AzTrials
AzTrials

PsoriasisPhase 3NCT03535194

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

A Phase 3 study testing Mirikizumab and Secukinumab in people with Psoriasis, run by Eli Lilly and Company at 178 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Mirikizumab and Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,484 participants
Where
178 sitesin 16 countries
Study dates
26 Jun 2018to 3 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

178 sites in 16 countries.

178 sites in 16 countries

United States42 sites

  • ORA, Inc

    Andover, Massachusetts, 01810

  • Bakersfield Dermatology and Skin Cancer Medical Group

    Bakersfield, California, 93309

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • David Stoll, M.D.

    Beverly Hills, California, 90212

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Treasure Valley Dermatology

    Boise, Idaho, 83713

  • PMG Research of Cary, LLC

    Cary, North Carolina, 27511

  • University of North Carolina Dermatology and Skin Cancer Cen

    Chapel Hill, North Carolina, 27516

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Modern Research Associates PLLC

    Dallas, Texas, 75231

  • University Dermatology

    Darien, Illinois, 60561

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • California Dermatology and Clinical Research Institute

    Encinitas, California, 92024

  • Wright State Physicians Dermatology

    Fairborn, Ohio, 46435

  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology

    Fountain Valley, California, 92708

  • Dawes Fretzin Clinical Research

    Indianapolis, Indiana, 46250

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Keck School of Medicine University of Southern California

    Los Angeles, California, 90033

  • Dermatology Specialist

    Louisville, Kentucky, 40241

  • Dermatologic Surgery Specialists, PC

    Macon, Georgia, 31217

  • Mount Sinai School of Medicine Dermatology Clinical Trials

    New York, New York, 10029

  • Medaphase Inc

    Newnan, Georgia, 30263

  • Dermatology Clinical Trials

    Newport Beach, California, 92660

  • Virginia Clinical Research

    Norfolk, Virginia, 23502

  • Park Avenue Dermatology

    Orange Park, Florida, 32073

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas, 78660

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland, 20850

  • Lawrence J Green, M.D, LLC

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • San Luis Dermatology & Laser Clinic, Inc

    San Luis Obispo, California, 93405

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Dermatology Associates

    Seattle, Washington, 98101

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Central Dermatology PC

    St Louis, Missouri, 63117

  • Jordan Valley Dermatology Center

    West Jordan, Utah, 84088

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

Japan28 sites

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • St. Lukes International Hospital

    Chuo-Ku, Tokyo, 104 8560

  • Gifu University Hospital

    Gifu, 501-1194

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki-gun, Ibaraki, 300-0395

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Kurume University Hospital

    Kurume, Fukuoka, 830 0011

  • Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Gunma University Hosptial

    Maebashi, Gunma, 371-8511

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Nagasaki University Hospital

    Nagaski, Nagaski, 852-8501

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Ryukyu University Hospital

    Nakagami-gun, Okinawa, 903-0215

  • Shiga University of Medical Science Hosptial

    Ohtsu-shi, Shiga, 520-2192

  • Osaka City University Hospital

    Osaka, 545-8586

  • Nippon Life Hospital

    Osaka, 550-0006

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Teikyo University Hospital

    tabashi City, Tokyo, 173 8606

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Juntendo Urayasu Hospital

    Urayasu, Chiba, 279-0021

  • Wakayama MedicaL University Hospital

    Wakayama, 641-8510

Other trials in Japan

Poland14 sites

  • NZOZ ZDROWIE Osteo-Medic

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

    Bialystok, Podlaskie Voivodeship, 15-375

  • Centrum Badan Klinicznych, PI House

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Barbara Rewerska DIAMOND CLINIC

    Krakow, Lesser Poland Voivodeship, 31-559

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-242

  • Dermed Centrum Medyczne Sp. z o.o.

