A Study of Mirikizumab in Participants With Plaque Psoriasis

NCT03718884 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17117I6T-MC-AMBP
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (10)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam

  Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours; post-dose

• PK: Cmax of Warfarin

  PK: Cmax of Warfarin

  Period 1: Day 1: predose,1,2, 4,6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose,1,2,4,6,8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours, Day 120: 96 hours;post-dose

• PK: Cmax of Dextromethorphan

  PK: Cmax of Dextromethorphan

  Period 1: Day 1: predose, 1, 2, 4, 6, 8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose

• PK: Cmax of Omeprazole

  PK: Cmax of Omeprazole

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

• PK: Cmax of Caffeine

  PK: Cmax of Caffeine

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

• PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam

  PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours;post-dose

• PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin

  PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Warfarin

  Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours, Day 5: 96 hours; Period 2: Day 116: predose, 1, 2, 4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours,Day 119: 72 hours,Day 120: 96 hours;post-dose

• PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan

  PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Dextromethorphan

  Period 1: Day 1: predose,1,2,4,6,8 and 10 hours, Day 2: 24 hours, Day 3: 48 hours, Day 4: 72 hours; Period 2: Day 116: predose, 1, 2,4, 6, 8 and 10 hours, Day 117: 24 hours, Day 118: 48 hours, Day 119: 72 hours;post-dose

• PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole

  PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Omeprazole

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

• PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine

  PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Caffeine

  Period 1: Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 2: 24 hours, Day 3: 48 hours; Period 2: Day 116: predose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours, Day 117: 24 hours, Day 118: 48 hours;post-dose

Study Arms (2)

Drug Cocktail

EXPERIMENTAL

Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally

Drug: Drug Cocktail

Mirikizumab + Drug Cocktail

EXPERIMENTAL

Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113) Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116.

Drug: Drug Cocktail; Drug: Mirikizumab

Interventions

Drug Cocktail DRUG

Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally

Drug Cocktail; Mirikizumab + Drug Cocktail

Mirikizumab DRUG

Administered SC

Also known as: LY3074828

Mirikizumab + Drug Cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 25, 2018
• Study Start: October 23, 2018
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: January 29, 2024
• Results First Posted: January 29, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)