OASIS 3 - Extension study of Mirikizumab in Plaque Psoriasis
Research type
Research Study
Full title
A Multicenter, Long-Term Extension to Evaluate the Long-Term Safety and Maintenance of Treatment Effect of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis. OASIS-3
IRAS ID
251681
Contact name
Richard Warren
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-003299-30
Duration of Study in the UK
4 years, 8 months, 25 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 comorbid diseases. The effect on quality of life can be tremendous. Involvement of the scalp, face, nail, 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 a protein called IL23 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 evaluate the long-term safety and maintenance of treatment effect of Mirikizumab in patients with moderate-to-severe plaque psoriasis. To be eligible, patients must have completed the final visit of a qualifying study period for originator study AMAJ and satisfy study AMAH entry criteria. Study assessments include: Physical examinations, ECGs, blood and urine tests and questionnaires. All patients will receive subcutaneous administration of Mirikizumab every 8 weeks for approximately 4 years; administered by clinical staff for the initial 2 years and self-administered by the trial participant/caregiver for 2 years thereafter.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0176
Date of REC Opinion
7 Jun 2019
REC opinion
Further Information Favourable Opinion