Back to resultsStudy to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
ABP 501
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis
Eligibility Criteria
Inclusion criteria:
- Men or women ≥ 18 and ≤ 75 years of age at time of screening
- Stable moderate to severe plaque psoriasis for at least 6 months before baseline
Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
- No known history of active tuberculosis
- Subject is a candidate for systemic therapy or phototherapy procedures
- Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Exclusion Criteria:
- Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
- Ongoing use of prohibited treatments
- Prior use of 2 or more biologics for treatment of psoriasis
- Previous receipt of adalimumab or a biosimilar of adalimumab
Other Inclusion/Exclusion criteria may apply
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABP 501
Adalimumab
Arm Description
Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.
Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.
Outcomes
Primary Outcome Measures
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
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).
Secondary Outcome Measures
Percentage of Participants With a PASI 75 Response at Week 16
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.
Percentage of Participants With a PASI 75 Response at Week 32
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.
Percentage of Participants With a PASI 75 Response at Week 50
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.
Percent Improvement From Baseline in PASI at Week 32
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 is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Percent Improvement From Baseline in PASI at Week 50
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 is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Percentage of Participants With a sPGA Response at Week 32
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Percentage of Participants With a sPGA Response at Week 50
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement.
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
Number of Participants With Adverse Events
The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
A serious AE is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.
Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01970488
Brief Title
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Official Title
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 18, 2013 (Actual)
Primary Completion Date
August 14, 2014 (Actual)
Study Completion Date
March 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABP 501
Arm Type
Experimental
Arm Description
Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
HUMIRA®
Intervention Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
ABP 501
Other Intervention Name(s)
Adalimumab-atto, AMJEVITA™
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Description
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 and Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PASI 75 Response at Week 16
Description
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 and Week 16
Title
Percentage of Participants With a PASI 75 Response at Week 32
Description
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 and week 32
Title
Percentage of Participants With a PASI 75 Response at Week 50
Description
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 and week 50
Title
Percent Improvement From Baseline in PASI at Week 32
Description
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 is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time Frame
Baseline and week 32
Title
Percent Improvement From Baseline in PASI at Week 50
Description
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 is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time Frame
Baseline and week 50
Title
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
Description
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame
Week 16
Title
Percentage of Participants With a sPGA Response at Week 32
Description
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame
Week 32
Title
Percentage of Participants With a sPGA Response at Week 50
Description
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame
Week 50
Title
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
Description
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement.
Time Frame
Baseline and Week 16
Title
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
Description
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
Time Frame
Baseline and week 32
Title
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
Description
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
Time Frame
Baseline and week 50
Title
Number of Participants With Adverse Events
Description
The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
A serious AE is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.
Time Frame
From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.
Title
Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
Description
Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
Time Frame
For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Men or women ≥ 18 and ≤ 75 years of age at time of screening
Stable moderate to severe plaque psoriasis for at least 6 months before baseline
Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
No known history of active tuberculosis
Subject is a candidate for systemic therapy or phototherapy procedures
Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Exclusion Criteria:
Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
Ongoing use of prohibited treatments
Prior use of 2 or more biologics for treatment of psoriasis
Previous receipt of adalimumab or a biosimilar of adalimumab
Other Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Research Site
City
Nyíregyháza
State/Province
Szabolcs-szatmar-bereg
ZIP/Postal Code
4400
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
28755394
Citation
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017 Dec;177(6):1562-1574. doi: 10.1111/bjd.15857. Epub 2017 Dec 1.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
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