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

NCT02607774 | Completed Phase 1 FDA Drug

• 1 other identifier: CAIN457A2110
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Plaque psoriasis; disease-drug-drug-interaction; midazolam; secukinumab

Outcome Measures

Primary Outcomes (4)

• Cmax (maximum plasma) concentration

  Days -7, 8 and 36

• AUC0-12 (area under the plasma concentration-time curve from time zero to time 12 hours )

  Days -7, 8 and 36

• AUClast (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)

  Days -7, 8 and 36

• AUCinf (area under the plasma concentration-time curve from time zero to infinity)

  Days -7, 8 and 36

Secondary Outcomes (1)

• safety and tolerability (including; Blood pressure,Pulse Rate,AEs/SAEs, Blood chemistry, Hematology, ECGs and physical exam

  Throughout the entire trial; beginning at screening through Day 253 (end of trial)

Study Arms (1)

Secukinumab

EXPERIMENTAL

Secukinumab over 24 weeks

Drug: Midazolam; Drug: AIN457

Interventions

Midazolam DRUG

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

Secukinumab

AIN457 DRUG

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

Also known as: Secukinumab

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• Subjects with known history of hypersensitivity to midazolam

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Location

Novartis Investigative Site

Hot Springs, Arkansas, 71913, United States

Location

Novartis Investigative Site

Fair Lawn, New Jersey, 07410, United States

Location

Novartis Investigative Site

Verona, New Jersey, 07044, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Webster, Texas, 77004, United States

Location

Novartis Investigative Site

Norfolk, Virginia, 23507, United States

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com
• Results for CAIN457A2110 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Interventions

Midazolam; secukinumab

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 18, 2015
• Study Start: December 17, 2015
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: December 11, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)