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A Study of Mirikizumab in Participants With Plaque Psoriasis

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: NCT03718884
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE October 23, 2018
Actual Primary Completion Date October 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 117 ]
    PK: Cmax of Midazolam
  • PK: Cmax of Warfarin [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 120 ]
    PK: Cmax of Warfarin
  • PK: Cmax of Dextromethorphan [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 119 ]
    PK: Cmax of Dextromethorphan
  • PK: Cmax of Omepraxole [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: Cmax of Omepraxole
  • PK: Cmax of Caffeine [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: Cmax of Caffeine
  • PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 117 ]
    PK: AUC Time Zero to Infinity (AUC[0-∞]) of Midazolam
  • PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 120 ]
    PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
  • PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 119 ]
    PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
  • PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole
  • PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mirikizumab in Participants With Plaque Psoriasis
Official Title  ICMJE Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary

This study is known as a "drug interaction study." The purpose is to learn how commonly used drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and their breakdown products get into the bloodstream after taking a "cocktail" (combination) of them before and after multiple doses of mirikizumab.

The study will last about 23 weeks for each participant. Screening must be completed within 4 weeks prior to study start.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Drug Cocktail
    Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
  • Drug: Mirikizumab
    Administered SC
    Other Name: LY3074828
Study Arms  ICMJE
  • Experimental: Drug Cocktail
    Drug cocktail administered orally once in Period 1
    Intervention: Drug: Drug Cocktail
  • Experimental: Mirikizumab + Drug Cocktail
    Drug cocktail administered orally once in Period 2 (day 116). Mirikizumab administered subcutaneously (SC) on multiple occasions in Period 2.
    Interventions:
    • Drug: Drug Cocktail
    • Drug: Mirikizumab
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: December 21, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
30
Actual Study Completion Date  ICMJE October 28, 2019
Actual Primary Completion Date October 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
  • Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site

Exclusion Criteria:

  • Pregnant or nursing (lactating)
  • History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
  • Have major surgery within 8 weeks prior to first admission to the clinical site or during the study
  • Have a history of lymphoma, leukemia, or any malignancy
  • Require treatment with the cocktail drugs within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
  • Have participated in any other study with mirikizumab
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03718884
Other Study ID Numbers  ICMJE 17117
I6T-MC-AMBP ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
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: No
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 December 2019

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