Guselkumab in Psoriasis following inadequate Ustekinumab response
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
IRAS ID
161057
Contact name
Chris Griffiths
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-000721-20
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, randomised, double-blind, multicentre study evaluating the efficacy and safety of guselkumab (the study drug, a monoclonal antibody) for the treatment of participants with moderate to severe plaque-type psoriasis and an inadequate response to ustekinumab (currently licensed treatment) at Week 16.
Approximately 800 participants will be enrolled in the study and receive open-label ustekinumab. Those with inadequate response after 16 weeks will be randomized to either switch to guselkumab or continue on ustekinumab for 28 weeks. Those who respond well after 16 weeks will continue on treatment with open label ustekinumab. All participants will have an additional follow-up visit at Week 52 and a final safety visit at Week 60.
The target population is adult men or women with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months before the first administration of study drug.
?Efficacy evaluations include the investigator-reported assessments IGA and PASI; patient- reported outcome assessments include the Dermatology Life Quality Index (DLQI) and the Psoriasis Symptom and Sign Diary (PSSD). Blood samples will be collected for measuring drug levels and detection of antibodies to the trial treatments. In addition, samples will be obtained for measurement of biomarkers and genetic analysis (optional, separate consent required) .
The safety and tolerability of the study drugs (guselkumab and ustekinumab) will be monitored by collecting information on adverse events including injection site and allergic reactions, safety laboratory tests, physical examinations and assessments, review of other medication and early detection of tuberculosis.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1239
Date of REC Opinion
28 Oct 2014
REC opinion
Further Information Favourable Opinion