Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Sponsor
LEO Pharma
Study ID
NCT04533737
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brodalumab — BIOLOGICAL
    Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
  • Placebo — OTHER
    The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance
  • Guselkumab — BIOLOGICAL
    Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection

Study Details

The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

Key Dates

Start date
Dec 17, 2020
Status verified
Feb 2024
Primary completion
Sep 8, 2022
Completion
Dec 7, 2022

Study Design

Enrollment
113 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (brodalumab + dummy 1)
    Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks.
  • Active Comparator: Arm 2 (guselkumab + dummy 2)
    Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.

Primary Outcome Measure

Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 [ Time Frame: Week 16 ]

Related Studies