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

March 3, 2021 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1484

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
        • Buenos Aires Skin
      • Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
        • Instituto de Neumonología Y Dermatología
      • Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
        • Psoriahue Medicina Interdisciplinaria
      • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista de Belgrano
      • Ciudad Autonoma de Buenos Aire, Argentina, C1122AAF
        • Halitus Instituto Médico
      • Mendoza, Argentina, 5500
        • Parra Dermatología
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1425DES
        • CEDIC-Centro de Investigaciones Clinicas
  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research Pty Ltd
    • South Australia
      • Adelaide, South Australia, Australia, 5073
        • Clinical Trials SA Pty Ltd
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin and Cancer Foundation Inc.
    • Western Australia
      • Perth, Western Australia, Australia, 6160
        • Fremantle Dermatology
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1Z2
        • Eastern Canada Cutaneous Research Assoicates Ltd
    • Ontario
      • London, Ontario, Canada, N6A 3H7
        • The Guenther Dermatology Research Centre
      • Markham, Ontario, Canada, L3P1X2
        • Lynderm Research Inc
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research Inc
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc
  • Czechia
      • Novy Jicin, Czechia, 741 01
        • Kozni oddeleni
    • Hl. M. Praha
      • Praha 10, Hl. M. Praha, Czechia, 100 00
        • CLINTRIAL, s.r.o.
      • Praha 10, Hl. M. Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Jihomoravský Kraj
      • Brno, Jihomoravský Kraj, Czechia, 656 91
        • Fakultni Nemocnice U svate Anny
    • Středočeský Kraj
      • Kutna Hora, Středočeský Kraj, Czechia, 28430
        • Kozni ambulance Kutna Hora, s.r.o.
    • Ustecký Kraj
      • Usti nad Labem, Ustecký Kraj, Czechia, 40113
        • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
  • France
      • Bordeaux Cedex, France, 33075
        • CHU de Bordeaux Hôpital Saint André
      • Le Mans Cedex 1, France, 72037
        • CH du Mans - Pavillon Claude Monet
      • Martigues, France, 13500
        • Cabinet Médical
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nice cedex 3, France, 06202
        • CHU De Nice Hopital De l'Archet
      • Rouen cedex, France, 76036
        • Chu de Rouen Hopital Charles Nicolle
      • Toulouse cedex 9, France, 31059
        • Hôpital Larrey
    • Cedex
      • Limoges, Cedex, France, 87042
        • CHU Dupuytren 2
  • Germany
      • Berlin, Germany, 10783
        • Rothhaar Studien GmbH
      • Berlin, Germany, 10117
        • Klin. Forschung Berlin-Mitte GmbH
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Stuttgart, Baden-Württemberg, Germany, 70178
        • Hautarztpraxis Dr. Leitz und Kollegen
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitatsklinikum Tubingen
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
      • Frankfurt am Main, Hessen, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt
    • Niedersachsen
      • Bramsche, Niedersachsen, Germany, 49565
        • Dermatologisches Zentrum Osnabrück Nord
      • Buxtehude, Niedersachsen, Germany, 21614
        • Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
    • Nordrhein-Westfalen
      • Bad Bentheim, Nordrhein-Westfalen, Germany, 48455
        • Fachklinik Bad Bentheim
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
  • Hungary
      • Budapest, Hungary, 1135
        • UNO Medical Trials Kft.
      • Budapest, Hungary, 1238
        • Ambrozia Kft.
      • Oroshaza, Hungary, 5900
        • Oroshaza Varosi Onkormanyzat Korhaza
      • Veszprem, Hungary, 8200
        • MedMare Bt
    • Bacs-Kiskun
      • Kecskemet, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
      • Puspokladany, Hajdu-Bihar, Hungary, 4150
        • Trial Pharma Kft.
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft
  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center- Dermatology
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Firenze, Italy, 50125
        • Presidio Ospedaliero Firenze Centro Piero Palagi
      • Roma, Italy, 00133
        • Policlinico Di Tor Vergata
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
    • Rome
      • Roma, Rome, Italy, 00168
        • Policlinico Univ. Agostino Gemelli
  • Japan
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Nagaski, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Japan, 550-0006
        • Nippon Life Hospital
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Urayasu, Chiba, Japan, 279-0021
        • Juntendo Urayasu Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830 0011
        • Kurume University Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hosptial
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Asahikawa Medical College Hospital
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japan, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • Kyoto Prefectural University of Medicine
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Shinshu University Hospital
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Ryukyu University Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
    • Shiga
      • Ohtsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hosptial
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Chuo-Ku, Tokyo, Japan, 104 8560
        • St. Lukes International Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku, Tokyo, Japan, 173 8606
        • Teikyo University Hospital
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Showa University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 120-792
        • Severance Hospital Yonsei University Health System
    • Goyang-si
      • IlsanSeo-gu, Goyang-si, Korea, Republic of, 10380
        • Ilsan Paik Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Korea
      • Busan, Korea, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Incheon, Korea, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Korea, Republic of, 08308
        • Korea University Guro Hospital
  • Poland
      • Lodz, Poland, 90-242
        • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
      • Poznan, Poland, 61-113
        • AI Centrum Medyczne
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 51-318
        • dermMedica Sp. z o.o.
    • Kujawsko-pomorskie
      • Osielsko, Kujawsko-pomorskie, Poland, 86-031
