A Study of Secukinumab Compared to Ustekinumab for Treatment of Patients with Plaque Psoriasis
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 16-003304
NCT ID: NCT02826603
Sponsor Protocol Number: CAIN457A2326
About this study
The purpose of this study is to assess the long-term safety, tolerability, and effectiveness of secukinumab over ustekinumab for the treatment of patients who have moderate to severe plaque psoriasis.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Subjects must give a written, signed and dated informed consent
- Chronic plaque-type psoriasis present for at least 6 months before randomization
- Moderate to severe plaque psoriasis as defined at randomization by:
- PASI score of ≥12 and
- Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
- IGA mod 2011 ≥3 (based on a scale of 0-4)
- Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
- Topical treatment (including topical corticosteroids) and/or
- Phototherapy and/or
- Previous systemic therapy
- Forms of psoriasis other than plaque psoriasis
- Drug-induced psoriasis
- Ongoing use of prohibited treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Aaron Mangold, M.D.
Closed for enrollment