Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:March 2013
End Date:January 2015
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to evaluate the serum concentration of ixekizumab after
administration using either prefilled syringe or auto-injector in participants with moderate
to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety
extension.


Inclusion Criteria:

- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic
psoriasis vulgaris for at least 6 months prior to randomization

- At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization

- Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and
Severity Index (PASI) score of at least 12 at screening and at randomization

- Candidate for phototherapy and/or systemic therapy

- Men must agree to use a reliable method of birth control during the study

- Women must agree to use birth control or remain abstinent during the study and for at
least 12 weeks after stopping treatment

Exclusion Criteria:

- Pustular, erythrodermic, and/or guttate forms of psoriasis

- History of drug-induced psoriasis

- Clinically significant flare of psoriasis during the 12 weeks prior to randomization

- Concurrent or recent use of any biologic agent

- Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light
therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis
treatment within the previous 2 weeks prior to randomization

- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
prior to randomization and during the study

- Have participated in any study with interleukin-17 (IL-17) antagonists, including
Ixekizumab

- Serious disorder or illness other than plaque psoriasis

- Serious infection within the last 3 months

- Breastfeeding or nursing (lactating) women
We found this trial at
22
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Wyomissing, PA
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Albuquerque, NM
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Arlington Heights, Illinois 60004
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Exton, PA
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Greensboro, North Carolina 27401
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