IXORAS S: Ixekizumab in Plaque Psoriasis
Research type
Research Study
Full title
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
IRAS ID
182269
Contact name
Christopher Griffiths
Contact email
Sponsor organisation
Eli Lilly & Company Limited
Eudract number
2015-000892-28
Duration of Study in the UK
1 years, 9 months, 23 days
Research summary
Psoriasis is a common, lifelong, and life-shortening chronic inflammatory skin disease expressed as red, thick and scaly plaques. Plaque psoriasis (hereafter psoriasis) is the most common form and has been shown to have a significant impact on the overall health of patients.
Approximately 20% to 33% of patients with psoriasis suffer from moderate-to-severe disease. The life span of such patients may be shortened by as many as 5 years, partly due to association with co-occurring diseases.
The effect on quality of life can be tremendous. Involvement of the scalp, face, genital areas, palms, and soles can be particularly debilitating. Itching, a symptom related to plaques, can especially impact patients’ quality of life and is detrimental to work productivity and sleep.
Topical therapy, phototherapy and systemic therapies are available, however, the majority of patients in trials do not reach high level response or complete skin clearance.
Recent studies have identified IL-17A, a protein involved in inflammation, in the alteration of skin functions that leads to skin lesions of psoriasis.
Ixekizumab is a humanized monoclonal antibody which is designed to suppress IL-17A and therefore reduce inflammation. Ixekizumab has been used in previous Phase 3 studies, confirming the inhibition of IL-17A in patients with moderate-to-severe psoriasis.
The purpose of this study is to compare the efficacy and safety of ixekizumab to ustekinumab in patients with moderate-to-severe plaque psoriasis over 52 weeks of treatment.
To be eligible to participate in this study patients must be aged 18 years and over and be present with chronic plaque psoriasis for at least 6 months as determined by an investigator.
Study assessments will include: Physical examinations, ECGs, Chest X-ray, blood & urine tests and questionnaires.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1151
Date of REC Opinion
21 Aug 2015
REC opinion
Further Information Favourable Opinion