A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

• Status: Recruiting
• Trial end date: 2023-04-22
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months

• Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline

• Participant has no known history of latent or active tuberculosis

Exclusion Criteria:

• Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis

• Participant has an active infection or history of infections

• Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment

• Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment

• Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment

• Participant has received topical psoriasis treatment within 2 weeks prior to enrollment