Conditions: Plaque Type Psoriasis
Keywords: plaque type psoriasis equivalent efficacy safety and immunogenicity GP2017 Humira®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 465
Healthy volunteers: no

Brief summary:
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Detailed description:
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Arms:
arm 1: Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. arm 2: Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Interventions: intervention 1: GP2017 Adalimumab intervention 2: Humira ® Adalimumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: