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A Study of Mirikizumab in Participants With Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Drug Cocktail
Mirikizumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anaheim Clinical Trials, LLC
  • Avail Clinical Research LLC
  • High Point Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Drug Cocktail

Mirikizumab + Drug Cocktail

Arm Description

Drug cocktail administered orally once in Period 1

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

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
PK: Cmax of Midazolam
PK: Cmax of Warfarin
PK: Cmax of Warfarin
PK: Cmax of Dextromethorphan
PK: Cmax of Dextromethorphan
PK: Cmax of Omepraxole
PK: Cmax of Omepraxole
PK: Cmax of Caffeine
PK: Cmax of Caffeine
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Midazolam
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
December 21, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03718884
Brief Title
A Study of Mirikizumab in Participants With Plaque Psoriasis
Official Title
Evaluation of the Effect of Mirikizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
October 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Cocktail
Arm Type
Experimental
Arm Description
Drug cocktail administered orally once in Period 1
Arm Title
Mirikizumab + Drug Cocktail
Arm Type
Experimental
Arm Description
Drug cocktail administered orally once in Period 2 (day 116). Mirikizumab administered subcutaneously (SC) on multiple occasions in Period 2.
Intervention Type
Drug
Intervention Name(s)
Drug Cocktail
Intervention Description
Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam
Description
PK: Cmax of Midazolam
Time Frame
Period 1, Day 1 Predose through Period 2, Day 117
Title
PK: Cmax of Warfarin
Description
PK: Cmax of Warfarin
Time Frame
Period 1, Day 1 Predose through Period 2, Day 120
Title
PK: Cmax of Dextromethorphan
Description
PK: Cmax of Dextromethorphan
Time Frame
Period 1, Day 1 Predose through Period 2, Day 119
Title
PK: Cmax of Omepraxole
Description
PK: Cmax of Omepraxole
Time Frame
Period 1, Day 1 Predose through Period 2, Day 118
Title
PK: Cmax of Caffeine
Description
PK: Cmax of Caffeine
Time Frame
Period 1, Day 1 Predose through Period 2, Day 118
Title
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam
Description
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Midazolam
Time Frame
Period 1, Day 1 Predose through Period 2, Day 117
Title
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
Description
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin
Time Frame
Period 1, Day 1 Predose through Period 2, Day 120
Title
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
Description
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan
Time Frame
Period 1, Day 1 Predose through Period 2, Day 119
Title
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole
Description
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omepraxole
Time Frame
Period 1, Day 1 Predose through Period 2, Day 118
Title
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
Description
PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine
Time Frame
Period 1, Day 1 Predose through Period 2, Day 118

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
High Point Clinical Trials Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Mirikizumab in Participants With Plaque Psoriasis

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