A Study of Ixekizumab in Participants With Plaque Psoriasis

Status:	Completed
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - Any
Updated:	3/14/2019
Start Date:	December 22, 2016
End Date:	November 21, 2017

Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

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