A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/23/2018 |
Start Date: | August 2015 |
End Date: | August 3, 2017 |
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in
participants with plaque psoriasis.
participants with plaque psoriasis.
The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing
regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and
Post-Treatment Follow-Up.
regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and
Post-Treatment Follow-Up.
Inclusion Criteria:
- Present with chronic plaque psoriasis for at least 6 months prior to enrollment
- At least 10% BSA of psoriasis at screening and at enrollment
- sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
- Candidates for phototherapy and/or systemic therapy
- Participant must agree to use reliable method of birth control during the study; women
must continue using birth control for at least 12 weeks after stopping treatment
Exclusion Criteria:
- Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
prior to enrollment and during the study
- Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4
weeks; or had topical psoriasis treatment within the previous 2 weeks prior to
enrollment
- Concurrent or recent use of any biologic agent
- Have participated in any study with ixekizumab
- Received a live vaccination within 12 weeks prior to enrollment
- Serious disorder or illness other than psoriasis
- Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
- Major surgery within 8 weeks of baseline, or will require surgery during the study
- Breastfeeding or nursing (lactating) women
We found this trial at
60
sites
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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59 One Mile Road
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
609-443-4500
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University of South Florida The University of South Florida is a high-impact, global research university...
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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