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

Amgen

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: ABP 501; Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05073315

20200497

2021-000542-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 2 patient groups

Continued-use Group (Adalimumab)

Active Comparator group

Description:

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

Treatment:

Drug: Adalimumab

Switching Group (Adalimumab - ABP 501)

Experimental group

Description:

Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.

Treatment:

Drug: Adalimumab

Drug: ABP 501