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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03556202




Registration number
NCT03556202
Ethics application status
Date submitted
4/06/2018
Date registered
4/06/2018
Date last updated
18/02/2019

Titles & IDs
Public title
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Scientific title
A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
Secondary ID [1] 0 0
I6T-MC-AMAH
Secondary ID [2] 0 0
16491
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

Experimental: Mirikizumab Dose 1 - Mirikizumab administered subcutaneously (SC).

Experimental: Mirikizumab Dose 2 - Mirikizumab administered SC.


Treatment: Drugs: Mirikizumab
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 Among Those who Entered the Study with a sPGA of 0,1(sPGA) of (0,1) - Percentage of participants with an sPGA of (0,1) among those who entered the study with a sPGA of 0,1
Timepoint [1] 0 0
Baseline through Study Completion (Estimated up to Week 208)
Primary outcome [2] 0 0
Percentage of Participants who Maintained a =90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those who Entered the Study with a PASI 90 - Percentage of participants who maintained a =90% improvement in PASI 90 among those who entered the study with a PASI 90.
Timepoint [2] 0 0
Baseline through Study Completion (Estimated up to Week 208)
Secondary outcome [1] 0 0
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) - Percentage of patients achieving a 100% improvement in PASI 100.
Timepoint [1] 0 0
Baseline through Study Completion (Estimated up to Week 208)
Secondary outcome [2] 0 0
Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (free of itch, pain, stinging, and burning) in Those with a PSS Symptoms Score =1 at Baseline - Percentage of participants with a PSS symptom score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score =1 at baseline.
Timepoint [2] 0 0
Baseline through Study Completion (Estimated up to Week 208)
Secondary outcome [3] 0 0
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0,1 with Baseline Score >1 - Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0,1 with baseline score >1.
Timepoint [3] 0 0
Baseline through Study Completion (Estimated up to Week 208)
Secondary outcome [4] 0 0
Percent Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline - Percent change from baseline in PPASI total score in participants with palmoplantar involvement at baseline.
Timepoint [4] 0 0
Baseline, End of Study (Estimated Week 208)
Secondary outcome [5] 0 0
Percent Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline. - Percent change from baseline in PSSI total score in participants with scalp involvement at baseline.
Timepoint [5] 0 0
Baseline, End of Study (Estimated Week 208)
Secondary outcome [6] 0 0
Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline - Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
Timepoint [6] 0 0
Baseline, End of Study (Estimated Week 208)

Eligibility
Key inclusion criteria
- Participant must have completed the last visit of an eligible study period of
originating study.

- Participant must be willing to follow the birth control measures during and after
study treatment if woman of childbearing potential.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant must not 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 lab results, that the study
investigator thinks makes it unsafe or inappropriate for the participant to
participate in this study.

- Participant must not have stopped taking mirikizumab during a previous study if the
study investigator does not think the participant should resume taking mirikizumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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Alabama
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Arizona
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Missouri
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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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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Canada
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Alberta
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Nova Scotia
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Ontario
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Czech Republic
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Brno
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Kutna Hora
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Czechia
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Novy Jicin
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Czechia
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Praha 10
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Le Mans Cedex 1
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Limoges CEDEX
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Martigues
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Montpellier
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Nice cedex 3
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France
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Rouen cedex
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France
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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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Brandenburg
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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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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Bacs-Kiskun
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Hungary
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Csongrad
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Hungary
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Hajdu-Bihar
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Hungary
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Jasz-Nagykun-Szolnok
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Hungary
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Budapest
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Hungary
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Oroshaza
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Hungary
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Veszprem
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Israel
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Afula
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Lazio
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Italy
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Milano
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Italy
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Firenze
Country [76] 0 0
Italy
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Roma
Country [77] 0 0
Japan
State/province [77] 0 0
Aichi
Country [78] 0 0
Japan
State/province [78] 0 0
Chiba
Country [79] 0 0
Japan
State/province [79] 0 0
Fukuoka
Country [80] 0 0
Japan
State/province [80] 0 0
Gunma
Country [81] 0 0
Japan
State/province [81] 0 0
Hokkaido
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Mie
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Japan
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Miyagi
Country [87] 0 0
Japan
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Nagano
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Shiga
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Japan
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Shimane
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Yamaguchi
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Japan
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Yamanashi
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Japan
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Gifu
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Japan
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Nagaski
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Japan
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Tokushima
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Japan
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Wakayama
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Korea
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Korea, Republic of
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Daejeon
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Gwangju
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Korea, Republic of
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Seoul
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Mexico
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Baja California
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Distrito Federal
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Jalisco
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Mexico
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Michoacan Morelia
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Mexico
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Sinaloa
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Mexico
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Mexico
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Durango
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Poland
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Bialystok
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Gdansk
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Katowice
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Krakow
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Lodz
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Poland
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Osielsko
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Poznan
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Swidnik
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Szczecin
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Warszawa
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Poland
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Wroclaw
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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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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tver
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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
State/province [140] 0 0
Pontevedra
Country [141] 0 0
Spain
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Sevilla
Country [142] 0 0
Taiwan
State/province [142] 0 0
Hsinchu
Country [143] 0 0
Taiwan
State/province [143] 0 0
Kaohsiung
Country [144] 0 0
Taiwan
State/province [144] 0 0
New Taipei City
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taichung City
Country [146] 0 0
Taiwan
State/province [146] 0 0
Tainan
Country [147] 0 0
Taiwan
State/province [147] 0 0
Taipei
Country [148] 0 0
Taiwan
State/province [148] 0 0
Taoyuan Hsien
Country [149] 0 0
United Kingdom
State/province [149] 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
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of
mirikizumab in participants with moderate-to-severe plaque psoriasis.
Trial website
https://clinicaltrials.gov/show/NCT03556202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
1-877-CTLILLY (1-877-285-4559) or 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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable