IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE)
| Autor: | Khusru Asadullah, Andreas Pinter, Kilian Eyerich, Friedmann J H Taut, Holger Bartz, Ernesto J. Muñoz-Elías, Sven Wegner, Knut Schäkel, Peter Weisenseel, Kristian Reich |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Antibodies Monoclonal Humanized Interleukin-23 Severity of Illness Index Immunophenotyping Double-Blind Method Psoriasis Area and Severity Index Psoriasis Internal medicine medicine Interleukin 23 Clinical endpoint Humans Multicenter Studies as Topic Dosing ddc:610 Randomized Controlled Trials as Topic business.industry Antibodies Monoclonal General Medicine medicine.disease Blockade Treatment Outcome Guselkumab Clinical Trials Phase III as Topic Medicine business |
| Zdroj: | BMJ Open, Vol 11, Iss 9 (2021) |
| Popis: | BackgroundGuselkumab is an interleukin (IL)-23 pathway blocker with proven efficacy in patients with moderate-to-severe plaque psoriasis. Early intervention with guselkumab may result in changes to the clinical disease course versus later intervention.Methods and analysisHere we present the rationale and design of a phase 3b, randomised, double-blind, multicentre study (GUIDE), comparing treatment effects of guselkumab in patients with short (≤2 years) or longer (>2 years) duration of plaque-type psoriasis, measured from first appearance of psoriatic plaques. Participants achieving skin clearance (Psoriasis Area and Severity Index (PASI)=0) by week 20 and maintaining complete clearance at week 28 visit (‘super-responders’ (SRe)) will be randomised to continue approved maintenance dosing every 8 weeks (q8w) versus an investigational maintenance dosing interval of 16 weeks (q16w) until week 68. Primary endpoint: proportion of participants in the q8w vs q16w arms with absolute PASI Ethics and disseminationApproval obtained from ethics committee Medical Council Hamburg, Germany (PVN5925). GUIDE is compliant with the Declaration of Helsinki.Trial registration numberRegistered at ClinicalTrials.gov (NCT03818035). All primary endpoint results (prespecified analyses) will be submitted to peer-reviewed, international journals within 18 months after primary completion date. |
| Databáze: | OpenAIRE |
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