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 |
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.
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
sites
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