	The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.	Baseline, Week 16
Secondary	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).	Baseline, Week 16
Secondary	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline	The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).	Baseline, Week 16
Secondary	Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)	SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.	Baseline, Week 16
Secondary	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.	Baseline, Week 16
Secondary	Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA =2	The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.	Week 16
Secondary	Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.	Baseline, Week 16
Secondary	Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score =11.	QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.	Baseline, Week 16
Secondary	Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab	Minimum observed serum Ctrough,ss of mirikizumab	Week 16
Secondary	Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)	The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.	Week 16
Secondary	Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).	Week 16

External Links

•   A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)