Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      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
    

Detailed description: 
      This is a multicenter, randomized, double-blind, parallel-group study to evaluate PK,
      efficacy, safety, and immunogenicity between patients with moderate to severe chronic plaque
      psoriasis receiving Humira and patients with moderate to severe chronic plaque psoriasis
      undergoing repeated switches between Humira and AVT02, followed by an optional safety
      Extension Phase.

      AVT02-GL-302 study is composed of 3 parts:

      LeadIn Period: Week 1-12 - OpenLabel Treatment Switching Module: Week 12-28 - DoubleBlind
      Treatment Optional Extension Phase: Week 28-52 - OpenLabel Treatment

      Lead-In Period:

      After successfully completing Screening activities, patients will be enrolled in the LeadIn
      Period.

      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.

      Switching Module:

      Group 1: 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). Group 2: patients continue to receive Humira 40 mg every other week from Week 12
      until Week 26 (8 injections) The last study treatment administration in the Double-Blind
      Switching Module is at Week 26. The last study assessment is at Week 28 for both groups. The
      end-of-study (EoS) visit for the interchangeability (IC) part of study is planned at Week 28
      (ie, 2 weeks after the last study treatment administration, EoS IC).

      Extension Phase:

      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.

      The clinical study report (CSR) for the IC part of the study will include the data from the
      OpenLabel Lead-In Period and Double-Blind Switching Module.

      The Extension Phase CSR will include the data from the additional 24-week Open-Label
      Extension Phase (Weeks 28 to 52).
    

Intervention name(s): Adalimumab originator; Adalimumab biosimilar
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injection every other week; Subcutaneous injection every other week
Other intervention name(s): Humira; AVT02
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label lead-in phase, followed by blinded 1:1 randomization with open label extension phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other