A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

Sponsor
Bioeq GmbH
Study ID
NCT04595409
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • FYB202 (Proposed ustekinumab biosimilar) — DRUG
    Patients will receive 1 subcutaneous (SC) injection of FYB202 at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.
  • Stelara® (Ustekinumab) — DRUG
    Patients will receive 1 subcutaneous (SC) injection of Stelara® at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.

Study Details

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.

Key Dates

Start date
Nov 9, 2020
Status verified
Feb 2023
Primary completion
Jun 7, 2021
Completion
Mar 21, 2022

Study Design

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

Arms

  • Experimental: FYB202 (Proposed ustekinumab biosimilar)
    Patients will receive subcutaneous injections of FYB202 as detailed in the protocol.
  • Active Comparator: Stelara® (Ustekinumab)
    Patients will receive subcutaneous injections of Stelara® as detailed in the protocol.

Primary Outcome Measure

Percent improvement in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Week 12 ]

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