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A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02899988
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Mirikizumab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Actual Study Start Date : September 14, 2016
Actual Primary Completion Date : June 19, 2017
Estimated Study Completion Date : May 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Dose 1 Mirikizumab
Mirikizumab administered subcutaneously (SC).
Drug: Mirikizumab
Administered SC
Other Name: LY3074828

Experimental: Dose 2 Mirikizumab
Mirikizumab administered SC.
Drug: Mirikizumab
Administered SC
Other Name: LY3074828

Experimental: Dose 3 Mirikizumab
Mirikizumab administered SC.
Drug: Mirikizumab
Administered SC
Other Name: LY3074828

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




Primary Outcome Measures :
  1. Proportion of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Proportion of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Week 16 ]
  2. Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [ Time Frame: Week 16 ]
  3. Proportion of Participants with a Static Physician Global Assessment (sPGA) 0 and 0/1 [ Time Frame: Week 16 ]
  4. Mean Change from Baseline on the Psoriasis Symptom Scale [ Time Frame: Baseline, Week 16 ]
  5. Mean Change from Baseline on the Patient Global Assessment [ Time Frame: Baseline, Week 16 ]
  6. Mean Change from Baseline on the Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline, Week 16 ]
  7. Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [ Time Frame: Baseline, Week 16 ]
  8. Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 104 ]


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Ages Eligible for Study:   18 Years to 75 Years   (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% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
    • sPGA score of ≥3 at screening and baseline
  • Candidate for biologic treatment for psoriasis.

Exclusion Criteria:

  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
  • Breastfeeding or nursing (lactating) women.
  • Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
  • Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to 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 8 weeks prior to baseline.
  • Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

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): NCT02899988


  Show 40 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: NCT02899988     History of Changes
Other Study ID Numbers: 16481
I6T-MC-AMAF ( Other Identifier: Eli Lilly and Company )
2016-001098-34 ( EudraCT Number )
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 1, 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.


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

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