NCT03090100

A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,048 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

Detailed description

The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example\[e.g\] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Guselkumab	Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
DRUG	Placebo	Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
DRUG	Secukinumab	Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.

Timeline

• Start date: 2017-04-27
• Primary completion: 2018-08-02
• Completion: 2018-09-20
• First posted: 2017-03-24
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

142 sites across 9 countries: United States, Australia, Canada, Czechia, France, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study