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Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis

NCT ID: NCT02607774

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-17

Study Completion Date

2016-12-20

Brief Summary

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To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.

Detailed Description

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This will be an open-label, confirmatory study investigating potential disease-drug-drug interaction of secukinumab and midazolam in male and female patients with moderate-to-severe plaque psoriasis. A total of approximately 25 patients are required to obtain at least 20 completers in the study Patients who meet the eligibility criteria at screening, will have a baseline assessment day (within 1 week prior to the start of secukinumab) during which a full midazolam PK profile after a single oral dose of 5 mg will be assessed by collecting blood over the 12 hour postdose period.

On Day 1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day 22 (Week 3) and Day 29 (Week 4) patients will receive 300 mg s.c. secukinumab (2 injections of 150 mg s.c.). On Day 8 and on Day 36 (Week 5), patients will receive additional single doses of 5 mg oral midazolam (total of 3 single doses). The midazolam PK profile will be assessed over the 12 hour postdose period.

On those days when midazolam PK profiles are assessed, samples will be collected and analyzed for circulating IL-6, inflammatory panel (collected at screening, baseline and pre-dose Day 1 only), total IL-17A (after following initiation of secukinumab treatment), hsCRP and for 4-beta-hydroxycholesterol (exploratory endogenous phenotyping marker of CYP3A activity).

There will be an extended treatment period during which patients will receive secukinumab 300 mg s.c. at Weeks 8, 12, 16, 20 and 24.

Then there will be a follow-up period of 12 weeks following the last dose administered at Week 24. Visits will be at Weeks 28, 32 and 36.

Conditions

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Moderate to Severe Plaque Psoriasis

Keywords

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Plaque psoriasis disease-drug-drug-interaction midazolam secukinumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Secukinumab

Secukinumab over 24 weeks

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

midazolam administered to all patients Days -7, 1 and 35.

AIN457

Intervention Type DRUG

secukinumab administered at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24

Interventions

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Midazolam

midazolam administered to all patients Days -7, 1 and 35.

Intervention Type DRUG

AIN457

secukinumab administered at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24

Intervention Type DRUG

Other Intervention Names

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Secukinumab

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe plaque psoriasis as defined at baseline by: PASI score of 12 or greater and IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4) and Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
* Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
* Men or women at least 18 years of age or older at time of screening.

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.
* Subjects with known history of hypersensitivity to midazolam
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Hot Springs, Arkansas, United States

Site Status

Novartis Investigative Site

Fair Lawn, New Jersey, United States

Site Status

Novartis Investigative Site

Verona, New Jersey, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Webster, Texas, United States

Site Status

Novartis Investigative Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=203

A Plain Language Trial Summary is available on novartisclinicaltrials.com

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=16935

Results for CAIN457A2110 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CAIN457A2110

Identifier Type: -

Identifier Source: org_study_id