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A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

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: NCT03535194
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Percentage of Participants with a Static Physician's Global Assessment (sPGA) of (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 in Psoriasis Area and Severity Index (PASI 90) from Baseline [ Time Frame: Week 16 ]
    Percentage of participants achieving a ≥90% improvement in PASI 90 from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Percentage of Participants Achieving a 75% Improvement in PASI 75 [ Time Frame: Week 4 ]
    Percentage of participants achieving a 75% improvement in 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) Symptom Score of 0 in Those with PSS Symptom Score of ≥1 at Baseline [ Time Frame: Week 16 ]
    Percentage of participants with a PSS symptoms score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score of ≥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 from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Baseline, Week 16 ]
    Change from baseline in palmoplantar psoriasis severity index (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: Baseline, Week 16 ]
    Change in PSSI total score in participants with scalp involvement at baseline.
  • Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Baseline, Week 16 ]
    Change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
  • Change from Baseline on the 36-Item Short-Form Health Survey (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 (PatGA) of Disease Severity [ Time Frame: Baseline, Week 16 ]
    Change from baseline on PatGA of disease severity.
  • Change from baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores [ Time Frame: Baseline, Week 16 ]
    Change from baseline for the WPAI PSO.
  • Change from Baseline in Quick Inventory of Depressive Symptomatology (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 Ctrough,ss of mirikizumab
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Percentage of Participants Achieving a 75% Improvement in PASI 75 [ Time Frame: Week 4 ]
    Percentage of participants achieving a 75% improvement in 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) Symptom Score of 0 in Those with PSS Symptom Score of ≥1 at Baseline [ Time Frame: Week 16 ]
    Percentage of participants with a PSS symptoms score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score of ≥1 at baseline.
  • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) with DLQI Baseline Score >1 [ Time Frame: Week 16 ]
    Percentage of participants achieving DLQI (0,1) with DLQI baseline score >1.
  • Percent Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Baseline, Week 16 ]
    Percent change from baseline in palmoplantar psoriasis severity index (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: Baseline, Week 16 ]
    Percent change in PSSI total score in participants with scalp involvement at baseline.
  • Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Baseline, Week 16 ]
    Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
  • Change from Baseline on the 36-Item Short-Form Health Survey (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 (PatGA) of Disease Severity [ Time Frame: Baseline, Week 16 ]
    Change from baseline on PatGA of disease severity.
  • Change from baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores [ Time Frame: Baseline, Week 16 ]
    Change from baseline for the WPAI PSO.
  • Change from Baseline in Quick Inventory of Depressive Symptomatology (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 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 Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Official Title  ICMJE 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
Brief Summary The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for 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
  • Drug: Secukinumab
    Administered SC
Study Arms  ICMJE
  • Experimental: Mirikizumab
    Mirikizumab administered subcutaneously (SC)
    Intervention: Drug: Mirikizumab
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Drug: Placebo
  • Active Comparator: Secukinumab
    Secukinumab administered SC
    Intervention: Drug: Secukinumab
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
1443
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 11, 2020
Actual Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have chronic plaque psoriasis for at least 6 months.

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).
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 Argentina,   Australia,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03535194
Other Study ID Numbers  ICMJE 16504
I6T-MC-AMAJ ( Other Identifier: Eli Lilly and Company )
2017-003286-10 ( 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: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2020

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