Phase 1
Completed N=29
A Study of Mirikizumab in Participants With Plaque Psoriasis
Source: ClinicalTrials.gov NCT03718884 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam — 4.07; 4.46 Nanograms per millilitre (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Midazolam |
4.07; 4.46 | — |
| PRIMARY PK: Cmax of Warfarin |
543; 506 | — |
| PRIMARY PK: Cmax of Dextromethorphan |
1.60; 1.47 | — |
| PRIMARY PK: Cmax of Omeprazole |
369; 437 | — |
| PRIMARY PK: Cmax of Caffeine |
2400; 2340 | — |
| PRIMARY PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC [0-∞]) of Midazolam |
13.4; 15.6 | — |
| PRIMARY PK: AUC Time Zero to Infinity (AUC[0-∞]) of Warfarin |
14800; 13800 | — |
| PRIMARY PK: AUC Time Zero to Infinity (AUC[0-∞]) of Dextromethorphan |
14.6; 13.0 | — |
| PRIMARY PK: AUC Time Zero to Infinity (AUC[0-∞]) of Omeprazole |
1280; 1530 | — |
| PRIMARY PK: AUC Time Zero to Infinity (AUC[0-∞]) of Caffeine |
19700; 20800 | — |
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
Data sourced from ClinicalTrials.gov (NCT03718884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.