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NCT Number: NCT05073315

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beacon Dermatology, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

Participants will receive subcutaneous (SC) injection of adalimumab

Other names: Humira®

ABP 501

Drug

Participants will receive SC injection of ABP 501

Primary outcomes

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

    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

    Participants analyzed according to actual treatment received.

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

    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

    Participants analyzed according to treatment received.

Secondary outcomes

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

    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

    Time to reach maximum serum concentration.

  2. 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

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

    Time frame: 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).

  4. Number of Participants Achieving PASI 75 Response at Week 30

    Time frame: 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.

  5. Number of Participants Achieving PASI 90 Response at Week 30

    Time frame: 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.

  6. Number of Participants Achieving PASI 100 Response at Week 30

    Time frame: 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.

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

    Time frame: 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.

  8. Number of Participants Experiencing Events of Interest (EOI)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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