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A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482011
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE April 24, 2018
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Percentage of Participants with a Static Physician's Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline [ Time Frame: Week 16 ]
    Percentage of participants with an sPGA of (0,1) with at least a 2-point improvement from baseline.
  • Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90) [ Time Frame: Week 16 ]
    Percentage of participants achieving a PASI 90.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Percentage of Participants with a Static Physician's Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline [ Time Frame: Week 16 ]
    Proportion of participants with an sPGA of (0,1) with at least a 2-point improvement from baseline.
  • Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90) [ Time Frame: Week 16 ]
    Proportion of participants achieving a PASI 90.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75) [ Time Frame: Week 4 ]
    Percentage of participants achieving a PASI 75.
  • Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement [ Time Frame: Week 16 ]
    Percentage of participants with ≤1% of BSA with psoriasis involvement.
  • Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline [ Time Frame: Week 16 ]
    Percentage of participants with a PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline.
  • 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 [ Time Frame: Week 16 ]
    Percentage of participants achieving a 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.
  • Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Week 16 ]
    Change in PPASI total score in participants with palmoplantar involvement at baseline.
  • Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline [ Time Frame: Week 16 ]
    Change in PSSI total score in participants with scalp involvement at baseline.
  • Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Week 16 ]
    Change in NAPSI total score in participants with fingernail involvement at baseline.
  • Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the SF-36 PCS.
  • Change from Baseline on the SF-36 Mental Component Summary (MCS) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the SF-36 MCS.
  • Change from Baseline on Patient's Global Assessment of Psoriasis (PatGA) of Disease Severity [ Time Frame: Baseline, Week 16 ]
    Change from baseline on PatGA of disease severity.
  • Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the WPAI-PSO.
  • Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11 [ Time Frame: Baseline, Week 16 ]
    Change from baseline in QIDS-SR16 total score in those with a baseline QIDS-SR16 total score ≥11.
  • Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab [ Time Frame: Week 16 ]
    Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75) [ Time Frame: Week 4 ]
    Proportion of participants achieving a PASI 75.
  • Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement [ Time Frame: Week 16 ]
    Proportion of participants with ≤1% of BSA with psoriasis involvement.
  • Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline [ Time Frame: Week 16 ]
    Proportion of participants with a PSS symptoms score of 0 in those with a PSS symptoms score ≥1 at baseline.
  • Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) in those with a DLQI Baseline Total Score >1 [ Time Frame: Week 16 ]
    Proportion of participants achieving a DLQI total score of (0,1) in those with a DLQI baseline total score >1.
  • Percent Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Week 16 ]
    Percent change in PPASI total score in participants with palmoplantar involvement at baseline.
  • Percent Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline [ Time Frame: Week 16 ]
    Percent change in PSSI total score in participants with scalp involvement at baseline.
  • Percent Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Week 16 ]
    Percent change in NAPSI total score in participants with fingernail involvement at baseline.
  • Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the SF-36 PCS.
  • Change from Baseline on the SF-36 Mental Component Summary (MCS) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the SF-36 MCS.
  • Change from Baseline on Patient's Global Assessment of Psoriasis (PatGA) of Disease Severity [ Time Frame: Baseline, Week 16 ]
    Change from baseline on PatGA of disease severity.
  • Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the WPAI-PSO.
  • Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11 [ Time Frame: Baseline, Week 16 ]
    Change from baseline in QIDS-SR16 total score in those with a baseline QIDS-SR16 total score ≥11.
  • Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab [ Time Frame: Week 16 ]
    Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Mirikizumab
    Administered SC
    Other Name: LY3074828
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Mirikizumab
    Mirikizumab administered subcutaneously (SC)
    Intervention: Drug: Mirikizumab
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2020)
530
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
689
Actual Study Completion Date  ICMJE January 16, 2020
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Japan,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482011
Other Study ID Numbers  ICMJE 16505
I6T-MC-AMAK ( Other Identifier: Eli Lilly and Company )
2017-003298-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date February 1, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP