A Study of Ixekizumab in Participants With Plaque Psoriasis

Completed · Phase 1

Conditions studied: Psoriasis

In brief

This study is known as a "drug interaction study." The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods. Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.

Key facts

Study ID

NCT02993471

Run by

Eli Lilly and Company

People needed

28

Starts

2016-12-22

Expected to finish

2017-11-21

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females with chronic moderate or severe plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy
• Men and women of childbearing potential must agree to use a reliable method of birth control and men may not donate sperm for the duration of the study. Women must test negative for pregnancy at screening and agree not to become pregnant during the study and until the first normal period following the end of the study
• Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²), inclusive, at screening
• Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical research unit (CRU)
• Have both a Static Physicians Global Assessment (sPGA) score of ≥3 and Psoriasis Area Severity Index (PASI) score ≥12 at screening and first admission to the CRU

You may not qualify if…

• Forms of psoriasis other than chronic plaque-type
• Pregnant or nursing (lactating women)
• 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 research unit or during the study
• Have a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease, or have active or history of malignant disease, or have uncontrolled cerebrocardiovascular or neuropsychiatric disease
• Require treatment with the cocktail drugs or with inhibitors of cytochrome P450 (CYP) 3A, CYP2C9, CYP2D6, CYP2C19, CYP1A2, or with inducers of CYP3A or CYP1A2, or with rifampin (inducer of multiple CYPs) or with substrates of CYP3A, CYP2C9, CYP2D6, CYP2C19, or CYP1A2 with narrow therapeutic indices within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments
• Have any known allergy or hypersensitivity to any component of the study cocktail or ixekizumab
• Have participated in any other study with ixekizumab, secukinumab or brodalumab, or have been prescribed ixekizumab or secukinumab

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• High Point Clinical Trials Center — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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