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

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Adalimumab
Drug: ABP 501

Registration Number: NCT05073315

Lead Sponsor: Amgen

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 425

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switching Group (Adalimumab - ABP 501)	ABP 501	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.
Continued-use Group (Adalimumab)	Adalimumab	Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Switching Group (Adalimumab - ABP 501)	Adalimumab	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose	Participants analyzed according to actual treatment received.
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	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	Participants analyzed according to treatment received.

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	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	Time to reach maximum serum concentration.
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	Pre-dose at Week 12, Week 16, Week 20, and Week 28
PASI Percent Improvement From Baseline (Day 1) to Week 30	Baseline (Day 1) and 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).
Number of Participants Achieving PASI 75 Response at Week 30	Baseline (Day 1) and 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.
Number of Participants Achieving PASI 90 Response at Week 30	Baseline (Day 1) and 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.
Number of Participants Achieving PASI 100 Response at Week 30	Baseline (Day 1) and 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.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)	Baseline up to Week 32	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.
Number of Participants Experiencing Events of Interest (EOI)	Baseline up to Week 32	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.
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization	Week 16, Week 20, Week 28, Week 30, and Week 32	Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Trial Locations

Locations (88): 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
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Total Skin and Beauty Dermatology Center PC
🇺🇸Birmingham, Alabama, United States