Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis

Sponsor
Alvotech Swiss AG
Study ID
NCT03849404
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48

Study Details

Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.

Key Dates

Start date
Feb 20, 2019
Status verified
Dec 2019
Primary completion
Dec 23, 2019
Completion
Jul 20, 2020

Study Design

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

Arms

  • Experimental: AVT02 100mg/mL (Adalimumab Biosimilar)
    Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48
  • Experimental: EU-Humira 100mg/mL (Adalimumab Originator)
    Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline to Week 16 ]

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