Clinical trial NCT03482011: A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
IL-23
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following 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:

* Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data.
* 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.

Primary outcomes:
measure: Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
timeFrame: Week 4
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)
timeFrame: Week 16
measure: Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
timeFrame: Week 16
measure: Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
timeFrame: Week 52
measure: Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
timeFrame: Week 16
measure: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
timeFrame: Week 16
measure: Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
timeFrame: Week 16
measure: Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)
timeFrame: Baseline, Week 16
measure: Change From Baseline on the SF-36 Mental Component Summary (MCS)
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
timeFrame: Week 16
measure: Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
timeFrame: Week 16: Day 113
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Univ of Connecticut
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center
state: Pennsylvania
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Mahlow
country: Germany
facility: Gemeinschaftspraxis Mahlow
state: Brandenburg
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Praxis Gerlach
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: ISA GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg - Eppendorf
city: Hamburg
country: Germany
facility: Clinical Research Hamburg GmbH
city: Sakura
country: Japan
facility: Toho University School of Medicine, Sakura Hospital
state: Chiba
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Nakagami-gun
country: Japan
facility: Ryukyu University Hospital
state: Okinawa
city: Nishi-ku Sakai-shi
country: Japan
facility: Kume Clinic
state: Osaka
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Shinagawa-KU
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo Hospital
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Shirasaki Clinic
state: Toyama
city: Bucheon,
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Sungnam-si
country: Korea, Republic of
facility: Bundang CHA General Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Korea
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Korea
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Mexicali
country: Mexico
facility: Centro Medico del Angel S.C.
state: Baja California
city: Mexico City
country: Mexico
facility: Hospital de Jesus
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
state: Jalisco
city: Morella
country: Mexico
facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC
state: Michoacan
city: Mazatlan
country: Mexico
facility: B&B Investigaciones Medicas, SC
state: Sinaloa
city: Merida
country: Mexico
facility: Kohler Milstein Research, S.A. de C.V.
state: Yucatan
city: Distrito Federal
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C
city: Bialystok
country: Poland
facility: NZOZ ZDROWIE Osteo-Medic
city: Lodz
country: Poland
facility: "Dermed" Centrum Medyczne Sp. z o.o.
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Wroclaw
country: Poland
facility: DermMEDICA Sp. z o.o.
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Krasnodar
country: Russian Federation
facility: GBUZ Clinical dermatology and venereological dispensary
city: Moscow
country: Russian Federation
facility: State scientific centre for dermatovenerology and cosmetolog
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. Sechenov
city: Smolensk
country: Russian Federation
facility: GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
city: St. Petersburg
country: Russian Federation
facility: SPb SBHI Skin-venerologic dispensary #10
city: Tver
country: Russian Federation
facility: Tver State Medical University
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung
city: New Taipei City
country: Taiwan
facility: Taipei Medical University- Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan Hsien
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: