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Trial record 2 of 5 for:    Mirikizumab | psoriasis

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

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ClinicalTrials.gov Identifier: NCT03535194
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : January 27, 2020
Estimated Study Completion Date : April 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

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

Active Comparator: Secukinumab
Secukinumab administered SC
Drug: Secukinumab
Administered SC




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving a 75% Improvement in PASI 75 [ Time Frame: Week 4 ]
    Percentage of participants achieving a 75% improvement in PASI 75.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  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 (PatGA) of Disease Severity [ Time Frame: Baseline, Week 16 ]
    Change from baseline on PatGA of disease severity.

  11. 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.

  12. 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

  13. Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab [ Time Frame: Week 16 ]
    Minimum observed serum Ctrough,ss of mirikizumab



Information from the National Library of Medicine

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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:

  • 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).

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): NCT03535194


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

  Show 188 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03535194     History of Changes
Other Study ID Numbers: 16504
I6T-MC-AMAJ ( Other Identifier: Eli Lilly and Company )
2017-003286-10 ( EudraCT Number )
First Posted: May 24, 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:
Interleukin-23 (IL-23)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs