Protocol I1F-MC-RHBS;A 52-Week Multicenter, Randomized, Blinded, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis
- Conditions
- plaque psoriasis1000381610014982
- Registration Number
- NL-OMON42355
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
-Are at least 18 years of age;-Have had moderate to severe plaque psoriasis for at least 6 months;-Have had a failure, contraindication, or intolerability to at least 1 systemic;therapy (including cyclosporine, methotrexate, or phototherapy)
-Have forms of psoriasis other than plaque psoriasis. ;-Have recently received certain treatments for their psoriasis (in particular within the last 4 weeks but the restriction can go up to 12 months for some treatments). ;-Have received ustekinumab. ;-Have already been treated with ixekizumab or another drug with a similar mode of action.;-Have received excessive sun exposure or have used tanning booths within 4 weeks prior to receiving treatment in this study or expect to do so during the study.;-Have recently received a live vaccine (within 12 weeks prior to receiving treatment in this study) or plan to do so during the study. ;-Have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.;-Have an active or recent infection. ;-Have active or dormant tuberculosis.;-Have a compromised immune system.;-Have another disease which is not currently under control, including heart disease, uncontrolled arterial hypertension, mental illness, and other diseases.;Have either a current diagnosis or a recent history of malignant disease.;-Have allergies to certain treatments or latex.;-Are pregnant or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: The primary efficacy endpoint is PASI 90 response at Week 12.<br /><br>Safety: The following safety measures will be assessed in this study: serious<br /><br>adverse events, adverse events (AEs), AEs of special interest, physical<br /><br>evaluations, chest x-ray and tuberculosis testing, vital signs, laboratory<br /><br>evaluations (including safety-related immune markers such as neutrophil counts).<br /><br>Health Outcomes: The following health outcome measures will be administered in<br /><br>this study: Itch NRS, DLQI, Skin Pain VAS, HADS, Short Form (36-item) Health<br /><br>Survey, patient*s global assessment of disease severity, Work Productivity<br /><br>Activity Impairment questionnaire - psoriasis and European Quality of Life - 5<br /><br>Dimensions 5Level + Bolt On.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy: Secondary endpoints will be PASI 100, PASI 90, PASI 75, sPGA, Nail<br /><br>Psoriasis Severity Index, Psoriasis Scalp Severity Index, Palmoplantar<br /><br>Psoriasis Severity Index, and body surface area percentage involvement of<br /><br>psoriasis.</p><br>