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

Amgen425 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

425

Conditions

Plaque Psoriasis

Interventions

AdalimumabDRUG

Participants will receive subcutaneous (SC) injection of adalimumab

ABP 501DRUG

Participants will receive SC injection of ABP 501

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (88)

Outcomes

Primary Outcomes

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Participants analyzed according to actual treatment received.

Time frame: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Participants analyzed according to treatment received.

Time frame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Secondary Outcomes

Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Time to reach maximum serum concentration.

Time frame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Time frame: Pre-dose at Week 12, Week 16, Week 20, and Week 28

PASI Percent Improvement From Baseline (Day 1) to Week 30

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

Time frame: Baseline (Day 1) and Week 30

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, United States

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

...and 78 more locations

Number of Participants Achieving PASI 75 Response at Week 30

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Time frame: Baseline (Day 1) and Week 30

Number of Participants Achieving PASI 90 Response at Week 30

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Time frame: Baseline (Day 1) and Week 30

Number of Participants Achieving PASI 100 Response at Week 30

A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Time frame: Baseline (Day 1) and Week 30

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Time frame: Baseline up to Week 32

Number of Participants Experiencing Events of Interest (EOI)

An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.

Time frame: Baseline up to Week 32

Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization

Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Time frame: Week 16, Week 20, Week 28, Week 30, and Week 32