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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)

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ClinicalTrials.gov Identifier: NCT03482011
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Mirikizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 689 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : April 11, 2019
Estimated Study Completion Date : March 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Mirikizumab
Mirikizumab administered subcutaneously (SC)
Drug: Mirikizumab
Administered SC
Other Name: LY3074828

Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75) [ Time Frame: Week 4 ]
    Proportion of participants achieving a PASI 75.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change from Baseline on the SF-36 Mental Component Summary (MCS) [ Time Frame: Baseline, Week 16 ]
    Change from baseline on the SF-36 MCS.

  10. 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.

  11. 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.

  12. 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.

  13. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482011


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Show 70 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03482011     History of Changes
Other Study ID Numbers: 16505
I6T-MC-AMAK ( Other Identifier: Eli Lilly and Company )
2017-003298-32 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
Psoriasis
IL-23

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases