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A Phase IV, Randomized, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicenter Clinical Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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Trial Profile

A Phase IV, Randomized, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicenter Clinical Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 26 Apr 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Pharmacokinetics
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 12 Mar 2024 Results assessing the pharmacokinetics (PK), efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis who switched between RP adalimumab and the high concentration formulation SB5 (40 mg/0.4 mL) adalimumab biosimilar to those receiving RP continuously, presented at the American Academy of Dermatology annual Meeting 2024.
    • 09 Mar 2024 Primary endpoint (Maximum serum concentration during the dosing interval (Cmax)) (week 23-25), has been met according to a Samsung Bioepis media release.
    • 09 Mar 2024 Primary endpoint (Area under the concentration-time curve over the dosing interval (AUCtau)) (week 23-25), has been met according to a Samsung Bioepis media release.

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