    Lodz, Łódź Voivodeship, 90-265

  • DermoDent, Centrum Medyczne Czajkowscy

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • AI Centrum Medyczne

    Poznan, 61-113

  • Lubelskie Centrum Diagnostyczne

    Świdnik, Lublin Voivodeship, 21-040

  • LASER CLINIC Specjalistyczne Gabinety Lekarskie

    Szczecin, West Pomeranian Voivodeship, 70-332

  • Centralny Szpital Kliniczny MSW Klinika Dermatologii

    Warsaw, Masovian Voivodeship, 02-507

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

  • DermMEDICA Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 51-318

Other trials in Poland

Germany13 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, North Rhine-Westphalia, 48455

  • Klin. Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Rothhaar Studien GmbH

    Berlin, 10783

  • Dermatologisches Zentrum Osnabrück Nord

    Bramsche, Lower Saxony, 49565

  • Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

    Buxtehude, Lower Saxony, 21614

  • Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

    Darmstadt, Hesse, 64283

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse, 60590

  • TFS Trial Form Support GmbH

    Hamburg, 20537

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Hautarztpraxis Dr. Leitz und Kollegen

    Stuttgart, Baden-Wurttemberg, 70178

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Spain12 sites

  • Hospital Germans Trias i Pujol

    Barcelona, Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital De Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital de Manises

    Manises, Valencia, 46940

  • Centro de Especialidades Mollabao

    Pontevedra, 36001

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

South Korea10 sites

  • Pusan National University Hospital

    Busan, Korea, 49241

  • Ilsan Paik Hospital

    IlsanSeo-gu, Goyang-si, 10380

  • Gachon University Gil Medical Center

    Incheon, Korea, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Korea University Guro Hospital

    Seoul, Korea, 08308

  • Konkuk University Medical Center

    Seoul, 05030

  • Seoul St. Mary's Hospital

    Seoul, 06591

  • Chungang University Hospital

    Seoul, 06973

  • Severance Hospital Yonsei University Health System

    Seoul, 120-792

Other trials in South Korea

Argentina8 sites

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1027AAP

  • CEDIC-Centro de Investigaciones Clinicas

    Caba, Buenos Aires, C1425DES

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, C1055AA0

  • Instituto de Neumonología y Dermatología

    Ciudad Autonoma Buenos Aires, C1425BEA

  • Psoriahue Medicina Interdisciplinaria

    Ciudad Autonoma Buenos Aires, C1425DKG

  • Clinica Adventista de Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

  • Halitus Instituto Médico

    Ciudad Autonoma de Buenos Aire, C1122AAF

  • Parra Dermatología

    Mendoza, 5500

Other trials in Argentina

Canada8 sites

  • Stratica Medical

    Edmonton, Alberta, T5K 1X3

  • Eastern Canada Cutaneous Research Assoicates Ltd

    Halifax, Nova Scotia, B3H1Z2

  • The Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7

  • Lynderm Research Inc

    Markham, Ontario, L3P1X2

  • Innovaderm Research Inc

    Montreal, Quebec, H2X 2V1

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • K. Papp Clinical Research Inc

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

France8 sites

  • CHU de Bordeaux Hopital Saint Andre

    Bordeaux, 33075

  • CH du Mans - Pavillon Claude Monet

    Le Mans, 72037

  • CHU Dupuytren 2

    Limoges, Cedex, 87042

  • Cabinet Médical

    Martigues, 13500

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU de Nice Hopital de L'Archet

    Nice, 06202

  • Chu de Rouen Hopital Charles Nicolle

    Rouen, 76036

  • Hopital Larrey

    Toulouse, 31059

Other trials in France

Hungary8 sites

  • UNO Medical Trials Kft.

    Budapest, 1135

  • Ambrozia Kft.

    Budapest, 1238

  • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county, 6000

  • Oroshaza Varosi Onkormanyzat Korhaza

    Orosháza, 5900

  • Trial Pharma Kft.

    Püspökladány, Hajdú-Bihar, 4150

  • Allergo-Derm Bakos Kft

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • MedMare Bt

    Veszprém, 8200

Other trials in Hungary

Czechia6 sites

  • Fakultni Nemocnice U svate Anny

    Brno, South Moravian, 656 91

  • Kozni ambulance Kutna Hora, s.r.o.

