A Phase 3b Trial of ixekizumab compared to ustekinumab (Stelara) in Moderate to Severe Psoriasis

Phase 1

• Conditions: Moderate to severe plaque psoriasis; MedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-000892-28-PL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

-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 clinical trial of medicinal product
• Study Design: Not specified