A Study of Mirikizumab in Participants With Plaque Psoriasis

Lilly

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Mirikizumab; Drug: Drug Cocktail

Study type: Interventional

Funder types: Industry

Identifiers

NCT03718884

I6T-MC-AMBP (Other Identifier)

17117 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

29 participants in 2 patient groups

Drug Cocktail

Experimental group

Description:

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

Treatment:

Drug: Drug Cocktail

Mirikizumab + Drug Cocktail

Experimental group

Description:

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.

Treatment:

Drug: Drug Cocktail

Drug: Mirikizumab