        • DermoDent, Centrum Medyczne Czajkowscy
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-265
        • DERMED Centrum Medyczne Sp. z o.o.
    • Lubelskie
      • Swidnik, Lubelskie, Poland, 21-040
        • Lubelskie Centrum Diagnostyczne
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-559
        • Barbara Rewerska Diamond Clinic
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-625
        • Centrum Medyczne Evimed
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSW Klinika Dermatologii
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • Nzoz Zdrowie Osteo-Medic
      • Bialystok, Podlaskie, Poland, 15-375
        • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych, PI House
    • Slaskie
      • Katowice, Slaskie, Poland, 40-611
        • Centrum Medyczne Angelius Provita
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-332
        • LASER CLINIC Specjalistyczne Gabinety Lekarskie
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961-6911
        • Santa Cruz Behavioral PSC
      • Caguas, Puerto Rico, 00727
        • Office of Dr. Samuel Sanchez PSC
      • Carolina, Puerto Rico, 00985
        • Office of Dr. Alma M. Cruz
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group PSC
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor
      • Pontevedra, Spain, 36001
        • Centro de Especialidades Mollabao
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe de Valencia
    • Alicante
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Badalona
      • Barcelona, Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • United Kingdom
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Bakersfield, California, United States, 93309
        • Bakersfield Dermatology and Skin Cancer Medical Group
      • Beverly Hills, California, United States, 90212
        • David Stoll, M.D.
      • Encinitas, California, United States, 92024
        • California Dermatology and Clinical Research Institute
      • Fountain Valley, California, United States, 92708
        • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine University of Southern California
      • Newport Beach, California, United States, 92660
        • Dermatology Clinical Trials
      • San Luis Obispo, California, United States, 93405
        • San Luis Dermatology & Laser Clinic, Inc
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
    • Georgia
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists, PC
      • Newnan, Georgia, United States, 30263
        • Medaphase Inc
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83713
        • Treasure Valley Dermatology
    • Illinois
      • Darien, Illinois, United States, 60561
        • University Dermatology
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialist
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • DelRicht Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Dermatology and Skin Cancer Specialists
      • Rockville, Maryland, United States, 20850
        • Lawrence J Green, M.D, LLC
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology PC
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Dermatology Clinical Trials
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • PMG Research of Cary, LLC
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina Dermatology and Skin Cancer Cen
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Fairborn, Ohio, United States, 46435
        • Wright State Physicians Dermatology
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Modern Research Associates PLLC
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Dermatology Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
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.
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
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.
Drug: Placebo
Administered SC
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
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.
Drug: Secukinumab
Administered SC
EXPERIMENTAL: Japan GPP/EP
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
Time Frame: Week 16
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
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
Time Frame: Week 16
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
Time Frame: Week 16
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
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
Time Frame: Week 16
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
Percentage of Participants Achieving a 75% Improvement in PASI 75
Time Frame: Week 16
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
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
Time Frame: Week 16
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
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Time Frame: Baseline, Week 16
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
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Time Frame: Baseline, Week 16
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
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Time Frame: Baseline, Week 16
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
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Time Frame: Baseline, Week 16
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
Change From Baseline on the SF-36 Mental Component Summary (MCS)
Time Frame: Baseline, Week 16
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
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
Time Frame: Week 16
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
Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
Time Frame: Baseline, Week 16
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
Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
Time Frame: Baseline, Week 16
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
Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
Time Frame: Week 16
Minimum observed serum Ctrough,ss of mirikizumab
Week 16
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
Time Frame: Week 16
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
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
Time Frame: Week 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2018

Primary Completion (ACTUAL)

March 5, 2020

Study Completion (ACTUAL)

June 3, 2020

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (ACTUAL)

May 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16504
  • I6T-MC-AMAJ (OTHER: Eli Lilly and Company)
  • 2017-003286-10 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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