Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis
Completed · Phase 1
Conditions studied: Moderate to Severe Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT02607774
- Run by
- Novartis Pharmaceuticals
- People needed
- 25
- Starts
- 2015-12-17
- Expected to finish
- 2016-12-20
- Last updated by the study team
- 2020-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Novartis Investigative Site — Birmingham, Alabama, United States
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Hot Springs, Arkansas, United States
- Novartis Investigative Site — Fair Lawn, New Jersey, United States
- Novartis Investigative Site — Verona, New Jersey, United States
- Novartis Investigative Site — Dallas, Texas, United States
- Novartis Investigative Site — Webster, Texas, United States
- Novartis Investigative Site — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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