    Kutná Hora, Central Bohemia, 28430

  • Kozni oddeleni

    Nový Jičín, 741 01

  • Clintrial, s.r.o.

    Prague, Hl. M. Praha, 100 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Hl. M. Praha, 100 34

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, Ustecký Kraj, 40113

Other trials in Czechia

Israel6 sites

  • Haemek Medical Center- Dermatology

    Afula, 1834111

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Medical Center

    Haifa, 3525408

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Australia5 sites

  • Clinical Trials SA Pty Ltd

    Adelaide, South Australia, 5073

  • Skin and Cancer Foundation Inc.

    Carlton, Victoria, 3053

  • Fremantle Dermatology

    Perth, Western Australia, 6160

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

Puerto Rico5 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

  • Office of Dr. Samuel Sanchez PSC

    Caguas, PR, 00727

  • Office of Dr. Alma M. Cruz

    Carolina, PR, 00985

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716

  • GCM Medical Group PSC

    San Juan, PR, 00917

Other trials in Puerto Rico

Italy4 sites

  • Presidio Ospedaliero Firenze Centro Piero Palagi

    Florence, 50125

  • Policlinico Univ. Agostino Gemelli

    Roma, Rome, 00168

  • Policlinico di Tor Vergata

    Roma, 00133

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom1 site

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

About this study

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

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.

Conditions
Psoriasis
Being tested
Mirikizumab, Placebo, Secukinumab
Keywords
Interleukin-23 (IL-23)
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirikizumabDrug

    Also called LY3074828

    Administered SC

  • PlaceboDrug

    Administered SC

  • SecukinumabDrug

    Administered SC

Study groups in NCT03535194
Study groupRoleWhat they receive
250mg Q4W/250mg Q8W MirikizumabExperimentalParticipants 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.
Receives: Drug: Mirikizumab
250mg Q4W/125mg Q8W MirikizumabExperimentalParticipants 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.
Receives: Drug: Mirikizumab
Placebo/250mg MirikizumabExperimentalParticipants 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.
Receives: Drug: Mirikizumab; Drug: Placebo
300mg SecukinumabActive comparatorParticipants 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.
Receives: Drug: Secukinumab
Japan GPP/EPExperimentalParticipants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 16

  2. 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).

    Measured: Week 16

Secondary outcomes (15)

  1. 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).

    Measured: Week 16

  2. 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.

    Measured: Week 16

  3. 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.

    Measured: Week 16

  4. 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.

    Measured: Week 16

  5. 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.

    Measured: Baseline, Week 16

  6. 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).

    Measured: Baseline, Week 16

  7. 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).

    Measured: Baseline, Week 16

  8. 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.

    Measured: Baseline, Week 16

  9. 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.

    Measured: Baseline, Week 16

  10. 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.

    Measured: Week 16

  11. 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.

    Measured: Baseline, Week 16

  12. 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.

    Measured: Baseline, Week 16

  13. Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab

    Minimum observed serum Ctrough,ss of mirikizumab

    Measured: Week 16

  14. 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.

    Measured: Week 16

  15. 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).

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start26 Jun 2018
  3. Primary completion5 Mar 2020
  4. Study completion3 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,484 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535194
Sponsor's protocol ID
16504
Other IDs
I6T-MC-AMAJ, 2017-003286-10, 2017
Status last verified
Aug 2020
First submitted
14 May 2018
Last updated
30 Mar 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Papp K, Warren RB, Green L, Reich K, Langley RG, Paul C, Asahina A, Johnson L, Arora V, Osuntokun O, Lebwohl M. Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study. Lancet Rheumatol. 2023 Sep;5(9):e542-e552. doi: 10.1016/S2665-9913(23)00120-0. Epub 2023 Aug 21.

    PubMed 38251498

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab and Secukinumab in people with Psoriasis, run by Eli Lilly and Company at 178 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Japan, Poland, Germany, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.

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