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

Sponsor
Alvotech Swiss AG
Study ID
NCT04453137
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Key Dates

Start date
Jun 30, 2020
Status verified
May 2022
Primary completion
May 31, 2021
Completion
Nov 16, 2021

Study Design

Enrollment
567 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Humira 40 mg/mL (Adalimumab Originator)
    During the LeadIn Period, patients will receive Humira (initial dose of 80 mg \[2 × 40 mg\] administered subcutaneously \[SC\], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index \[PASI\] ≥ 75 \[PASI75\]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module.
  • Active Comparator: IC - Humira 40 mg/mL (Adalimumab Originator)
    patients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections)
  • Experimental: IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar)
    patients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26: * Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), * Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), * Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections).
  • Experimental: AVT02 40 mg/mL (Adalimimab Biosimilar)
    At Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 \[PASI50\]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52.

Primary Outcome Measure

Area under the concentration-time curve over the dosing interval from Week 26 to Week 28 (AUCtau,26-28) [ Time Frame: Week 26 to Week 28 ]

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