OASIS-2 Mirikizumab in Moderate To Severe Plaque Psoriasis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis (OASIS-2)
IRAS ID
243204
Contact name
Richard Warren
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2017-003286-10
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Psoriasis is a common, lifelong, life-shortening, chronic inflammatory skin disease expressed as red, thick, scaly plaques.
Plaque psoriasis is the most common form and has been shown to have a significant impact on the overall health of patients.
Approximately a third of patients with plaque psoriasis suffer from moderate to severe disease. The life span of such patients may be shortened by up to 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, related to plaques, can especially impact a patients’ quality of life and is detrimental to work productivity and sleep. Topical, systemic and phototherapy treatments are available, however, most patients do not reach high level response or complete skin clearance.
Recent studies identified that IL23, a protein involved in inflammation, plays a significant role in inflammation and alteration of skin function leading to the skin lesions of psoriasis.
Mirikizumab (the study drug) is a monoclonal antibody designed to suppress the activity of IL23 in the psoriasis disease pathway and therefore reduce inflammation. Mirikizumab has been tested in previous studies, demonstrating significant improvement of symptoms in patients with moderate to severe plaque psoriasis. The purpose of this study is to compare the efficacy and safety of mirikizumab to secukinumab and placebo in a similar patient population over 52 weeks of treatment.
To be eligible for this study patients must be aged 18 years and over, present with chronic plaque psoriasis, for at least 6 months, and be a candidate for phototherapy and/or systemic therapy. Study assessments include: Physical examinations, ECGs, Chest X-ray, blood and urine tests and questionnaires. Study drug is given via weekly injections for one month, then every 4 weeks thereafter.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0223
Date of REC Opinion
17 May 2018
REC opinion
Further Information Favourable Opinion