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A Study of Mirikizumab in Participants With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03718884
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Drug Cocktail Drug: Mirikizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : September 22, 2019
Estimated Study Completion Date : September 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Drug Cocktail
Drug cocktail administered orally once in Period 1
Drug: Drug Cocktail
Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally

Experimental: Mirikizumab + Drug Cocktail
Drug cocktail administered orally once in Period 2 (day 116). Mirikizumab administered subcutaneously (SC) on multiple occasions in Period 2.
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




Primary Outcome Measures :
  1. 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

  2. PK: Cmax of Warfarin [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 120 ]
    PK: Cmax of Warfarin

  3. PK: Cmax of Dextromethorphan [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 119 ]
    PK: Cmax of Dextromethorphan

  4. PK: Cmax of Omepraxole [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: Cmax of Omepraxole

  5. PK: Cmax of Caffeine [ Time Frame: Period 1, Day 1 Predose through Period 2, Day 118 ]
    PK: Cmax of Caffeine

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



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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:

  • 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

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): NCT03718884


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

Locations
United States, California
Anaheim Clinical Trials, LLC Recruiting
Anaheim, California, United States, 92801
Principal Investigator: Peter J Winkle         
United States, Florida
Avail Clinical Research LLC Recruiting
DeLand, Florida, United States, 32720
Contact    386-740-0074      
Principal Investigator: Bruce G. Rankin         
United States, North Carolina
High Point Clinical Trials Center Recruiting
High Point, North Carolina, United States, 27265
Contact    (336) 841-0700 ext. 2530      
Principal Investigator: Melanie Fein         
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: NCT03718884     History of Changes
Other Study ID Numbers: 17117
I6T-MC-AMBP ( Other Identifier: Eli Lilly and Company )
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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