A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT03482011
Last Updated: 2020-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2018-04-24
2020-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mirikizumab
Induction Period:
Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W).
Maintenance Period:
Participants received one of the four options below:
Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90).
125 mg mirikizumab administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q8W for non-responders (\<PASI 90).
Mirikizumab
Administered SC
Placebo
Induction Period: Participants received placebo administered SC Q4W.
Maintenance Period:
Participants received one of the two options below:
Placebo administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (\< PASI 90).
Placebo
Administered SC
Interventions
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Mirikizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin at screening and baseline
* sPGA score of ≥3 at screening and baseline
* Candidate for systemic therapy and/or phototherapy for psoriasis.
Exclusion Criteria
* Breastfeeding or nursing women.
* Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening.
* 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.
* Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
* Have received topical psoriasis treatment within 14 days prior to baseline.
* Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline.
* Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Univ of Connecticut
Farmington, Connecticut, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Forward Clinical Trials, Inc
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
The South Bend Clinic
South Bend, Indiana, United States
Oregon Medical Research Center
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
University of Utah MidValley Dematology
Murray, Utah, United States
Multicare Health System
Tacoma, Washington, United States
Gemeinschaftspraxis Mahlow
Mahlow, Brandenburg, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Praxis Gerlach
Dresden, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
ISA GmbH
Berlin, , Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Clinical Research Hamburg GmbH
Hamburg, , Germany
Toho University School of Medicine, Sakura Hospital
Sakura, Chiba, Japan
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan
Kanto Rosai Hospital
Kawasaki, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Ryukyu University Hospital
Nakagami-gun, Okinawa, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-KU, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Seibo Hospital
Shinjuku-ku, Tokyo, Japan
Shirasaki Clinic
Takaoka-shi, Toyama, Japan
Centro Medico del Angel S.C.
Mexicali, Estado de Baja California, Mexico
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan, Jalisco, Mexico
Hospital de Jesus
Mexico City, Mexico City, Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morella, Michoacán, Mexico
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, Mexico
Kohler Milstein Research, S.A. de C.V.
Mérida, Yucatán, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, , Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok, , Poland
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
DermMEDICA Sp. z o.o.
Wroclaw, , Poland
Office of Dr. Alma M. Cruz
Carolina, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, , Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow, , Russia
First Moscow State Medical University n.a. Sechenov
Moscow, , Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, , Russia
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
Smolensk, , Russia
Tver State Medical University
Tver', , Russia
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Bundang CHA General Hospital
Sungnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Kyung Hee University Hospital
Seoul, Korea, South Korea
Korea University Guro Hospital
Seoul, Korea, South Korea
Ulsan University Hospital
Ulsan, Korea, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
National Taiwan University Hospital
Taipei, Zhongzheng District, Taiwan
National Taiwan University Hospital Hsin-Chu
Hsinchu, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien, , Taiwan
Countries
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References
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Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I6T-MC-AMAK
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003298-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16505
Identifier Type: -
Identifier Source: org_study_id
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