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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03535194




Registration number
NCT03535194
Ethics application status
Date submitted
14/05/2018
Date registered
24/05/2018

Titles & IDs
Public title
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Scientific 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
Secondary ID [1] 0 0
I6T-MC-AMAJ
Secondary ID [2] 0 0
16504
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Secukinumab

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.

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.

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.

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.

Experimental: Japan GPP/EP - Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.


Treatment: Drugs: Mirikizumab
Administered SC

Treatment: Drugs: Placebo
Administered SC

Treatment: Drugs: Secukinumab
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving a 75% Improvement in PASI 75
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With =1% of Body Surface Area (BSA) With Psoriasis Involvement
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of =1 at Baseline
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Change From Baseline on the SF-36 Mental Component Summary (MCS)
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
Timepoint [11] 0 0
Baseline, Week 16
Secondary outcome [12] 0 0
Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score =11.
Timepoint [12] 0 0
Baseline, Week 16
Secondary outcome [13] 0 0
Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
Week 16
Secondary outcome [15] 0 0
Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
Timepoint [15] 0 0
Week 16

Eligibility
Key inclusion criteria
* Participant must have chronic plaque psoriasis for at least 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2020
Sample size
Target
Accrual to date
Final
1484
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [3] 0 0
Clinical Trials SA Pty Ltd - Adelaide
Recruitment hospital [4] 0 0
Skin and Cancer Foundation Inc. - Carlton
Recruitment hospital [5] 0 0
Fremantle Dermatology - Perth
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5073 - Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
6160 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Mendoza
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Ontario
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Quebec
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Czechia
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Hl. M. Praha
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Cedex
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France
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Le Mans Cedex 1
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Martigues
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Rouen cedex
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Toulouse cedex 9
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Germany
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Baden-Württemberg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Oroshaza
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Afula
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Tel Aviv
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Milano
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Rome
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Firenze
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Roma
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Aichi
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Korea, Republic of
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Goyang-si
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Gyeonggi-do
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Korea
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Korea, Republic of
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Seoul
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Kujawsko-pomorskie
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Lodzkie
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Lubelskie
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Pomorskie
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Slaskie
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Zachodniopomorskie
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Lodz
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Poland
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Poznan
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Puerto Rico
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Bayamón
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Puerto Rico
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Caguas
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Puerto Rico
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Carolina
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Valencia
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Spain
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Vizcaya
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
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Sevilla
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United Kingdom
State/province [119] 0 0
Greater Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03535194