A Study in Participants With Moderate to Severe Psoriasis (NCT01107457) | Clinical Trial Compass
CompletedPhase 2
A Study in Participants With Moderate to Severe Psoriasis
United States142 participantsStarted 2010-04
Plain-language summary
The primary purpose for this study is to help answer the following research questions
* The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
* Whether ixekizumab can help participants with Psoriasis.
* How much ixekizumab should be given to participants.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Common to Both Part A:
* Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.
* Participant is a candidate for systemic therapy
* Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization
Inclusion Criterion Specific to Part B
* Participant has completed the treatment period for part A (at least through week 20)
Inclusion Criterion Specific to Part C
* Participant has completed the treatment period for part B
Exclusion Criteria Common to Part A, B and C:
* Participant has pustular, erythrodermic and/or guttate forms of psoriasis
* Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry
* Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \>28 days, infliximab or adalimumab \>56 days, alefacept \>60 days, ustekinumab \>8 months, or any other biologic agent/monoclonal antibody \>5 half-lives prior to baseline
* Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \[PUVA\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis …
What they're measuring
1
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Timeframe: Week 12
2
Percentage of PASI Improvement From Baseline to 12 Week Endpoint