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

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT05073315

Run by

Amgen

People needed

425

Starts

2021-10-04

Expected to finish

2022-12-19

Last updated by the study team

2024-02-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johnson Dermatology Clinic — Fort Smith, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Unison Clinical Trials — Sherman Oaks, California, United States
• Revival Research — Doral, Florida, United States
• Altus Research, Inc. — Lake Worth, Florida, United States
• International Dermatology Research, Inc — Miami, Florida, United States
• Tory Sullivan MD PA — North Miami Beach, Florida, United States
• Marietta dermatology skin care — Marietta, Georgia, United States
• Georgia Skin and Cancer Clinic - Clinic — Savannah, Georgia, United States
• NorthShore University HealthSystem Dermatology — Skokie, Illinois, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• Lawrence J Green, MD, LLC — Rockville, Maryland, United States
• ALLCUTIS Research, LLC. — Beverly, Massachusetts, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• David Fivenson, MD, PLC — Ann Arbor, Michigan, United States
• Henry Ford Health System - New Center One — Detroit, Michigan, United States
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States
• Vivida Dermatology — Las Vegas, Nevada, United States
• Skin Search of Rochester, Inc. — Rochester, New York, United States
• Wilmington Dermatology Center — Wilmington, North Carolina, United States
• Wright State Physicians, Inc — Fairborn, Ohio, United States
• Dermatologists of Southwest Ohio — Mason, Ohio, United States
• Total Skin and Beauty Dermatology Center PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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